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.

Infinatamab Deruxtecan Shows Encouraging CNS Activity in Extensive-Stage Small Cell Lung Cancer

October 19th 2025

I-DXd showed intracranial efficacy and manageable safety in ES-SCLC with brain metastases, per data from the IDeate-Lung01 study.

Pembrolizumab/Lenvatinib Combo Is Active, Safe in Uveal Melanoma

October 19th 2025

Pembrolizumab plus lenvatinib was safe and active in HLA-A*02:01–negative and –positive uveal melanoma.

Gedatolisib Plus Fulvestrant ± Palbociclib Drives PFS Improvement in PIK3CA Wild-Type, HR+/HER2– Advanced Breast Cancer

October 19th 2025

Gedatolisib plus fulvestrant, with or without palbociclib, improved PFS in pretreated, HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.

Sac-TMT Yields PFS Benefit Over Chemotherapy in Pretreated HR+, HER2– Metastatic Breast Cancer

October 19th 2025

Sac-TMT bested chemotherapy in terms of PFS in previously treated HR+, HER2– metastatic breast cancer.

Perioperative Enfortumab Vedotin Plus Pembrolizumab May Represent New SOC in Cisplatin-Ineligible MIBC

October 18th 2025

Enfortumab vedotin plus pembrolizumab significantly improved survival and pCR vs surgery alone in cisplatin-ineligible MIBC per KEYNOTE-905 data.

Neoadjuvant T-DXd Plus THP Yields pCR Benefit in High-Risk, HER2+ Early-Stage Breast Cancer

October 18th 2025

Neoadjuvant T-DXd followed by THP improved pathological complete response rate in high-risk, HER2-positive early-stage breast cancer.

Consolidation Tiragolumab/Atezolizumab Does Not Yield PFS Advantage in Stage III NSCLC

October 18th 2025

The SKYSCRAPER-03 trial missed the end point of a PFS benefit with tiragolumab plus atezolizumab vs durvalumab consolidation in advanced NSCLC.

Pembrolizumab Plus Paclitaxel +/– Bevacizumab Yields Survival Advantages in Recurrent PROC

October 18th 2025

Pembrolizumab and paclitaxel with or without bevacizumab led to PFS and OS benefits vs placebo in place of pembrolizumab in recurrent, PD-L1–positive PROC.

Tarlatamab Improves OS vs Chemotherapy in SCLC, Regardless of Prior PD-(L)1 Therapy or CFI Duration

October 18th 2025

Findigs from DeLLphi-304 support the use of tarlatamab as a standard of care for all patients with second-line small cell lung cancer.

Invikafusp Alfa Boasts High Disease Control Rate in Checkpoint Inhibitor–Resistant Solid Tumors

October 18th 2025

Invikafusp alfa demonstrated early signals of antitumor activity across a range of biomarker-enriched patients with solid tumors.

Adjuvant Nivolumab Displays Long-Term Activity in Resected Melanoma

October 18th 2025

Adjuvant nivolumab significantly extended RFS vs ipilimumab in patients with resected stage IIIB to IIIC or IV melanoma.

T-DXd Improves IDFS and DFS vs T-DM1 in HER2+ Breast Cancer With Residual Invasive Disease

October 18th 2025

T-DXd significantly improved IDFS vs T-DM1 in high-risk, HER2-positive primary breast cancer with residual invasive disease after neoadjuvant therapy.

Incidence of Second Primary Tumors Is Similar Between Adjuvant Cemiplimab and Placebo in High-Risk CSCC

October 18th 2025

Adjuvant cemiplimab and placebo were associated with similar rates of second primary tumors in high-risk CSCC.

177-Lu-edotretide Prolongs PFS Compared With Everolimus in Grade 1/2 GEP-NETs

October 18th 2025

177-Lu-edotretide significantly improved survival outcomes vs everolimus for the treatment of patients with grade 1/2 GEP-NETs.

Phase 2 BNT111/Cemiplimab Data Prove Positive in PD-(L)1-Relapsed/Refractory Melanoma

October 18th 2025

BNT111 plus cemiplimab achieved an 18.1% ORR in PD-(L)1–refractory melanoma, meeting its primary end point in the phase 2 BNT111-01 trial.

First-Line Tarlatamab/Chemoimmunotherapy Yields Early Efficacy Signals in ES-SCLC

October 18th 2025

First-line treatment with tarlatamab plus chemoimmunotherapy and anti–PD-L1 maintenance therapy generated durable responses in patients with ES-SCLC.

Dato-DXd Plus Rilvegostomig Elicits Activity in Cisplatin-Ineligible or Platinum-Pretreated Urothelial Cancer

October 18th 2025

Datopotamab deruxtecan plus rilvegostomig was active in cisplatin-ineligible and platinum-pretreated locally advanced or metastatic urothelial cancer.

Lenvatinib Plus Everolimus Yields PFS Benefit in Previously Treated Advanced Clear Cell RCC

October 18th 2025

Lenvatinib plus everolimus improved PFS vs cabozantinib in metastatic clear cell renal cell carcinoma after progression on a PD-1 inhibitor.

Giredestrant/Everolimus Extends PFS for ER+, HER2– Advanced Breast Cancer

October 18th 2025

Giredestrant plus everolimus improved progression-free survival in ER-positive, HER2-negative advanced breast cancer after a prior CDK4/6 inhibitor.

Belzutifan Plus Pembrolizumab and Lenvatinib Demonstrates Potential in Advanced Clear Cell RCC

October 18th 2025

Belzutifan plus pembrolizumab and lenvatinib improved efficacy outcomes compared with multiple other pembrolizumab-based triplet regimens in advanced clear cell renal cell carcinoma.