Non-Small Cell Lung Cancer (NSCLC)

Data from the SAMSON-II trial showed comparable PFS and OS outcomes with HD204 and reference bevacizumab among patients with nonsquamous NSCLC.

Treatment with sunvozertinib showed improvement across all secondary end points among those with EGFR exon 20 insertion mutation–positive NSCLC.

Although survival outcomes were comparable among the 3 PD-1 inhibitors in the overall cohort, tislelizumab and sintilimab showed superior PFS in PD-L1–positive subgroups, suggesting biomarker-driven therapeutic selection.

Based on an independent data monitoring committee’s feedback, enrollment for the phase 3 TACTI-004 trial will be halted.

Data from the REZILIENT1 trial support the NDA for zipalertinib for patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations.

The agency highlighted regulatory compliance issues associated with a third-party facility referenced in the application for retifanlimab.

Updated findings from the eNRGy trial bring “hope” for managing rare molecular subtypes in non–small cell lung cancer, said Zhaohui Liao Arter, MD.

The FDA approved zongertinib in HER2-mutated NSCLC as part of its Commissioner's National Priority Voucher pilot program.

The new living guideline contains updated recommendations for biomarker testing and therapeutic strategies based on factors such as PD-L1 expression status.

Monthly dosing of subcutaneous amivantamab may confer consistent outcomes with the previously approved biweekly dosing schedule in EGFR-mutant NSCLC.

Pranshu Mohindra, MD, outlined considerations for optimizing the use of hypofractionated radiation for patients with lung cancer.

Investigators will share detailed results from the phase 3 LIBRETTO-432 trial assessing selpercatinib in NSCLC at a future medical meeting.

Early data from the KYANITE-1 study support the RMAT designation for KB707 as a treatment for those with advanced or metastatic NSCLC.

Infusing chemoimmunotherapy earlier in the day also correlated with improvements in responses among patients with NSCLC in a phase 3 trial.

The FDA has assigned a Prescription Drug User Fee Act date of November 14, 2026, for the ivonescimab-based combination.

Data from a phase 2 study support metabolic response on PET/CT and ctDNA clearance as potential biomarkers for predicting event-free survival.

Data from the phase 2 FIRM study support the preliminary potential of firmonertinib as frontline therapy in EGFR L858R-mutated NSCLC.

Data from the phase 2 ALTER-L043 trial may support the viability of perioperative penpulimab-based treatment in resectable non–small cell lung cancer.

Data from the QUILT-3.055 and QUILT-2.023 studies support the accelerated approval of the nogapendekin alfa inbakicept regimens in Saudi Arabia.

Investigators will submit detailed results from the QUILT-2.023 and QUILT-3.055 trials for peer-reviewed publication and future scientific presentations.

Osimertinib plus chemotherapy improved overall survival across various subgroups in the phase 3 FLAURA2 trial, including those with CNS metastases.

Data from the phase 3 HARMONi trial support the application for the ivonescimab regimen in this EGFR-mutated NSCLC population.

Supporting data for zoldonrasib’s breakthrough therapy designation in NSCLC came from the phase 1 RMC-9805-001 trial.

Neoadjuvant immunotherapy plus chemotherapy did not definitively increase the risk of severe pneumonitis compared with adjuvant immunotherapy.

Patients with HER2-mutant NSCLC who were naïve to systemic therapy for advanced disease experienced positive results following treatment with sevabertinib.