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.

The OncFive: Top Oncology Articles for the Week of 12/7

December 13th 2025

The FDA approved Akeega for use in BRCA2+ mCSPC, granted priority review to the sBLA for nivolumab plus AVD in classical Hodgkin lymphoma, and more.

RAD51-Based HRD Test Could Help Refine Patient Selection for Olaparib in BRCA1/2- or PALB2-Mutant, HER2– Breast Cancer

December 13th 2025

RAD51 may serve as a functional biomarker to help guide olaparib use in HER2-negative metastatic breast cancer harboring BRCA1/2 or PALB2 mutations.

Imlunestrant With/Without Abemaciclib Maintains PFS, OS Benefit in ER+/HER2– Breast Cancer

December 12th 2025

Imlunestrant alone or in combination with abemaciclib significantly improved PFS in ER-positive and HER2-negative breast cancer.

Neoadjuvant Niraparib Plus Dostarlimab Delivers 50% pCR Rate in BRCA+ or PALB2+ TNBC

December 12th 2025

Neoadjuvant niraparib plus dostarlimab led to pathologic complete responses in BRCA- or PALB2-mutated triple-negative breast cancer.

Giredestrant-Based Combo Boosts PFS Across Subgroups in Advanced ER+/HER2– Breast Cancer After CDK4/6 Inhibition

December 12th 2025

Giredestrant plus everolimus improved PFS across subgroups in ER-positive/HER2-negative advanced breast cancer.

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

December 12th 2025

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

FDA Approves Niraparib/Abiraterone Acetate Plus Prednisone for BRCA2+ mCSPC

December 12th 2025

The FDA has approved niraparib and abiraterone acetate with prednisone for BRCA2-mutated mCSPC.

Menopausal HRT Does Not Influence Breast Cancer Risk in Women Harboring BRCA Variants

December 12th 2025

Menopausal hormone replacement therapy was not associated with an increased risk of breast cancer in women with BRCA mutations.

Mayo Clinic Researchers Find New Hope for Toughest Myeloma Through Off-the-Shelf Immunotherapy

December 12th 2025

Dual-antibody, off-the-shelf therapy showed deep durable responses in patients with extra medullary multiple myeloma according to Mayo Clinic researchers.

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.