All Oncology News

The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.

MRD Detection With Novel ctDNA Assay Helps Determine Distant Recurrence Risk in TNBC

December 12th 2025

MRD as detected by a novel tumor-informed ctDNA assay helped identify patients with TNBC who were at higher risk for distant recurrence after surgery.

TERN-701 Elicits Deep Responses in Heavily Pretreated CP-CML

December 12th 2025

TERN-701 yielded a high response rate with deep molecular responses in heavily pretreated chronic phase chronic myeloid leukemia.

EMA Recommends Approval of Nogapendekin Alfa Inbakicept Plus BCG for NMIBC With CIS

December 12th 2025

The EMA recommended conditional marketing authorization for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with CIS.

Phase 3 STAR-221 Study of First-Line Domvanalimab/Zimberelimab Plus Chemo in Upper GI Cancers to Be Discontinued

December 12th 2025

Both the phase 3 STAR-221 trial and phase 2 EDGE-Gastric studies of domvanalimab plus zimberelimab in upper GI cancers are being discontinued.

Gedatolisib Plus Fulvestrant ± Palbociclib Is a Potential New SOC in HR+ PIK3CA Wild-Type Advanced Breast Cancer

December 12th 2025

Gedatolisib regimens showed PFS benefits irrespective of prior treatment duration in HR-positive, HER2-negative PIK3CA wild-type advanced breast cancer.

Experts Spotlight ASH 2025 Data Poised to Change Treatment Paradigms in AML, MZL, and Myeloma

December 12th 2025

Experts reflect on pivotal data from the 2025 ASH Annual Meeting that are set to change practice in AML, MZL, FL, and multiple myeloma.

Long-Term PALLAS Data Show No Adjusted OS Difference With Adjuvant Palbociclib in HR+/HER2– Breast Cancer

December 12th 2025

An adjusted OS analysis showed no OS difference with the addition of adjuvant palbociclib in HR-positive/HER2-negative breast cancer.

Camizestrant Switch Plus CDK4/6 Inhibition Continues to Outperform SOC in HR+/HER2– Breast Cancer

December 12th 2025

Camizestrant plus continued CDK4/6 inhibition led to clinically meaningful improvements in PFS, PFS2, TTFST, TTSSS, and chemotherapy/ADC-free survival vs SOC.

Elacestrant-Based Combinations Show Efficacy, Safety in ER+, HER2-Negative Breast Cancer

December 12th 2025

Elacestrant plus abemaciclib or everolimus was safe and showed preliminary efficacy in ER-positive, HER2-negative advanced breast cancer.

Alpelisib Plus Fulvestrant Hits Primary PFS End Point in CDK4/6 Inhibitor–Pretreated, PIK3CA-Mutant, HR+/HER2– Breast Cancer

December 12th 2025

Alpelisib plus fulvestrant improved PFS vs fulvestrant alone in PIK3CA-mutated, hormone receptor–positive/HER2-negative advanced breast cancer.

CAPItello-291 Analysis Reveals Potential Utility of PIK3CA/AKT1/PTEN Alteration Detection Via ctDNA in Advanced HR+ Breast Cancer

December 11th 2025

Circulating tumor DNA could represent a minimally invasive approach for detecting AKT pathway alterations in hormone receptor–positive breast cancer.

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

December 11th 2025

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

Oral and Subcutaneous Azacitidine Show Comparable PK, Safety Profiles in MDS and CMML

December 11th 2025

Oral azacitidine demonstrated a similar pharmacokinetic and safety profile to the subcutaneous formulation in MDS or CMML.

Real-World Data Showcase Efficacy of Adjuvant Pembrolizumab in ccRCC

December 11th 2025

Pembrolizumab in the adjuvant setting yielded high DFS and OS results in addition to a manageable safety profile in real-world patients with ccRCC.

Resection of MRI-Detected Disease Fails to Improve Recurrence Rates in Early Breast Cancer

December 11th 2025

Locoregional recurrence-free rates were similar in newly diagnosed breast cancer, irrespective of resection of MRI-detected disease.

FDA Grants Priority Review to sBLA For Nivolumab Plus AVD in Untreated Classical Hodgkin Lymphoma

December 11th 2025

The FDA has accepted and granted priority review to the sBLA for nivolumab plus AVD in untreated adult and pediatric classical Hodgkin lymphoma.

Pembrolizumab Plus Radiation Yields Improvements in T-Cell Infiltration in Early Breast Cancer

December 11th 2025

Patients with early breast cancer who received pembrolizumab plus radiation therapy experienced significant improvements in T-Cell infiltration and promising pCR rates.

FDA Grants Orphan Drug Designation to Risvutatug Rezetecan for SCLC

December 11th 2025

The FDA granted orphan drug designation to the B7-H3–targeted antibody-drug conjugate GSK’227 for small cell lung cancer.

Belzutifan Maintains Efficacy After a PD-(L)1 Inhibitor and Multiple VEGFR TKIs in ccRCC

December 11th 2025

Belzutifan maintained efficacy benefits vs everolimus among patients with ccRCC after at least 2 prior VEGFR TKIs.

Race, Ethnicity and Donor Type Continue to Affect Survival After Donor Stem Cell Transplant

December 11th 2025

A study led by Roswell Park Comprehensive Cancer Center reveals that a patient’s race and ethnicity can affect clinical outcomes for stem cell transplant.