 in November 2021 as a senior editor and became the website's managing editor in October 2023. Before arriving at MJH Life Sciences, he spent nearly a decade covering professional and high school sports—including the New Jersey Devils and the NHL from 2016 to 2021—for The Star-Ledger and NJ.com. Email: chryan@onclive.com

Lisocabtagene maraleucel (Breyzani; liso-cel) significantly prolonged event-free survival (EFS) and progression-free survival and improved complete responses (CRs) compared with standard of care (SOC) when used in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma (LBCL), according to data from a prespecified interim analysis of the phase 3 TRANSFORM trial (NCT03575351).

Results, which will be presented at the 2021 ASH Annual Meeting, indicated that patients who received the CD19-directed CAR T-cell therapy (n = 92) experienced a median EFS of 10.1 months (95% CI, 6.1–not reached [NR]) vs 2.3 months (95% CI, 2.2-4.3) in those who received SOC treatment with salvage chemotherapy, followed by high-dose chemotherapy and autologous stem cell transplantation (ASCT; n = 92; HR, 0.349; 

Additionally, liso-cel resulted in a median PFS of 14.8 months (95% CI, 6.6–NR) vs 5.7 months (95% CI, 3.9-9.4) with SOC (HR, 0.406; 

 = .0001). The CAR T-cell therapy was also found to elicit a complete response (CR) rate of 66% (95% CI, 55.7%-75.8%) compared with 39% (95% CI, 29.1%-49.9%) with SOC (

“[We do not yet know what] this means for sequencing at this point in time; it is preliminary. We don't quite know what [comes] after CAR T-cell therapy,” lead study author Manali Kamdar, MD, clinical director of Lymphoma Services and associate professor in Medicine/Hematology at University of Colorado Medicine, told 

. “However, we do know that certain agents, other immunotherapy products, may come in handy and may be of value to patients who relapse after CAR T-cell therapy. [Regardless,] it is important to highlight that CAR T-cell therapy with liso-cel in the second-line setting really shows a paradigm shift compared [with] the SOC.”

Finding a second-line alternative to SOC for patients with relapsed/refractory LBCL is an unmet need for this patient population, according to Kamdar, as these patients may experience poor outcomes with standard practices. An autologous CD19-directed, defined composition, 4-1BB CAR T-cell product, liso-cel was designed to be administered at equal target doses of CD8- and CD4-positive CAR-positive T cells.

Previously, the agent was found to induce an objective response rate (ORR) of 73% in patients with relapsed/refractory LBCL who had received 2 or more prior lines of therapy, with a CR rate of 53%, according to data from the phase 1 TRANSCEND NHL 001 trial (NCT02631044).

 In the global, multicenter phase 3 TRANSFORM trial, investigators sought to explore the efficacy of liso-cel vs SOC in patients with LBCL who relapsed within 12 months, or who were refractory to first-line treatment.

To be eligible for enrollment, patients needed to be 75 years or younger, have an ECOG performance status of 0 or 1, and acceptable organ function. Moreover, patients needed to be eligible for ASCT. Notably, patients with secondary central nervous system lymphoma were permitted. If patients previously received gene or anti-CD19–targeted therapy, or had an active infection, they were excluded.

A total of 184 patients underwent randomization and 92 patients were enrolled to each treatment arm. Patients in arm A, the control arm of the trial, received investigator’s choice of SOC, starting with R-DHAP (rituximab [Rituxan] plus dexamethasone, high-dose cytarabine, and cisplatin), R-ICE (rituximab, plus ifosfamide, carboplatin, and etoposide) or R-GDP (rituximab plus gemcitabine, dexamethasone, and cisplatin) for 3 cycles. Those who achieved a CR or partial response (PR) to treatment, then proceeded to receive BEAM (carmustine, etoposide, cytarabine, and melphalan) and undergo ASCT.

Those in arm B underwent lymphodepletion with fludarabine and cyclophosphamide; this was followed by liso-cel, which was administered at a target dose of 100 x 106 CAR-positive T cells. Patients in this arm were permitted to receive bridging therapy with an arm A chemotherapy regimen.

Notably, those in arm A who did not achieve a CR or PR following 3 cycles of chemotherapy, did not achieve a CR after ASCT, or who experienced disease progression, were permitted to crossover to receive the CAR T-cell therapy.

The primary end point of the trial is EFS per independent review committee and Lugano 2014 criteria. Key secondary end points comprised CR rate, PFS, and overall survival (OS). The 

value significance threshold for end points to reject the null hypothesis was ≤ 0.012.

The median age of patients in arm A was 58 years (range, 26-75) vs 60 years (range, 20-74) in arm B. In the control arm, most patients were male (66%) and had an ECOG performance status of 0 (62%); in the investigative arm, 52% of patients were female and 52% had a status of 0. Across the arms, most patients had diffuse large B-cell lymphoma. In arm A, 74% had refractory disease and 26% had relapsed disease; in arm B, 73% had refractory disease and 27% had relapsed disease.

In arm A, 91 patients received treatment and 1 withdrew consent. After receiving SOC salvage chemotherapy, 43 patients went on to receive BEAM and ASCT; 28 of these patients achieved a CR to chemotherapy. A total of 50 patients in arm A crossed over to receive liso-cel. In arm B, 90 of 92 patients received liso-cel, and 58 patients received bridging therapy.

Additional data showed that patients who received liso-cel experienced a 6-month EFS rate of 63% (95% CI, 52.0%-74.7%) vs 33% (95% CI, 23.0%-43.8%) in those who received SOC. Moreover, the CAR T-cell product induced an ORR of 86% (95% CI, 77.0%-92.3%) vs 48% (95% CI, 37.3%-58.5%) with SOC.

Treatment-emergent adverse effects (TEAEs) of any grade occurred in 100% of patients in the liso-cel group compared with 99% of those in the SOC group. Ninety-two percent of patients in the liso-cel arm experienced a TEAE that was grade 3 or higher vs 87% of those in the SOC arm. The most comment nonhematologic TEAEs reported in the liso-cel and SOC arms were nausea (53% and 57%, respectively), fatigue (39% and 38%), and diarrhea (25% and 42%).

Furthermore, the most common cytopenias experienced in the investigative and control arms were neutropenia (82% and 54%, respectively), anemia (63% and 64%), thrombocytopenia 58% and 68%), lymphopenia (27% and 11%), febrile neutropenia (15% and 24%), and leukopenia (15% and 14%). Additionally, 15% of patients who received liso-cel and 21% of those who were given SOC reported an infection that was grade 3 or higher.

Two percent of patients who received SOC treatment experienced tumor lysis syndrome vs no patients who were infused with liso-cel.

Kamdar M, Solomon SR, Arnason JE, et al. Lisocabtagene maraleucel, a CD19-directed chimeric antigen reception T cell therapy, versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma: results from the randomized phase 3 transform study. Paper presented at 63rd ASH Annual Meeting; December 11, 2021; Atlanta, GA. Accessed November 22, 2021. 

Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study

. 2020;396(10254):839-852. doi:10.1016/S0140-6736(20)31366-0

Articles

Lisocabtagene maraleucel significantly prolonged event-free survival and progression-free survival and improved complete responses when used in the second-line treatment of patients with relapsed or refractory large B-cell lymphoma.

Liso-cel Significantly Prolongs EFS Over SOC in Second-Line Relapsed/Refractory LBCL

AGEN1181, a next-generation CTLA-4 inhibitor, exhibited clinical activity both as a monotherapy and in combination with balstilimab in heavily pretreated patients with advanced solid tumors, according to data from the phase 1/1b Agenus C-800-01 trial (NCT03860272) presented during the 

As of a data cutoff of September 17, 2021, 4 patients who received AGEN1181 as a single agent achieved a confirmed objective response to treatment; this included 1 complete response (CR) in a patient with microsatellite stable (MSS) endometrial cancer, and partial responses (PRs) in 1 patient with pancreatic cancer, 1 patient with PD-1–refractory cervical cancer, and 1 patient with PD-1–refractory melanoma. Notably, 3 of the responders expressed low affinity FcγRIIIA receptor, which has been linked with a lack of response to first-generation CTLA-4 inhibitors.

When given at a dose of at least 1 mg/kg and paired with balstilimab, more than 60% of evaluable patients achieved disease control. Specifically, among 20 evaluable patients with MSS colorectal cancer (CRC), 3 patients achieved PRs and 1 had an unconfirmed PR. Ten patients achieved stable disease, with 1 patient experiencing a 27% reduction in tumor burden. The disease control rate (DCR) among patients with MSS CRC was 70%.

Among 9 patients with ovarian cancer who received at least 1 mg/kg of AGEN1181 plus balstilimab, the DCR was 56%; 3 patients achieved PRs and 2 experienced stable disease, with 1 patient experiencing a 28% reduction in tumor burden. In 3 patients with MSS endometrial cancer who received monotherapy or lower combination dosing, the DCR was 100%, with 1 CR and 2 PRs reported.

“AGEN1181 as monotherapy and in combination with balstilimab has shown promising activity in patients with poorly immunogenic tumors such as MSS-CRC, endometrial, and ovarian cancers; these are tumor types that do not traditionally respond well to single agent anti PD-1/PD-L1 therapy,” Anthony El-Khoueiry, MD, director of the Phase I Program and associate professor of clinical medicine at Keck School of Medicine of University of Southern California, stated in a press release.

 “Importantly, multiple responders expressed the low affinity FcγRIIIA receptor, a feature that makes them less likely to respond to first-generation CTLA-4 antibodies. Together, this highlights the potential of AGEN1181 to fulfill unmet medical needs in the current treatment landscape by overcoming limitations of approved immunotherapies.”

AGEN1181 is an Fc-enhanced anti–CTLA-4 monoclonal antibody. Fc optimization permits coverage of all FcγRIIIA polymorphic variants and extends benefit by targeting patients who express the low-affinity allele while enhancing benefit for those with the high-affinity allele. The agent was designed to possess the following benefits: expand responses in poorly immunogenic tumor types, eliminate important contributors to immunotherapy resistance, produce durable antitumor immunity and disease control, and improve safety.

The trial enrolled a total of 116 patients with advanced solid tumors that were refractory to standard therapies. All patients had received at least 1 prior line of therapy. Previous treatment with PD-1 inhibitors was permitted.

In the dose-escalation portion of the trial, patients in the monotherapy cohort received AGEN1181 intravenously at doses of 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, 2.0 mg/kg, and 3.0 mg/kg every 3 weeks or at 1.0 mg/kg or 2.0 mg/kg every 6 weeks. Those in the combination cohort received AGEN1181 intravenously at 0.1 mg/kg, 0.3 mg/kg, 1.0 mg/kg, or 2.0 mg/kg every 6 weeks in combination with intravenous balstilimab at 3 mg/kg every 2 weeks. In the dose-expansion portion of the trial, AGEN1181 was given at doses of 1.0 mg/kg or 2.0 mg/kg every 5 weeks plus balstilimab at 3 mg/kg every 2 weeks.

Notably, crossover to the combination arm was allowed.

The median age of study participants was 62 years (range, 28-82) and 64.7% of patients had an ECOG performance status of 1. Moreover, 28.4% of patients had CRC, 12.9% had ovarian cancer, 6.0% had hepatocellular carcinoma, 6.0% had angiosarcoma, 5.2% had pancreatic cancer, and 41.4% had a tumor classified as other. Notably, 58.6% of patients (n = 68) received 3 or more previous lines of therapy, and 31.0% of patients previously received treatment with a PD-1 or PD-L1 inhibitor.

Ultimately, 44 patients received AGEN1181 monotherapy and 85 patients received the agent in combination with balstilimab.

Pharmacologic data indicated that serum AGEN1181 terminal elimination half-life was 13.4 days, and clearance of the agent appears to be independent of dose, duration of treatment, dosing frequency, or co-administration with balstilimab. Moreover, AGEN1181 and balstilimab antidrug antibody frequency was low (3%) and there was no evidence of effect on drug exposure.

Beyond the clinical activity shown in both the AGEN1181 monotherapy and combination AGEN1181/balstilimab arms, El-Khoueiry said the drug performed consistently with its design to improve safety, compared with previous CTLA-4 inhibitors.

The maximum tolerated dose had not been reached in either the monotherapy or combination dosing cohorts. Across monotherapy and combination cohorts, 97.4% of patients (n = 113/116) experienced at least 1 treatment-emergent adverse effect (AE). Additionally, 55.2% of patients reported a serious AE with treatment, and 80.2% experienced a treatment-related AE. Furthermore, 61.2% of patients experienced a grade 3 to 5 TEAE, 48.3% had a grade 3 to 5 serious AE, and 20.7% experienced a grade 3 to 5 TRAE.

Among those who experienced grade 3 or higher TRAEs, the most common toxicities included fatigue (2.9%) followed by acute kidney injury, anemia, bicytopenia, confusional state, decreased appetite, dehydration, enterocolitis infection, hypotension, infusion-related reactions, large intestinal perforation, lymphocyte count decreased, nausea, stomatitis, and vomiting (1.0% each). Two grade 5 treatment-related toxicities were reported; these included intestinal perforation that was not surgically treated and chronic colitis.

The most common immune-related toxicities included diarrhea/colitis (any grade, 42.2%; grade 3 to 5, 10.8%), alanine aminotransferase increased (any grade, 3.9%), aspartate aminotransferase increased (any grade, 3.9%), rash (any grade, 23.5%; grade 3 to 5, 2.0%), adrenal insufficiency (any grade, 2.0%), hypothyroidism (any grade, 4.9%), and hyperthyroidism (any grade, 2.9%). Notably, no immune-related hypophysitis, pneumonia, or high-grade hepatitis were reported.

Sixteen percent of patients discontinued treatment due to toxicity; 12% did so because of diarrhea or colitis. Moreover, 31% of patients received 40 mg/kg or more of prednisone equivalent to daily treatment, with 92% of cases due to diarrhea.

"Consistent with its design, safety is favorable compared to the class," El-Khoueiry concluded. "Pivotal phase 2 programs are underway in MSS colorectal cancer, endometrial and ovarian cancer, and melanoma."

El-Khoueiry A, Bullock A, Tsimberidou A, et al. 479 AGEN1181, an Fc-enhanced anti-CTLA-4 antibody, alone and in combination with balstilimab (anti-PD-1) in patients with advanced solid tumors: phase 1 results. 

. 2021;9. doi:10.1136/jitc-2021-SITC2021.479

Clinical activity of AGEN1181 demonstrated across 9 treatment-resistant cancers at SITC. News release. Agenus Inc.; November 12, 2021. Accessed November 23, 2021. https://bit.ly/3cIVJg4

AGEN1181, a next-generation CTLA-4 inhibitor, exhibited clinical activity both as a monotherapy and in combination with balstilimab in heavily pretreated patients with advanced solid tumors. 

CTLA-4 Inhibitor AGEN1181 Shows Early Activity in Heavily Pretreated Advanced Solid Tumors

The combination of eftilagimod alpha and paclitaxel produced a modest increase in median overall survival (OS) in patients with endocrine-resistant hormone receptor (HR)–positive/HER2-negative metastatic breast cancer; though, the effects were significant in patients younger than 65 years old, had low monocytes, or had more aggressive disease (luminal B), according to a post hoc analysis of the phase 2b IMP321-P011 trial (NCT02614833) that was presented during the 2021 SITC Annual Meeting.

Overall, data showed that the median OS was 20.4 months (95% CI, 14.3-25.1) in patients receiving the combination vs 17.5 months (95% CI, 12.9-21.9) in those who received placebo (HR, 0.88; 95% CI, 0.64-1.19; 

 < .197). However, in the subsets of younger patients, those with low monocytes (<0.25/nl), or those with luminal B disease, the median OS improved between 4.2 months and 19.6 months.

Specifically, in the patients under the age of 65 receiving eftilagimod alpha, the median OS was 22.3 months (95% CI, 15.3-29.6) compared with 14.8 months (95% CI, 10.9-18.5) for those in the placebo group (HR, 0.66; 95% CI, 0.45-0.97; 

Patients with low monocytes who received eftilagimod alpha/paclitaxel had a median OS of 32.5 months (95% CI, 18.2-NA) vs 12.9 months (95% CI; 7.5-120.4) for patients with low monocytes in the placebo group (HR, 0.44; 95% CI, 0.22-0.88; 

Furthermore, the median OS in patients with luminal B who received eftilagimod alpha/paclitaxel was 16.8 months (95% CI, 9.9-24.9) vs 12.6 months (95% CI; 10.2-17.3) for patients in the placebo arm (HR, 0.67; 95% CI, 0.41-1.08; 

"Additional toxicity by eftilagimod alpha was rare, [which was] mainly local injection site reactions, and the quality of life was higher at 6 months in the eftilagimod alpha arm compared to the placebo arm,” lead study author Hans Wildiers, MD, PhD, head of clinic and professor at UZ Leuven in Leuven, Belgium, said in a poster presentation of the data. “The combination of weekly paclitaxel and eftilagimod alpha requires further investigation in metastatic breast cancer.”

Eftilagimod alpha, a soluble LAG-3 protein, binds to a subset of major histocompatibility complex class 2 molecules and mediates activation of antigen-presenting cells (APCs) and CD8 T cells. The study examined its effects when combined with paclitaxel, a standard-of-care chemotherapy regimen after the failure of endocrine-based therapy.

In the trial, 227 patients were randomized 1:1 to receive eftilagimod alpha (n = 114) or placebo/paclitaxel (n = 113). All patients had HR-positive/HER2-negative metastatic breast cancer, with 49.1% classified as luminal B, 35.5% as luminal A, and 15.4% as other. Patients in the trial were heavily pretreated, with a median of 2 prior systemic anticancer regimens. The majority of patients were endocrine resistant (84%), and nearly half were pretreated with CDK4/6 inhibitors (44.2%). Furthermore, 74.8% of patients underwent palliative therapy. The median age was 60 years (range, 24-87).

Patients in both arms received paclitaxel at 80 mg/m2 on days 1, 8, and 15, followed by eftilagimod alpha at 30 mg or placebo on days 2 and 16 for up to 24 weeks. Next, patients entered a 48-week maintenance phase, where they received eftilagimod alpha or placebo every 4 weeks.

Except for 1 patient in the placebo group, all patients received at least 1 dose of medication and were included in the full analysis. In the eftilagimod alpha–arm, 58 patients (50.8%) completed all 6 cycles of chemoimmunotherapy, and 60 patients (52.6%) started maintenance therapy. In the placebo group, 50 patients (44.6%) completed all 6 cycles of chemoimmunotherapy and 54 patients (48.2%) started maintenance therapy.

Regarding safety, most patients on eftilagimod alpha and placebo had at least 1 treatment-emergent adverse event (TEAE) at 99.1% and 100%, respectively; grade 3 or higher TEAEs occurred in 68.4% and 65.2% of patients, respectively. Fatal TEAEs occurred in 2 patients on eftilagimod alpha compared with 3 on placebo. An additional 6 patients discontinued on eftilagimod alpha due to a TEAE vs 7 patients of those who were on placebo. Three patients on eftilagimod alpha discontinued due to hypersensitivity reactions developed following injections; paclitaxel-induced hypersensitivity induced this in 4 patients.

Injection-related reactions, all of which were between grades 1 and 3, were the most common TEAE related to eftilagimod alpha, which occurred in 65.8% of patients vs 11.6% on placebo.

Wildiers H, Armstrong A, Cuypere E, et al. Final results from AIPAC: a phase IIb trial comparing eftilagimod alpha (soluble LAG-3 protein) in combination with weekly paclitaxel in HR+ HER2- MBC. Presented at: 2021 SITC Annual Meeting; November 10-14, 2021; Washington DC. Abstract 948. 

http://dx.doi.org/10.1136/jitc-2021-SITC2021.948

The combination of eftilagimod alpha and paclitaxel produced a modest increase in median overall survival in patients with endocrine-resistant hormone receptor–positive/HER2-negative metastatic breast cancer. Though, the effects were significant in patients younger than 65 years old, had low monocytes, or had more aggressive disease.

Eftilagimod Alpha/Paclitaxel Combo Shows Improved OS in Metastatic HR+ Breast Cancer Subsets

The administration of trilaciclib (Cosela) prior to chemotherapy reduced chemotherapy-induced myelosuppression (CIM) and the need for associated supportive care in patients with extensive-stage small cell lung cancer (ES-SCLC), according to data from 3 phase 2 trials (NCT02499770; NCT03041311; NCT02514447) published in 

Results showed that the administration of trilaciclib before chemotherapy significantly improved the incidence and duration of severe neutropenia (SN), defined as an absolute neutrophil count of less than 0.5 × 10⁹ cells/L, in cycle 1. Specifically, 11.4% of patients (n = 14) who received trilaciclib experienced SN vs 52.9% of those (n = 63) who received placebo (adjusted relative risk [aRR], 0.206; 95% CI, 0.120-0.351;

< .0001). The mean duration of SN was 0 days with trilaciclib compared with 4 days with placebo (

Fewer patients who received trilaciclib required granulocyte colony-stimulating factors (G-CSFs) compared with those who were given placebo, at 28.5% and 56.3%, respectively (aRR, 0.509; 95% CI, 0.371-0.700; 

< .0001). Moreover, 3.3% of patients receiving trilaciclib needed erythropoiesis-stimulating agents (ESAs) vs 11.8% of those receiving placebo (

= .0254); 14.6% and 26.1% of patients, respectively, required red blood cell (RBC) transfusions 

“Compared with placebo, trilaciclib consistently reduced the duration and occurrence of SN, regardless of G-CSF administration. This translated into a reduction in G-CSF administration compared with placebo,” lead study author Renata Ferrarotto, MD, of The University of Texas MD Anderson Cancer Center, wrote. “Trilaciclib also consistently reduced the occurrence of chemotherapy-induced anemia, which was reflected in the reduction of RBC transfusions on/after week 5 and ESA use. By improving key myelosuppressive end points and reducing the need for associated supportive care, trilaciclib has the potential to reduce both the societal and economic burden of CIM.”

Standard-of-care (SOC) approaches for patients with ES-SCLC, such as carboplatin plus etoposide (E/P), E/P plus atezolizumab (Tecentriq), E/P plus durvalumab (Imfinzi), and second-line lurbinectedin (Zepzelca) and topotecan are all known to result in significant CIM.

Chemotherapy dose delays and/or reductions can be used to manage CIM, as well as supportive care comprised of granulocyte-colony stimulating factors (G-CSFs), erythropoiesis-stimulating agents (ESAs), and RBC and platelet transfusions. However, delays and modifications can negatively impact the efficacy of treatment. More interventions are needed to reduce the incidence of CIN.

The CDK4/6 inhibitor trilaciclib has emerged as an option that can reduce the incidence of CIM, and the agent has been examined in the following 3 randomized, double-blind, placebo-controlled trials: G1T28-05, G1T28-02, and G1T28-03. For the analysis published in 

, investigators pooled findings from all 3 trials to examine the use of G-CSFs, ESAs, and RBC transfusions, and to evaluate the relationship between supportive care interventions and the myeloprotective benefits of the agent.

Patients included on the trials were at least 18 years of age, had confirmed ES-SCLC, measurable disease per RECIST v1.1 criteria, an ECOG performance status of 0 to 2, and acceptable organ function.

G1T28-05 enrolled patients with newly diagnosed ES-SCLC. Patients were given intravenous (IV) trilaciclib at a dose of 240 mg/m2 or placebo, before chemotherapy on days 1 to 3 of each 21-day cycle for up to 4 cycles; this was followed by maintenance treatment with single-agent atezolizumab.

G1T28-02 also enrolled newly diagnosed patients with ES-SCLC. Here, patients received IV trilaciclib at 240 mg/m2 or placebo before chemotherapy on days 1 to 3 of each 21-day cycle. G1T28-03 included those with previously treated ES-SCLC, who received IV trilaciclib at 240 mg/m2 or placebo before IV topotecan at 1.5 mg/m2 on days 1 to 5 of each 21-day cycle.

In the trials, administration of ESAs and primary prophylaxis with G-CSFs was prohibited in cycle 1; however, therapeutic G-CSF was permitted. In cycle 2 and beyond, ESAs and G-CSFs were allowed per standard guidelines. RBC and platelet transfusions were permitted throughout the trials, per investigator discretion.

Key end points included duration of SN in cycle 1, occurrences of SN, G-CSF administration, grade 3 or 4 anemia, ESA administration, and occurrence and number of RBC transfusion on, or after, week 5.

A total of 242 patients were included in the pooled datasets; 123 received trilaciclib and 119 received placebo. Baseline and disease characteristics were noted to be comparable between the treatment arms. However, slightly more male patients and current smokers were noted in the investigative arm vs the control arm.

Additional data from the analysis showed that fewer patients who received trilaciclib (20.3%) experienced grade 3 or 4 anemia vs those who were given placebo (31.9%; aRR, 0.620; 95% CI, 0.405-0.949; 

Moreover, the proportion of patients requiring RBC transfusions due to anemia was consistently lower in the trilaciclib arm vs the placebo arm. The rate of RBC transfusions in the placebo arm rose from 8.4% in cycle 1 to 14.3% in cycle 4, whereas the proportion of those on the investigative arm who required RBC transfusions remained relatively stable.

In addition to attempting to improve quality of life for patients with ES-SCLC by reducing the need for supportive care interventions, the study authors pointed to the economic burden such treatments can have on patients. In the paper, they cited an analysis of almost 350 patients with SCLC. Results had indicated that 49% of the patients received G-CSFs, 43% received RBC transfusions, and 4% received ESAs. Incremental annual costs per patient with grade 3/4 hematologic adverse effects were $63,245 for neutropenia and $28,152 for anemia.

“Together with the results from the current analysis, these data suggest that administering trilaciclib prior to chemotherapy has the potential to reduce the burden of CIM on healthcare systems by reducing the use of supportive care measures and CIM-related hospital admissions,” the study authors concluded.

Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: pooled analysis of three randomized phase 2 trials. 

. 2021;10(17);5748-5756. doi:10.1002/cam4.4089

Epstein RS, Krenitsky J, Weerasinghe RK, et al. Real-world burden of myelosuppression in patients with small cell lung cancer (SCLC): retrospective, longitudinal data analysis. 

. 2020;38(suppl 15):e19300. doi:10.1200/JCO.2020.38.15_suppl.e19300

The administration of trilaciclib prior to chemotherapy reduced chemotherapy-induced myelosuppression and the need for associated supportive care in patients with extensive-stage small cell lung cancer. 

Chris Ryan

Articles

Liso-cel Significantly Prolongs EFS Over SOC in Second-Line Relapsed/Refractory LBCL

CTLA-4 Inhibitor AGEN1181 Shows Early Activity in Heavily Pretreated Advanced Solid Tumors

Eftilagimod Alpha/Paclitaxel Combo Shows Improved OS in Metastatic HR+ Breast Cancer Subsets

Trilaciclib Possesses Potential to Reduce Burden of Chemotherapy-Induced Myelosuppression in ES-SCLC