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.

Firmonertinib Demonstrates Antitumor Activity, CNS Responses in EGFR PACC–Mutated NSCLC

September 9th 2025

Firmonertinib was active and safe at both the 160-mg and 240-mg dose levels across a broad range of patients with NSCLC harboring EGFR PACC mutations.

Double-Dose Firmonertinib Showing Promising Activity in First-Line EGFR L858R–Mutated NSCLC

September 9th 2025

Firmonertinib led to responses with a tolerable safety profile in frontline EGFR L858R–mutated NSCLC.

NCCN Adds Dordaviprone to Clinical Practice Guidelines in H3K27M-Mutant Diffuse High-Grade Glioma

September 9th 2025

Dordaviprone was included as a category 2A single agent in the NCCN guidelines for recurrent or progressive H3K27M-mutant diffuse high-grade glioma.

FDA Provides Guidance on Registrational Path for Ozuriftamab Vedotin in Oropharyngeal Squamous Cell Carcinoma

September 9th 2025

The FDA has provided guidance on the design of a potential phase 3 trial evaluating the ADC ozuriftamab vedotin in OPSCC.

Pooled Analysis Shows Manageable Safety Profile With Tepotinib in MET Exon 14+ NSCLC

September 9th 2025

Tepotinib treatment was characterized by frequent but manageable TRAEs in MET exon 14–positive NSCLC, with peripheral edema as the most common toxicity.

Yale Study: Potential Treatment Pathway Found for Rare and Aggressive Leukemia

September 9th 2025

A Yale study published identified the mechanism underlying the relationship between the development of AMKL and a specific genetic alteration that occurs.

SKYSCRAPER-05 Data Confirm Surgical Feasibility After Perioperative Tiragolumab Combo in NSCLC

September 9th 2025

The SKYSCRAPER-05 trial shed light on the use of perioperative tiragolumab plus atezolizumab with or without chemotherapy in NSCLC.

Tepotinib Generates Superior Responses in Adenocarcinoma vs Non-Adenocarcinoma MET Exon 14 Skipping NSCLC

September 8th 2025

Tepotinib showed superior outcomes in patients with adenocarcinoma MET exon 14 skipping NSCLC vs those with non-adenocarcinoma.

Final Analysis of Perioperative Tislelizumab Plus Chemotherapy Shows Sustained OS and EFS Improvement in Resectable NSCLC

September 8th 2025

Perioperative tislelizumab plus chemotherapy showed sustained OS and EFS improvement vs chemotherapy in resectable NSCLC.

ABBV-706 Yields Durable Responses and Is Deemed Tolerable in R/R SCLC

September 8th 2025

The SEZ6-targeting ADC ABBV-706 generated durable efficacy outcomes comparable with those of first-line SOC in patients with relapsed/refractory SCLC.

Signatera Genome Assay Demonstrates Strong Prognostic Value in Early-Stage Resectable NSCLC

September 8th 2025

A correlation between ctDNA negativity in the post-surgical MRD window and improved RFS and OS was observed with the Signatera Genome assay in NSCLC.

Dato-DXd Leads to Intracranial Responses in Advanced/Metastatic NSCLC With Brain Metastases

September 8th 2025

Dato-DXd demonstrated CNS PFS and ORR benefits vs docetaxel in patients with NSCLC with brain metastases.

Concurrent Durvalumab and Chemoradiotherapy Fails to Provide Survival Advantage in Unresectable, Stage III NSCLC

September 8th 2025

Durvalumab/chemoradiation followed by consolidation durvalumab did not improve OS vs chemoradiation followed by durvalumab in stage III NSCLC.

Taletrectinib Demonstrates Durable Responses in TKI-Naive and -Pretreated ROS1+ NSCLC

September 8th 2025

Taletrectinib delivered high response rates and durable benefit with manageable safety in ROS1-positive non–small cell lung cancer.

Neoadjuvant Darovasertib Produces Preliminary Responses in Uveal Melanoma

September 8th 2025

Darovasertib was safe and active in the neoadjuvant setting for patients with uveal melanoma.

Perioperative Pembrolizumab Plus Chemo Yields Improved Survival, Responses in Early-Stage Resectable NSCLC

September 8th 2025

Perioperative pembrolizumab demonstrated improved mPR, pCR, EFS, and OS in patients with early-stage resectable NSCLC and any nodal status.

Adjuvant Nivolumab Plus Chemo Decreases Disease Relapse Rates vs Chemo in Resected NSCLC

September 8th 2025

Adjuvant nivolumab plus chemotherapy led to a clinically meaningful reduction in relapse rates vs chemotherapy in resected NSCLC.

World Lung Cancer Expert Diagnosed with Advanced Lung Cancer

September 8th 2025

D. Ross Camidge, MD, PhD, has spent his career fighting lung cancer. In 2022, that fight turned personal when he received a diagnosis of his own.

Pirtobrutinib Monotherapy Meets Primary PFS End Point in Treatment-Naive CLL/SLL

September 8th 2025

Topline results from the BRUIN CLL-313 study show a significant improvement in PFS with pirtobrutinib vs chemoimmunotherapy in treatment-naive CLL/SLL.

New Genetic Biomarker Flags Aggressive Brain Tumors

September 8th 2025

A new study suggests that if a tumor shows activity in the TERT gene, it tends to recur more quickly, even if it looks low-grade under the microscope.