Boehringer Ingelheim breaks into oncology as FDA grants accelerated approval to Hernexeos (zongertinib) for HER2 TKD–mutated NSCLC

Boehringer Ingelheim; Hernexeos; zongertinib; FDA approval; accelerated approval; non-squamous NSCLC; HER2 TKD mutations; Oncomine Dx Target Test; Beamion LUNG-1; objective response rate; first oral targeted therapy for HER2-mutant NSCLC; priority review; breakthrough therapy designation; confirmatory trial requirement; competition with Enhertu

ImmuneOnco and Instil Bio’s PD-L1xVEGF Bispecific Antibody Shows Promising Results in Phase 2 Lung Cancer Trial

ImmuneOnco; Instil Bio; IMM2510/AXN-2510; PD-L1xVEGF bispecific antibody; NSCLC; Phase 2 clinical trial; response rate; safety profile; chemotherapy combination; lung cancer

AstraZeneca Highlights Survival Benefit for Tagrisso Combo Amid Competition in Lung Cancer

AstraZeneca; Tagrisso; lung cancer; Johnson & Johnson; EGFR-mutated NSCLC; overall survival; chemotherapy combination; FLAURA2 trial; life-extension benefit

Nuvalent Reports Positive Pivotal Data for ROS1-Targeted Lung Cancer Drug; Rolling FDA Submission Planned

Nuvalent; ROS1-positive lung cancer; zidesamtinib; FDA submission; ARROS-1 trial; NSCLC; tyrosine kinase inhibitor; objective response rate; brain metastases; oncology

Merck, Daiichi Sankyo Withdraw FDA Application for HER3-Targeting ADC After Survival Endpoint Miss

Merck; Daiichi Sankyo; patritumab deruxtecan; HER3 ADC; FDA application; non-small cell lung cancer; clinical trial; overall survival; application withdrawal

AbbVie Advances Solid Tumor Program with FDA Approval of Emrelis for Lung Cancer

AbbVie; Emrelis; FDA Approval; ADC; solid tumor; lung cancer; non-small cell lung cancer; c-Met overexpression; telisotuzumab vedotin-tllv; accelerated approval

‘Deviated from the core’: Akeso CEO tries to reset expectations of bispecific’s survival readout amid market tumult

Ivonescimab, PD-1xVEGF bispecific antibody, Overall survival (OS) readout, Keytruda head-to-head trial, HARMONi-2 trial, Non-small cell lung cancer (NSCLC), Market reaction, Summit Therapeutics