Sacituzumab govitecan and pembrolizumab in TNBC | Image Credit: 

Sacituzumab govitecan-hxiy (Trodelvy) combined with pembrolizumab (Keytruda) demonstrated a predictable and manageable safety profile in patients diagnosed with PD-L1–positive, previously untreated metastatic triple-negative breast cancer (TNBC), according to a safety analysis from the phase 3 ASCENT-04 study (NCT05382286) presented at the 

Key findings indicated that, while the incidence of any treatment-emergent adverse events (TEAEs) was higher in the combination arm vs the control chemotherapy and pembrolizumab arm, the rate of TEAEs leading to dose reduction or discontinuation was lower compared with chemotherapy. Grade ≥3 TEAEs were reported in 71% of the experimental arm with an exposure-adjusted incidence rate (EAIR) of 2.19 (95% CI, 1.86–2.56) vs 70% in the chemotherapy arm with an EAIR of 2.13 (95% CI, 1.81–2.49). TEAEs that led to sacituzumab govitecan dose reduction occurred in 35% of patients (EAIR, 0.62; 95% CI, 0.49–0.78) vs 44% of patients who experienced a chemotherapy dose reduction (EAIR, 0.94; 95% CI, 0.76–1.15). Additionally, any treatment discontinuation was reported in 12% of the experimental arm (EAIR, 0.15; 95% CI, 0.10–0.21) compared with 31% in the chemotherapy arm (EAIR, 0.53; 95% CI, 0.41–0.67).

The TEAEs were consistent with the known safety profiles of sacituzumab govitecan and chemotherapy; the most common were neutropenia (65% in the experimental arm vs 60% in the chemotherapy arm), anemia (37% vs 51%), thrombocytopenia (5% vs 29%), diarrhea (70% vs 29%), colitis (6% vs 1%), nausea (68% vs 38%), pneumonitis (3% vs 8%), fatigue (58% vs 56%) and peripheral neuropathy (7% vs 21%).

In patients diagnosed with TNBC, sacituzumab govitecian plus pembrolizumab showed a manageable and predictable safety profile.

Incidence of TEAEs were higher in the experimental arm compared with the control arm whereas TEAE discontinuation and reduction rates were lower in the experimental arm.

Seventy-one percent of patients experienced grade 3 or higher TEAEs in the sacituzumab govitecian plus pembrolizumab arm compared with 70% in the chemotherapy arm.

Regarding neutropenia and diarrhea in the experimental arm, which were TEAEs of specific interest, the median times to onset were 19 (range, 6–624) days and 14 (range, 1–462) days, respectively. The respective median durations were 9 (range, 2–72) days and 7 (range, 1–709) days. Kalinsky et al, study authors, reported that the frequencies of neutropenia and diarrhea with sacituzumab govitecan and pembrolizumab were highest early in treatment. Most incidences of diarrhea were grade 1 (37%) and grade 2 (24%) in the experimental arm and managed primarily with loperamide. The use of primary prophylactic granulocyte colony-stimulating factor was associated with less frequent and less severe neutropenia in the experimental arm.

Immune-mediated AEs occurred in 30% of patients treated with sacituzumab govitecan and pembrolizumab and 40% of patients treated with chemotherapy and pembrolizumab. TEAEs of special interest associated with pembrolizumab included hypothyroidism (any-grade, 7% in the experimental arm vs 16% in the control arm), colitis (6% vs 1%), infusion reactions (5% vs 9%), hyperthyroidism (4% vs 6%), and pneumonitis (3% vs 8%).

The ASCENT-04 study randomized patients with previously untreated, locally advanced, unresectable PD-L1–positive metastatic TNBC to receive sacituzumab govitecan (10 mg/kg intravenously on days 1 and 8 of a 21-day cycle) plus pembrolizumab (200 mg on day 1 of a 21-day cycle) or pembrolizumab and chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) until disease progression or unacceptable toxicity.

 In this safety analysis, a total of 221 patients in the experimental arm and 220 in the control arm were evaluable.

The primary end point was progression-free survival (PFS); secondary end points included overall survival, overall response rate, duration of response, safety, and patient-reported outcomes.

Patient demographics were well-balanced between the treatment groups. In the chemotherapy arm, 51% of patients received taxane and 49% received gemcitabine/carboplatin. The median duration of treatment was 8.9 months for sacitizumab govitecan and 8.5 months for pembrolizumab in the experimental arm vs 6.2 months for chemotherapy and 6.4 months for pembrolizumab in the control arm.

 showed that the frontline combination of sacituzumab govitecan and pembrolizumab led to a median PFS of 11.2 months (95% CI, 9.3–16.7) by blinded independent central review vs 7.8 months (95% CI, 7.3–9.3) with chemotherapy plus pembrolizumab, translating to a 35% reduction in the risk of disease progression or death (HR, 0.65; 95% CI, 0.51–0.84; 

Kalinsky K, Schmid P, de Azambuja E, et al. Safety analysis of phase 3 ASCENT-04 study of sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro for previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC). Presented at: 2025 San Antonio Breast Cancer Symposium; December 9–12, 2025; San Antonio, Texas. Abstract P5-02-28.

Study of sacituzumab govitecan-hziy and pembrolizumab versus treatment of physician's choice and pembrolizumab in patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer (ASCENT-04). ClinicalTrials.gov. Updated September 18, 2025. Accessed December 12, 2025. https://clinicaltrials.gov/study/NCT05382286

Tolaney SM, de Azambuja E, Kalinsky K, et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. 

 2025;43(suppl 17):LBA109. doi:10.1200/JCO.2025.43.17_suppl.LBA109

Articles

Sacituzumab govitecan combined with pembrolizumab shows a manageable safety profile in PD-L1–positive, untreated metastatic triple-negative breast cancer. The ASCENT-04 study reveals higher treatment-emergent adverse events (TEAEs) in the combination arm compared to chemotherapy, but with fewer dose reductions or discontinuations. Common TEAEs include neutropenia, anemia, and diarrhea. The study highlights the early onset of neutropenia and diarrhea, managed with granulocyte colony-stimulating factor and loperamide, respectively. The combination therapy also demonstrates improved progression-free survival compared to chemotherapy, reducing disease progression risk by 35%.

Sacituzumab govitecan combined with pembrolizumab showed a manageable safety profile with lower TEAE discontinuation rates in TNBC.

Sacituzumab Govitecan Plus Pembrolizumab Yields Predictable, Manageable Safety Profile in TNBC

Less invasive surgical staging procedures such as targeted axillary dissection (TAD), sentinel lymph node biopsy (SLNB), and targeted lymph node biopsy (TLNB) was noninferior to axillary lymph node dissection (ALND) in patients with breast cancer who converted from clinically node-positive (cN+) to -negative (ycN0) lymph node status following treatment with neoadjuvant chemotherapy, according to data from the observational study AXSANA/EUBREAST 3(R) (NCT04373655).

Results from the study’s first primary end point analysis, which were shared by Thorsten Kühn, MD, PhD, during the 

 (SABCS), detailed 3-year data for the study’s co-primary end point of axillary recurrence-free survival (ARFS) for over 2500 patients who had undergone either ALND or less invasive procedures.

Kühn is also a senior physician at the department of Gynecology and Obstetrics at the University of Ulm and head of the Interdisciplinary Breast Center of The Filder Clinic in Germany.

This observational study showed that less invasive surgical staging procedures like TAD/SLNB/TLNB are noninferior to ALND in patients with breast cancer who convert from node-positive to -negative status after neoadjuvant chemotherapy. 

At 3 years, ARFS rates were low with both ALND vs TAD/SLNB/TLNB, at 99.2% (95% CI, 98.2%-100.0%) and 98.8% (95% CI, 98.1%-99.5%).

Adjusted findings from multivariate analyses indicated that these 2 procedures yielded comparable local- and regional- DRFS, breast cancer–specific survival, and OS accounting for patient factors.

What key findings from this analysis were presented at the 2025 SABCS?

At 3 years, the respective ARFS after ALND and TAD/SLNB/TLNB were 99.2% (95% CI, 98.2%-100.0%) and 98.8% (95% CI, 98.1%-99.5%), showing low rates of axillary recurrence with both procedures.

Crucially, the analysis demonstrated that less invasive procedures like TAD/SLNB/TLNB are noninferior to ALND in terms of axillary recurrence based on the lower bound of a 90% confidence interval around 3-year ARFS. With a 98.2% lower bound exceeding the noninferiority criterion of 97%, the study’s primary end point had been met.

These data confirm the strong oncologic outcomes of less invasive procedures and noninferiority to ALND, the historic standard of care that has been associated with high morbidity. The findings support the use of these procedures as staging tools for patients converting from node positivity to negativity under chemotherapy—regardless of initial tumor stage or subtype—potentially minimizing surgical morbidities and ultimately enhancing patient quality of life without compromising clinical benefit.

What additional survival outcomes were reported with both approaches?

Interim analysis data of other oncologic end points, including local- and regional- distant recurrence–free survival, breast cancer–specific survival, and overall survival (OS), were also reported during the presentation.

On univariate Cox regression, the hazard ratio (HR) for distant recurrence comparing ALND vs TAD/SLNB/TLNB was 1.41 (95% CI, 1.05-1.90). Kühn also called attention to the HRs for invasive breast cancer recurrence (1.30; 95% CI, 0.99-1.71) and OS (1.35; 95% CI, 0.89-2.04).

“In univariate analyses, high risk in the [ALND] group translated into statistically significant, more distant recurrences into marginally significant, more invasive breast cancer events in a trend toward worse [OS], but it did not translate into more axillary recurrences, regional recurrences, or local regional recurrences,” commented Kühn on the data.

To explain the observations in the univariate analyses, Kühn revisited the observed baseline differences in risk between the groups. “Patients who underwent [ALND] had a higher initial risk in terms of T stage, a higher nodal burden, had more mastectomies, more axillary radiotherapy, and more patients had residual disease,” he noted.

Upon adjustment for these factors in multivariate analyses, the differences in the univariate analysis disappeared. These adjusted interim findings suggest that the 2 procedures yield comparable results regarding these end points after accounting for patient factors.

“Further follow-up is necessary to assess long-term results and the effect of differences in staging accuracy on breast cancer-specific survival and [OS],” said Kühn on next steps.

What was the background and baseline characteristics of the AXSANA study?

The ongoing AXSANA study is a large, global, prospective cohort study launched by the European Breast Cancer Research Association of Surgical Trialists (EUBREAST) that set out to solidify the evidence base for guideline recommendations regarding axillary staging techniques, specifically among those who initially present with cN+ and later convert to ycN0 following NACT.

 Although axillary dissection is increasingly shifting toward less invasive procedures, investigators cite discordant national and institutional treatment standards for this patient group, with some moving to recommend less invasive procedures, while others continue to recommend ALND.

To that end, the study is evaluating the comparative oncologic outcomes of different axillary surgical staging procedures used with patients according to institutional and national guidelines. Specifically, the study is measuring co-primary end points of ARFS, iBCSS, patient-reported quality of life, and arm morbidity. Recruitment for the study is ongoing, with estimated study completion in 2030.

Between June 2020 and April 2025, there were 6474 patients with breast cancer enrolled in the study across 288 global sites. The present analysis included the 2632 patients who had completed first surgery by December 31, 2023. For the primary staging procedure, most (69.6%) had undergone less invasive procedures including TAD (n = 1399), SLNB (n = 419), and TLNB (n = 15), while 30.4% had undergone ALND. A majority (94.6%) of patients received post-NACT nodal radiotherapy.

Kühn declared receiving honoraria from MSD, Exact Sciences, Novartis, Lilly, Merit Medical, Sirius Pintuition, Endomag, and Daiichi Sankyo, and grant/research support from Claudia von Schilling Foundation for Breast Cancer Research, Ehmann Foundation Savognin, and Eugen & Irmgard Hahn Foundation.

Kühn, T. More versus less invasive axillary surgical staging procedures in breast cancer patients converting from a clinically node-positive to a clinically node-negative stage through neoadjuvant chemotherapy – primary endpoint analysis of the international prospective multicenter AXSANA/EUBREAST 3(R)study. Presented at: 2025 San Antonio Breast Cancer Symposium; December 9–12, 2025; San Antonio, Texas. Abstract GS2-01.

Axillary Surgery After NeoAdjuvant Treatment (AXSANA). ClinicalTrials.gov. Updated March 3, 2025. Accessed December 10, 2025. 

https://www.clinicaltrials.gov/study/NCT04373655

Less invasive surgical staging procedures, such as TAD, SLNB, and TLNB, have shown noninferiority to ALND in breast cancer patients who convert from node-positive to node-negative status post-neoadjuvant chemotherapy. The AXSANA/EUBREAST 3(R) study demonstrated comparable 3-year axillary recurrence-free survival rates between these methods and ALND. Despite initial higher risk factors in the ALND group, adjusted analyses revealed similar outcomes for distant recurrence and overall survival. The study supports less invasive procedures to reduce surgical morbidity while maintaining oncologic efficacy, with ongoing follow-up to assess long-term outcomes.

Axillary RFS at 3 years was noninferior with less vs more invasive staging procedures in node-negative breast cancer after neoadjuvant chemotherapy.  

Less Invasive Axillary Staging Yields Noninferior 3-Year Axillary RFS vs ALND in Node-Negative Breast Cancer 

The use of an aromatase inhibitor led to a significant improvement in disease-free survival (DFS) and time to distant recurrence (TTDR) as adjuvant therapy compared with a selective estrogen receptor modulator (SERM) in patients with hormone receptor–positive, HER2-positive early breast cancer, according to findings from an exploratory analysis of the phase 3 ALTTO/BIG 2-06 trial (NCT00490139) that were presented during the 

This long-term analysis examined the comparative efficacy of different types of ET used to treat patients treated with chemotherapy and anti–HER2-based therapy in the ALTTO trial, measuring DFS as a primary end point and TTDR and overall survival (OS) as secondary end points. With a median follow-up of 9.9 years, findings revealed that the use of an aromatase inhibitor was associated with improved DFS and TTDR without compromising OS, proving superiority to SERMs such as tamoxifen.

Specifically, among all patients, the 10-year DFS among those receiving an aromatase inhibitor was 80.1% compared with 76.5% receiving a SERM (adjusted HR [aHR], 0.65; 95% CI, 0.52–0.82). Subgroup analyses showed that this DFS benefit persisted regardless of patient characteristics—including menopausal status—as well as tumor and treatment characteristics. Comparing DFS for those receiving aromatase inhibitors with those receiving SERMs, the respective aHRs for postmenopausal and premenopausal patients were reported as 0.65 (95% CI, 0.50–0.85) and 0.45 (95% CI, 0.24–0.86).

In terms of recurrence, patients receiving an aromatase inhibitor had fewer local (0.9% vs 2.4%) and distant recurrences (9.3% vs 12.1%) vs those treated with SERMs. The respective 10-year TTDRs among aromatase inhibitor- and SERM-treated patients were 85.7% and 83.1% (aHR, 0.65; 95% CI, 0.50–0.85).

“There was a 3.6% absolute gain in [DFS] at 10 years with [aromatase inhibitors] over SERM… and a 2.6% absolute gain in [TTDR] at 10 years,” Matteo Lambertini, MD, PhD, presenting author, shared during the presentation.

Importantly, the improvements in DFS and TTDR by aromatase inhibitors were achieved without significantly compromising OS, as evidenced by the similar 10-year OS of 88.9% and 89.1% (aHR, 0.73; 95% CI, 0.53–1.00) with aromatase inhibitors and SERMs, respectively. The lack of significant difference in OS between the 2 types of ETs underscores the role of aromatase inhibitors in reducing the incidence of disease recurrence and enhancing long-term outcomes for this patient group.

“We hope that this data may help optimize adjuvant [ET] choices in patients with [HR+/HER2+] early breast cancer and shed light on the need to design ad hoc clinical trials in this special setting,” Lambertini, associate professor and consultant in Medical Oncology at the University of Genova - IRCCS San Martino Hospital in Italy, said.

An additional prespecified analysis provided more detailed insights for premenopausal patients. This analysis compared the efficacy of 3 different ET options: aromatase inhibitors with or without ovarian function suppression (OFS), SERM only, and SERM plus OFS. The respective 10-year DFS in the 3 groups were 90.0%, 77.3%, and 77.6%.

“So, we did not observe an additional benefit of adding OFS… to SERM,” said Lambertini regarding these figures. Lambertini also noted that no significant differences in TTDR or OS were observed between the 3 options, although survival outcomes among those receiving aromatase inhibitors were numerically superior despite not meeting statistical significance.

This analysis encompassed 10 years of follow-up in the ALTTO trial, a randomized global phase 3 trial that ran between 2007 and 2021.

 The ALTTO trial evaluated various adjuvant anti-HER2 treatments with chemotherapy in over 8000 patients with HER2+ early breast cancer: trastuzumab (Herceptin) alone, lapatinib (Tykerb) alone, a sequence of trastuzumab followed by lapatinib, and the combination of trastuzumab plus lapatinib.

This analysis included 2651 patients with centrally tested HR+/HER2+ disease and excluded those who received lapatinib alone, those with HR-negative/HER2+ disease, HR+ patients who did not start adjuvant ET, and those with HR+/HER2+ who had switched ETs during the follow-up period. Slightly less than half (42.7%) of the analytic cohort received an aromatase inhibitor for adjuvant ET, while the remainder (57.3%) received a SERM, predominantly tamoxifen (99.5%).

 Lambertini declared interests with Roche, Eli Lilly, Novartis, AstraZeneca, Pfizer, Seagen, Gilead Sciences, MSD, Exact Sciences, Pierre Fabre, Menarini, Nordic Pharma, Takeda Pharmaceuticals, Ipsen, Sandoz, Libbs, and Daiichi Sankyo.

Lambertini, M. Adjuvant aromatase inhibitor or tamoxifen in patients with hormone receptor-positive/HER2-positive early breast cancer: An exploratory analysis from the ALTTO (BIG 2-06) trial. Presented at: 2025 San Antonio Breast Cancer Symposium; December 9–12, 2025; San Antonio, Texas. Abstract GS1-03.

ALTTO (adjuvant lapatinib and/or trastuzumab treatment optimisation) study; BIG 2-06/N063D (ALTTO). ClinicalTrials.gov. Updated March 21, 2025. Accessed December 9, 2025. https://clinicaltrials.gov/study/NCT00490139

Aromatase inhibitors significantly improved disease-free survival (DFS) and time to distant recurrence (TTDR) compared to selective estrogen receptor modulators (SERMs) in hormone receptor-positive, HER2-positive early breast cancer, as shown in the ALTTO/BIG 2-06 trial. The 10-year DFS was 80.1% for aromatase inhibitors versus 76.5% for SERMs. Aromatase inhibitors also reduced local and distant recurrences without compromising overall survival (OS). In premenopausal patients, aromatase inhibitors with or without ovarian function suppression showed superior DFS compared to SERMs, although no significant differences in TTDR or OS were observed.

Adjuvant AI therapy improved DFS and TTDR vs a SERM in patients with hormone receptor–positive, HER2-positive early breast cancer.

Adjuvant Aromatase Inhibition Is Associated With Improved DFS, TTDR in HR+/HER2+ Breast Cancer

Pirtobrutinib efficacy in CLL/SLL | Image Credit: 

Pirtobrutinib (Jayprica) monotherapy showed a statistically significant improvement in progression-free survival (PFS) compared with bendamustine plus rituximab (Rituxan; BR) in the first-line treatment of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), according data presented at the 

The results from the global, randomized, phase 3 BRUIN CLL-313 study (NCT05023980) presented at the 67th ASH Annual Meeting indicate that pirtobrutinib reduced the risk of disease progression or death by approximately 80% vs standard chemoimmunotherapy (HR, 0.199; 95% CI, 0.107–0.367; 

 <.0001). Investigators noted that the data support the agent as a potential new standard of care for untreated patients, particularly older adults who may be limited to a single line of therapy.

“It was a knockout,” Wojciech Jurczak, MD, PhD, Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology in Kraków, Poland, said during the presentation. “If we compare the similar comparisons of bendamustine, other BTK inhibitors like ibrutinib [Imbruvica] or zanubrutinib [Brukinsa], the hazard ratio is about 0.35.

“[Pirtobrutinib was] effective in whichever subgroup we analyzed,” added Jurczak.

What were the efficacy data from the trial?

Pirtobrutinib demonstrated significantly improved PFS data in patients with CLL/SLL compared to BR.

OS data is still immature but is displaying trends that are favorable towards pirtobrutinib.

Pirtobrutinib achieved a favorable safety profile, with SAE rates significantly lower than BR.

At the 24-month landmark, the progression-free survival rate was 93.4% (95% CI, 87.6%–96.5%) for patients treated with pirtobrutinib vs 70.7% (95% CI, 61.5%–78.1%) for those treated with BR. This benefit was consistent across key subgroups, including patients with mutated 

Although overall survival (OS) data remain immature, a notable trend favored the pirtobrutinib arm (HR, 0.257; 95% CI, 0.070–0.934; 

 =.0261). The 24-month OS rate was 97.8% for the pirtobrutinib group compared with 90.8% for the BR group. This survival signal is particularly relevant given the high crossover rate allowed in the study design; 52.9% of patients in the BR arm crossed over to receive pirtobrutinib following confirmed disease progression.

The open-label phase 3 trial enrolled 282 patients with previously untreated CLL/SLL meeting iwCLL 2018 criteria for therapy. Patients were randomized 1:1 to receive oral pirtobrutinib 200 mg once daily or up to 6 cycles of bendamustine (90 mg/m²) plus rituximab (375-500 mg/m²). Randomization was stratified by 

Key exclusion criteria included the presence of del(17p), known central nervous system involvement, Richter transformation, or significant cardiovascular disease. The data cutoff for the current analysis was July 11, 2025.

What were the additional data from the trial?

Pirtobrutinib exhibited a favorable safety profile consistent with previous reports in the relapsed/refractory setting. Despite a significantly longer median treatment duration for pirtobrutinib (32.3 months) compared with the fixed-duration BR regimen (5.6 months), the rate of severe adverse events (AEs) was lower in the experimental arm.

Grade 3 or higher treatment-emergent AEs (TEAEs) occurred in 40.0% of patients receiving pirtobrutinib compared with 67.4% of those receiving BR. Furthermore, treatment discontinuation due to TEAEs was significantly less frequent with pirtobrutinib (4.3%) than with BR (15.2%).

Specific adverse events of interest for BTK inhibitors showed low incidence rates in the pirtobrutinib arm. Atrial fibrillation and atrial flutter (any grade) were reported in 1.4% of patients treated with pirtobrutinib compared with 0.7% in the BR arm. Among patients aged 75 years or older receiving pirtobrutinib, only 1 experienced atrial fibrillation or flutter. Rates of grade 3 or higher infections were also lower with pirtobrutinib (13.6%) compared with BR (57.1%), as were rates of grade 3 or higher neutropenia (7.1% vs 12.1%, respectively).

“Now, if we took this data together with 

 study [NCT05254743], which was presented this conference where pirtobrutinib was opposed to ibrutinib and was also a positive study,

 we can be optimistic about the approval of the compound, possibly in early 2026,” concluded Jurczak.

Jurczak W, Kwiatek M, Czyz J, et al. Pirtobrutinib vs bendamustine plus rituximab (BR) in patients with CLL/SLL: First results from a randomized phase III study Examining a non-covalent BTK inhibitor in untreated patients. Presented at: 67th Annual ASH Meeting; December 6–9, 2025; Orlando, Florida. Abstract LBA-3.

Woyach J, Qiu L, Grosicki S, et al. Pirtobrutinib vs ibrutinib in treatment-naïve and relapsed/refractory CLL/SLL: Results from the first randomized phase III study comparing a non-covalent and covalent BTK inhibitor. Blood. 2025;146(suppl 1): 683. doi:10.1182/blood-2025-683

Pirtobrutinib monotherapy demonstrated a significant improvement in progression-free survival (PFS) compared to bendamustine plus rituximab in first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The phase 3 BRUIN CLL-313 study showed an 80% reduction in disease progression or death risk with pirtobrutinib. The 24-month PFS rate was 93.4% for pirtobrutinib versus 70.7% for the comparator. Pirtobrutinib also exhibited a favorable safety profile, with lower rates of severe adverse events and treatment discontinuation. These findings suggest pirtobrutinib as a potential new standard of care for untreated CLL/SLL patients.

Pitrobrutinib monotherapy showed significant efficacy improvements in first-line CLL/SLL compared with BR treatments. 

Pirtobrutinib Yields Improved Efficacy Over BR in First-Line CLL/SLL

The microbiota-based, immunosuppressant-sparing therapy MaaT013 (Xervyteg) was tolerable and produced deep, durable responses in patients with acute graft-vs-host disease with gastrointestinal involvement (GI-aGVHD) who were refractory to corticosteroids and ruxolitinib (Jakafi), according to data from the primary analysis of the phase 3 ARES trial (NCT04769895).

These findings were presented during the 

 by Florent Malard, MD, PhD, a professor of Hematology at Saint Antoine Hospital and Sorbonne University.

As of the data cutoff on November 11, 2024, the study met its primary end point with a GI overall response rate (GI-ORR) of 62% (95% CI, 49%–74%) among 66 patients treated with MaaT013 on day 28 of treatment, significantly exceeding the historical control of 22% (

 <.0001). The all-organ ORR was 64% (95% CI, 51%–75%). Notably, both GI and all-organ responses exhibited a similar average duration of response (DOR) of 6.4 months (95% CI, 4.8–8.0).

Furthermore, data describing key secondary end points revealed that responses were maintained through later time points. At day 56 and month 3, the GI-ORRs were 49% and 44%, respectively; likewise, all-organ ORRs were 48% and 44%. Responses across all time points showed exceptionally high rates of complete response and very good partial response.

Importantly, the deep and durable responses translated into promising survival benefits. A Kaplan-Meier graph displayed a separation of curves between responders and nonresponders beginning shortly after the first administration of MaaT013, widening substantially over the course of 1 year with responders maintaining a clear survival advantage over time. Median overall survival (OS) data were immature at the time of analysis, but the estimated probability of survival at 1 year was 54%, a clinically meaningful improvement for this patient population with historically poor clinical outcomes.

MaaT013 produced a GI-ORR of 62% among 66 patients with GI-aGVHD who received the agent on day 28; this significantly exceeded the ORR of 22% seen with a historical control.

The all-organ ORR was 64%, and the average DOR was 6.4 months for both GI and all-organ responses.

The agent demonstrated acceptable tolerability. The rate of TEAEs in the overall patient population was 76%, with the most common being escherichia sepsis, general physical health deterioration, and septic shock.


MaaT013’s safety profile was determined to be acceptable. There were 157 serious treatment-emergent adverse events (AEs) reported across 76% of patients, with the most common being escherichia sepsis, general physical health deterioration, and septic shock.

There was a total of 34 treatment-related AEs across 29% of patients, which mainly comprised various bacterial infections and GI disorders. Of these events, 7 were considered serious. There were 26 fatal AEs, with 1 event of septic shock determined to be related to MaaT013 by investigators.

The phase 3 ARES trial is a single-arm, multicenter, open-label trial in Europe investigating MaaT013, a pooled allogeneic fecal microbiotherapy, as salvage therapy in adult patients with refractory GI-aGVHD.

 The primary end point of the trial is GI-ORR at day 28, assessed by an independent review committee (IRC); secondary end points include GI-ORR at day 56 and month 3, all-organ ORR at day 28, and DOR per IRC and investigator assessment, as well as OS. In the study, MaaT013 was administered as a rectal suspension as a 150-mL enema.

Patients were included if they had undergone allogeneic hematopoietic stem cell transplant, experienced an aGVHD episode with lower GI symptoms per MAGIC guidelines, and were resistant to systemic steroids and either resistant or intolerant to ruxolitinib. Key exclusion criteria included having active cytomegalovirus colitis, lines of aGVHD treatment other than steroids and ruxolitinib, hyperacute GVHD, and active uncontrolled infection.

What next steps are planned for investigating MaaT013 in GI-aGVHD based on results from this study?

Of the 66 total patients, the majority (77%) had aGVHD with involvement limited to the GI tract. Others had GI and skin involvement (17%), GI and liver involvement (3%), and involvement of all 3 organs (3%). Regarding the hypothesized mechanisms of action driving responses in the skin and liver, Malard offered some preliminary insights based on earlier research.

“So far, based on this study, we don’t have the translational data to investigate how this is working, but from the previous [phase 2] HERACLES study [NCT03225937], we already have some data on the fact that we have some systemic immunomodulatory effect of the drug, with some decrease in the proinflammatory cytokine at the systemic level, and also an increase in essential fatty acid… in the serum of the patient,” Malard explained in the question-and-answer session. “We are also going to evaluate in another study all the immune cell subsets, in particular Tregs and so on, to find if this is how it’s working.”

MaaT013 is currently under regulatory review by the EMA following submission of a marketing authorization application in June 2025, with a decision regarding approval anticipated in the second half of 2026.

 If approved, MaaT013 would become the first microbiome-based therapy for the treatment of this high-need disease.

Malard declared receiving honoraria from Priothera, Jazz Pharmaceuticals, Therakos, Sanofi, Novartis, AstraZeneca, and MSD.

Malard, F. MaaT013 for ruxolitinib-refractory acute graft-versus-host disease with gastrointestinal involvement: results from the ARES phase III trial. Presented at: 67

 American Society of Hematology Annual Meeting and Exposition; December 6–9, 2025; Orlando, Florida. Abstract 817.‌

MaaT013 as salvage therapy in ruxolitinib-refractory GI-aGVHD patients (ARES). ClinicalTrials.gov. Updated October 17, 2024. Accessed December 6, 2025. 

https://clinicaltrials.gov/study/NCT04769895

November 3, 2025: Maat Pharma announces positive phase 3 results evaluating Xervyteg® (MaaT013) in acute graft-versus-host disease selected for oral presentation at ASH Congress 2025. News release. MaaT Pharma. November 3, 2025. Accessed December 7, 2025. 

MaaT013 (Zervyteg) demonstrated tolerability and significant efficacy in patients with corticosteroid and ruxolitinib-refractory GI-aGVHD, achieving a 62% GI overall response rate in the phase 3 ARES trial. The treatment showed durable responses with a median duration of 6.4 months and promising survival benefits, with a 54% estimated 1-year survival probability. The trial, a single-arm, multicenter study, highlighted MaaT013's potential as a microbiota-based therapy. The safety profile was acceptable, with serious adverse events reported in 76% of patients. Regulatory review by the EMA is ongoing, with a decision expected in 2026.

The microbiota-based therapy had a favorable safety profile and demonstrated response-driven prolongation of survival in this patient population.  

MaaT013 Shows Tolerability, Early Efficacy in Refractory Acute GVHD With GI Involvement

Subcutaneous (SC) delivery of cevostamab was shown to be active and safe, leading to infrequent treatment-related discontinuations at target doses exceeding 120 mg in heavily pretreated patients with relapsed/refractory multiple myeloma, according to preliminary data from the phase 1b CAMMA 3 study (GO43227; ISRCTN26168155) presented during the 

Cevostomab was found to have induced deep, durable antitumor responses at target doses of 120 mg or greater. Of 52 efficacy-evaluable patients, the overall response rate (ORR) was 38.8% (95% CI, 24.1%–53.4%) across all tested dose levels. Further, the agent demonstrated a stringent complete response (sCR) in 14.3% of patients, complete response (CR) in 6.1%, very good partial response (VGPR) in 10.2%, and partial response in 8.2%. The median duration of response (DOR) was 12.3 months (95% CI, 8.3–not estimable).

Subcutaneous cevostamab showed meaningful activity and a favorable safety profile in heavily pretreated relapsed/refractory multiple myeloma, producing deep and durable responses at doses ≥120 mg with few treatment-related discontinuations.

Responses were stronger in BCMA-naive patients, who achieved a 52% ORR and longer durability of response compared with BCMA-exposed patients, suggesting prior BCMA-targeted therapy may influence outcomes.

Safety remained manageable and consistent with IV cevostamab, with mostly low-grade CRS and injection-site reactions, reversible cytopenias, and rare discontinuations.

Notably, responses were particularly pronounced among those patients who were BCMA therapy-naive, achieving an ORR of 52.0% (95% CI, 30.4%–73.6%) vs 25.0% (95% CI, 5.6%–44.4%) among those who were BCMA-exposed (n = 26, each group). The median DOR was not reached (95% CI, 11.7-not evaluable [NE]) in BCMA-naive patients and 8.3 months (95% CI, 4.9-NE) in BCMA-exposed patients, suggesting greater durability of response in BCMA-naive patients.

When asked about the markedly lower ORR in BCMA-exposed patients during the following question-and-answer session, Ho noted that while there are no definitive data to confirm drivers of these differences, several considerations regarding response duration, prior lines of therapy, and treatment timing may be relevant and are the subject of ongoing investigation.

“We did look at the timing of treatment between the BCMA-targeting agent and cevostamab. And while we don’t have absolutely clear data, it would be fair to mention that those patients who received another bispecific therapy and then received cevostamab had a shorter duration,” Ho responded. “One could hypothesize whether there is evidence of perhaps T-cell exhaustion in those patients with a short duration as low as approximately 7 weeks, whereas [in] the other 2 categories of antibody-drug conjugates [ADCs] as well as [CAR T-cell therapy], the durations were much longer, and I believe, are unlikely to have affected the results.”

Further, among the 12 patients who achieved sCR/CR, a majority (n = 8) exhibited minimal residual disease (MRD) negativity. The remaining 4 patients were either MRD-positive or had baseline calibration failure (n = 2 each).

Except for the observed low-grade injection site reactions (ISRs), the safety and efficacy figures were noted to be generally comparable with that of intravenously (IV) administered cevostamab monotherapy, supporting the potential of SC cevostamab to offer a more convenient treatment option for providers and patients and advancement in further studies.

“On the basis of these data showing a clinical[ly] active compound given in the [SC] route, cevostamab is the subject of an ongoing development program aiming to establish its efficacy and safety, either IV or [SC], when given alone or in combination with standard-of-care novel therapies,” Ho said.

Adverse effects (AEs) were mainly grades 1 or 2. The most common any-grade AEs observed in the total dose-escalation population (n = 58) included cytokine release syndrome (CRS; 69.0%), ISR (58.6%), neutropenia (31.0%), anemia (29.3%), pyrexia (25.9%), and rash (17.2%). CRS events were mostly low-grade and effectively managed with tocilizumab (Actemra), steroids, or both. ISR events were also mainly mild and low-grade and occurred early in the treatment course.

Treatment-related AEs led to cevostamab discontinuation in 3 patients. Fatal AEs occurred in 3 patients, although none were deemed related to the treatment.

“Overall, the majority of [AEs] were mild and cytopenias were generally reversible, while treatment-related [AEs] leading to discontinuation were infrequent,” Phoebe Joy Ho, MBBS, DPhil, of Royal Prince Alfred Hospital and University of Sydney, said during the presentation of results.

Findings from a phase 1 study (NCT03275103) presented at the 66th ASH Annual Meeting previously demonstrated the efficacy and safety of IV cevostamab in heavily pretreated patients with relapsed/refractory multiple myeloma.

 The CAMMA 3 study was motivated by the need to develop a more convenient formulation that could expand treatment access and utilization.

Accordingly, the objective of the study was to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of SC cevostamab in late-line relapsed/refractory multiple myeloma.

As of February 24, 2025, 58 patients were enrolled and received at least 1 dose of SC cevostamab. Patients were heavily pretreated, with a median of 5 prior lines of therapy (range, 2–11). Nearly half (48.3%) had received prior BCMA-targeted therapy, including CAR T (10.3%), ADCs (32.8%), and bispecific antibodies (8.6%).

Like the IV regimen, the CAMMA 3 treatment regimen was administered on a fixed-duration schedule. Patients received cevostamab via SC injection for 13 28-day cycles over approximately 12 months or until disease progression. In cycle 1, patients received stepped-up dosing on days 1 and 8, during which hospitalization was mandatory; the target dose, ranging between 40 and 300 mg, was then administered on day 15. Target doses were subsequently administered every 2 weeks for 5 more cycles, followed by every 4 weeks until cycle 13. Patients were premedicated with IV corticosteroids during the first 2 cycles, as well as acetaminophen and diphenhydramine for all cycles.

 Ho declared consulting roles with Gilead Sciences, Janssen Pharmaceuticals, and Pfizer; she also declared receiving research funding from Novartis and honoraria from GSK.

Ho PJ, Quach H, Delimpasi S, et al. Subcutaneous cevostamab demonstrates manageable safety and clinically meaningful activity in relapsed/refractory multiple myeloma (RRMM): first results from the phase Ib CAMMA 3 study. 

. 2025;146(suppl 1):700. doi:10.1182/blood-2025-700

Richter J, Thomas SK, Krishnan AY, et al. Cevostamab in patients with heavily pretreated relapsed/refractory multiple myeloma (RRMM): Updated results from an ongoing phase I study demonstrate clinically meaningful activity and manageable safety and inform the doses and regimen for combination studies. 

. 2024;144(suppl 1):1021. doi:10.1182/blood-2024-199542

Subcutaneous delivery of cevostamab shows promising efficacy and safety in heavily pretreated patients with relapsed/refractory multiple myeloma, achieving a 38.8% overall response rate. The study highlights a higher response rate in BCMA therapy-naive patients compared to those previously exposed. Adverse effects were mostly mild, with cytokine release syndrome and injection site reactions being the most common. The CAMMA 3 study aims to establish the convenience and effectiveness of subcutaneous cevostamab, potentially expanding treatment access. The ongoing development program explores its use alone or in combination with other therapies.

Subcutaneous cevostamab demonstrated activity and safety in patients with multiple myeloma who had received a median of 5 prior lines of therapy. 

CAMMA 3 Data Support Ongoing Investigation of Cevostamab in Heavily Pretreated Myeloma

Treatment with the anti–PD-L1 monoclonal antibody durvalumab (Imfinzi) plus 5-fluorouracil-leucovorin-oxaliplatin-docetaxel (FLOT) produced a statistically significant and clinically meaningful improvement in overall survival (OS) among patients with resectable gastric/gastroesophageal junction (GEJ) adenocarcinoma vs placebo plus FLOT, regardless of pathological status, according to results from the phase 3 MATTERHORN trial (NCT04592913) presented during the 

With a data cutoff date of September 1, 2025, the final OS analysis of the intention-to-treat population yielded a hazard ratio (HR) of 0.78 (95% CI, 0.63–0.96; 

 = .021) comparing the investigational arm with the control arm, with median OS not reached in either arm.

“The OS results of the MATTERHORN study strongly support the use of durvalumab plus chemotherapy with FLOT as a new global standard of care for patients with localized, [resectable, gastric/GEJ] adenocarcinoma,” said Josep Tabernero, MD, PhD, professor of medicine, head of the Department of Medical Oncology at Vall d’Hebron University Hospital, and director of Vall d’Hebron Institute of Oncology, Barcelona, Spain, in his presentation.

Furthermore, a survival analysis stratified by demographic and clinical characteristics showed that OS improvement was consistent across most key subgroups. Notably, a similar improvement in OS was achieved regardless of PD-L1 status. In patients who were PD-L1-positive (PD-L1 TAP ≥1%), the HR was 0.79 (95% CI, 0.63–0.99), and the HR was 0.79 (95% CI, 0.41–1.50) in patients who were PD-L1-negative (PD-L1 TAP <1%), even demonstrating identical HRs across groups.

Additional findings reported included an improvement in event-free survival (EFS), the study’s primary end point, among patients with any degree of pathological response and regardless of pathological nodal status at the time of the data cutoff on December 20, 2024.

What Are the Study Design and Patient Characteristics?

The phase 3 MATTERHORN trial is a global, randomized, double-blind, placebo-controlled study evaluating the efficacy of neoadjuvant-adjuvant durvalumab plus FLOT chemotherapy.

 The study’s primary end point is EFS; key secondary end points include OS and pathological complete response (pCR).

The study population consists of 948 patients with localized gastric/GEJ adenocarcinoma who were treatment-naive upon enrollment. Patients were enrolled from across Asia, Europe, North America, and South America; of note, according Tabernero, is that 20% of patients were from Asia. Patients were stratified by geographical region, clinical lymph node status, and PD-L1 expression.

For treatment, patients were randomly assigned 1:1 to receive either the durvalumab and FLOT combination or placebo plus FLOT (n = 474, both arms) in the neoadjuvant setting. Here, patients received their 1500 mg of their assigned treatment plus FLOT for 2 cycles before undergoing surgical resection 4 to 8 weeks after their last dose.

 Following surgical resection recovery, patients received 1500 mg of durvalumab or placebo as adjuvant therapy for up to 1 year.

What Trial Data Have Been Previously Reported?

In 2023, interim results with a data cutoff on February 1, 2023, suggested a significant and clinically meaningful benefit in pCR and near-PCR, with response rates of 27% and 14% observed in the investigational and control arms, respectively.

 Next, earlier in 2025, results of a primary end point analysis published in 

 revealed a 2-year EFS rate of 67.4% in the investigational arm vs 58.5% in the control arm.

 A consistent and manageable safety profile between arms was depicted in both reports.

Riding on the favorable efficacy and safety trends observed in previous analyses, this most recent readout highlights the potential of durvalumab and FLOT to become a new perioperative treatment option for patients.

Disclosures: Tabernero declared a consulting role with Accent Therapeutics, Alentis Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Carina Biotech, Cartography Biosciences, Chugai Pharmaceutical, Daiichi Sankyo Company, Eli Lilly and Company, F. Hoffmann-La Roche AG, Genentech, Johnson & Johnson, Menarini Ricerche S.p.A, Merus N.V., MSD, Novartis, Ono Pharma USA, Peptomyc, Pfizer, Pierre Fabre, Quantro Therapeutics, Scandion Oncology, Scorpion Therapeutics, Servier, Sotio Biotech, Taiho Pharmaceutical, Takeda Pharmaceutical International AG, and Tolremo Therapeutics, and stocks with 1 TRIAL SP, Alentis Therapeutics, Oniria Therapeutics and Pangaea Oncology.

Tabernero, J. Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric / gastroesophageal junction (G / GEJ) adenocarcinoma. Presented at: ESMO 2025 Congress; October 17–20, 2025; Berlin, Germany. Abstract LBA81.

Assessing durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer. ClinicalTrials.gov. Updated April 3, 2025. Accessed October 17, 2025. 

https://clinicaltrials.gov/study/NCT04592913

Janjigian YY, Van Cutsem E, Muro K, et al. MATTERHORN: phase III study of durvalumab plus FLOT chemotherapy in resectable gastric/gastroesophageal junction cancer. 

. 2022;18(20):2465-2473. doi:10.2217/fon-2022-0093

Janjigian YY, Al-Batran SE, Wainberg Za, et al. LBA73 Pathological complete response (pCR) to durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric and gastroesophageal junction cancer (GC/GEJC): Interim results of the global, phase III MATTERHORN study. 

. 2023;34:S1315-S1316. doi: 10.1016/j.annonc.2023.10.074

Janjigian YY, Al-Batran SE, Wainberg ZA, et al. Perioperative durvalumab in gastric and gastroesophageal junction cancer. 

. 2025;393(3):217-230. doi: 10.1056/nejmoa2503701

The phase 3 MATTERHORN trial demonstrated that durvalumab combined with FLOT chemotherapy significantly improved overall survival in patients with resectable gastric/gastroesophageal junction adenocarcinoma compared to placebo plus FLOT. This improvement was consistent across various subgroups, including PD-L1 status. The trial's primary endpoint, event-free survival, also showed favorable results. The study involved 948 treatment-naive patients globally, with a balanced distribution between the investigational and control arms. Previous interim results indicated significant benefits in pathological complete response rates, supporting durvalumab plus FLOT as a potential new standard of care.

Saruparib plus an androgen receptor pathway inhibitor was safe and active in metastatic prostate cancer.

Perioperative Durvalumab Plus FLOT Generates OS Benefit in Gastric/GEJ Adenocarcinoma

Atezolizumab and intravesical BCG in NMIBC: 

Atezolizumab (Tecentriq) in combination with BCG induction and maintenance therapy did not produce a significant benefit in terms of event-free survival (EFS) compared with BCG alone for the treatment of patients with BCG-naive, high-risk non–muscle invasive bladder cancer (NMIBC), according to findings from the phase 3 ALBAN trial (NCT03799835) presented during the 

The findings, presented by Morgan Roupret, MD, PhD, professor of urology at Sorbonne University in Paris, France, and simultaneously published in the 

, reported 73 events of 262 patients in the experimental combination arm vs 72 of 255 patients in the single-agent BCG arm. Events were defined as high-grade or low-grade NMIBC relapse, persistence of carcinoma in situ (CIS) after 6 months, progression of disease, appearance of upper tract urothelial carcinoma, or death of any cause. The HR for EFS was 0.98 (95% CI, 0.71–1.36; 

“You don’t have to be a statistician to see the [Kaplan-Meier] curves are very close to one another,” said Roupret during the presentation.

Regarding the secondary end point of high-grade recurrence-free survival (RFS), defined as reappearance of high-grade NMIBC or death of any cause, there was also no improvement in the experimental arm (HR, 1.06; 95% CI, 0.73–1.55; 

= .7658). Data were not yet mature for an analysis of overall survival (OS), but there was no impact on the median survival with the addition of atezolizumab (HR, 1.73; 95% CI, 0.73–3.92; 

Any-grade treatment-related adverse events (TRAEs) were reported in 94.1% (n = 240) and 75.6% (n = 189) of patients in the experimental and control arms, respectively. Grade ≥3 TRAEs and serious TRAEs occurred in 22.7% (n = 58) of patients in the atezolizumab arm and 8.8% (n = 22) of patients in the BCG-only arm and 23.5% (n = 60) and 8.4% (n = 21) of patients, respectively.

TRAEs leading to dose interruption were reported in 18.4% (n = 47) of patients in the experimental arm vs 7.6% (n = 9) in the control arm; TRAEs leading to withdrawal were reported in 28.6% (n = 73) and 8.8% (n = 22) of patients, respectively. In the experimental arm, 12.5% (n = 32) of patients withdrew from BCG only, 16.1% (n = 41) withdrew from atezolizumab only, and 3.1% (n = 8) withdrew from both.

“[Adverse events] that were depicted, rash and pruritus, were largely common and already depicted in the previous literature. There was no particular surprise,” Roupret said during the presentation.

ALBAN enrolled 517 patients who were BCG-naïve with high-risk NMIBC after first- and second-look transurethral resection of bladder tumor (TURBT). High-risk was defined as the presence of any high-grade/grade 3 Ta or T1 tumors and/or CIS. Patients were also required to have no metastatic disease in the pelvis, abdomen, or chest and an ECOG performance status of 0 to 2.

Patients were randomized 1:1 to receive BCG once a week for 6 weeks during the induction phase and once a week for 3 weeks at 3, 6, and 12 months during the maintenance phase with or without atezolizumab, which was administered at 1200 mg intravenously every 3 weeks for up to 1 year.

The primary end point was EFS, and key secondary end points included high-grade RFS, progression-free survival, OS, duration of response, safety, and quality of life.

Patient characteristics were balanced between the arms. The median age was 67.7 years (range, 36.0–88.0) in the combination arm vs 67.0 (range, 29.0–91.0) in the control arm. Male patients comprised 84.4% (n = 221) of the experimental arm and 86.7% (n = 221) of the control arm.

Roupret noted that the only potential discrepancy between arms was past history as a smoker. In the experimental arm, 66.0% (n = 173) of patients identified as a former smoker and 19.1% (n = 50) as a current smoker. In the control arm, these numbers were 61.8% (n = 157) and 15.0% (n = 38), respectively.

In his conclusion, Roupret said that future research would focus on biomarker-driven patient selection based on integrated molecular and spatial immune profiling. He also noted a need for optimization of the timing, duration, and delivery route of checkpoint inhibitors in NMIBC.

Disclosures: Roupret declared a consulting or advisory role with Johnson & Johnson, Ipsen, BMS, Astellas, Accord Healthcare, AAA, Ferring, Oncodiag, Intuitive, Medtronics, MSD, Pfizer, AstraZeneca, Bayer, Photocure, Provepharm, Thermofisher, Vitadx, Recordati, Besins Healthcare, CG Oncology, Curium, and Roche Genentech.

Atezolizumab combined with BCG therapy did not significantly improve event-free survival (EFS) compared to BCG alone in BCG-naive, high-risk non–muscle invasive bladder cancer (NMIBC) patients, as shown in the phase 3 ALBAN trial. The trial reported similar high-grade recurrence-free survival (RFS) and no impact on median overall survival (OS) with the addition of atezolizumab. Safety findings indicated higher treatment-related adverse events in the combination arm. Future research will focus on biomarker-driven patient selection and optimizing checkpoint inhibitor administration in NMIBC.

Atezolizumab plus BCG did not extend EFS vs BCG alone in BCG-naive, high-risk non–muscle invasive bladder cancer.

Andrea Eleazar, MHS