Non-Small Cell Lung Cancer (NSCLC)

LIBRETTO-432: Adjuvant Selpercatinib Reduces Recurrence Risk by 83% in RET Fusion-Positive Early-Stage NSCLC

The phase III LIBRETTO-432 trial demonstrated that adjuvant treatment with the selective RET inhibitor selpercatinib significantly reduced the risk of disease recurrence, progression, or death among patients with resected stage IB to IIIA RET fusion–...

Latest News

HARMONi-6: Ivonescimab Improves Overall Survival in Frontline Squamous NSCLC at ASCO 2026 Plenary

Ivonescimab, the first PD-1/VEGF bispecific antibody, demonstrated improved overall survival outcomes in previously untreated squamous non-small cell lung cancer (NSCLC) patients, delivering what investigators are calling a landmark advancement for this challenging patient population at the ASCO 2026 Plenary Session. Clinical Takeaway The HARMONi-6 trial represents a pivotal moment in squamous NSCLC treatment, with ivonescimab […]

Setidegrasib Demonstrates Early Activity in KRAS G12D–Mutated NSCLC

The KRAS G12D-targeted protein degrader setidegrasib demonstrated encouraging antitumor activity and a manageable safety profile in patients with KRAS G12D-mutant non-small cell lung cancer (NSCLC), according to phase 1 data presented at the 2026 European Lung Cancer Congress (ELCC) and published in The New England Journal of Medicine. Clinical Takeaway Setidegrasib at the 600 mg […]

FDA Accepts Neladalkib NDA for TKI Pretreated ALK Positive NSCLC, Sets November PDUFA Date

FDA acceptance of neladalkib’s NDA marks a major regulatory milestone for patients with TKI-pretreated ALK-positive NSCLC. With activity against brain metastases, resistance mutations, and a differentiated ALK-selective design, neladalkib may address critical unmet needs in this difficult-to-treat population.

FDA Accepts NDA for Zipalertinib in EGFR Exon 20 Insertion–Mutated NSCLC

The FDA has accepted a New Drug Application (NDA) for zipalertinib, an oral EGFR tyrosine kinase inhibitor, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. The submission is based on Phase 2b data from the REZILIENT1 study, with a PDUFA target action […]

Zoldonrasib Shows Early Activity in KRAS G12D–Mutated NSCLC: Phase 1 Data from AACR 2026

Revolution Medicines recently announced updated Phase 1 data for zoldonrasib in patients with previously treated KRAS G12D-mutated non-small cell lung cancer (NSCLC), presented at the AACR Annual Meeting 2026. As a selective inhibitor targeting one of the most historically “undruggable” KRAS mutations, these early findings provide an initial look at safety and early antitumor activity […]

A Matter of Timing: Earlier Immunochemotherapy Delivers Better Survival in NSCLC

Early time-of-day administration of immunochemotherapy significantly improved progression-free and overall survival in advanced NSCLC compared with later dosing. Benefits were accompanied by higher response rates and enhanced CD8⁺ T-cell activity, without added toxicity, highlighting a simple, cost-neutral strategy to optimize treatment outcomes.

FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for HER2-Mutant NSCLC, Showing 76% Response Rate in First-Line Setting

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zongertinib (Hernexeos) for adults with unresectable or metastatic non-squamous non–small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations as detected by an FDA-authorized test. Approval was based on clinical trial data demonstrating a 76% objective response rate in […]

ARROS-1 Trial: Zidesamtinib Demonstrates Activity in TKI-Pretreated ROS1-Positive NSCLC

Nuvalent announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for zidesamtinib for the treatment of adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) who have received at least one prior ROS1 tyrosine kinase inhibitor (TKI). The application is supported by data from the […]