Biomarker-Driven Lung Cancer

Nuvalent has submitted an NDA to the FDA for neladalkib, a brain-penetrant ALK-selective TKI for pretreated advanced ALK-positive NSCLC.

Phase 1 data show that setidegrasib degrades KRAS G12D, delivering durable NSCLC responses with manageable safety and biomarker-linked benefit as phase 3 plans advance.

FDA approves monthly subcutaneous amivantamab plus lazertinib for EGFR-mutated advanced NSCLC, cutting clinic time and infusion reactions while maintaining efficacy.

Adjuvant selpercatinib boosts event-free survival after surgery in early-stage RET fusion–positive NSCLC, signaling a potential new standard and expanding genomic testing.

A recent study reveals significant progress in biomarker testing for lung cancer in community settings, highlighting the need for improved access to targeted therapies.

Alectinib shows remarkable 4-year survival rates in early-stage ALK-positive lung cancer, outperforming chemotherapy in disease-free survival and CNS recurrence.

Treatment strategies for non–small cell lung cancer are increasingly driven by biomarker testing, making rapid and reliable biopsy an area that has attracted new interest among lung cancer specialists.

Experts explore advancements in bronchoscopic biopsies for lung cancer, emphasizing safety, sample adequacy, and the importance of rapid biomarker testing.

New clinical data reveals promising efficacy of VS-7375, a KRAS G12D inhibitor, in advanced lung cancer, highlighting its potential for unmet medical needs.

A multidisciplinary expert panel issued recommendations on the use of bronchoscopic biopsies in terms of safety and sample adequacy for comprehensive biomarker testing.

During a live event, Christine Bestvina, MD, discussed trials of KRAS inhibitors plus immunotherapy in patients with non–small cell lung cancer.

During a live event, Christine Bestvina, MD, reviewed outcomes from the phase 3 KRYSTAL-12 and CodeBreak 200 trials in the KRAS-mutated non–small cell lung cancer population.

The ALNEO trial's final analysis shows neoadjuvant alectinib is effective and well tolerated in resectable stage III ALK-positive NSCLC, achieving 42% MPR and 67% ORR, suggesting a feasible perioperative option.

The SACHI trial showed savolitinib + osimertinib significantly improved PFS (8.2 vs 4.5 months) vs chemotherapy in EGFR-mutated, MET-amplified advanced NSCLC after EGFR TKI progression.

Sevabertinib demonstrated high and durable objective response rates in pretreated and treatment-naive HER2-mutant NSCLC, with a manageable safety profile.

Adagrasib plus pembrolizumab improved efficacy in KRAS G12C-mutant NSCLC, according to data from the KRYSTAL-7 trial.

This priority review designation for sevabertinib in previously treated HER2-mutant non–small cell lung cancer is supported by data from the phase 1/2 SOHO-01 study.

Adagrasib shows initial promise, tolerability, and encouraging response rates in STK11/KRAS G12C-mutant lung cancer.

Phase 1b Beamion LUNG-1 trial data at AACR 2025 showed zongertinib yielded responses in pretreated HER2-mutant NSCLC, including TKD and non-TKD mutations.

The FDA is evaluating a new drug application for taletrectinib in patients with ROS1 fusion–positive non–small cell lung cancer.

The TKI zongertinib is currently being reviewed by the FDA for a potential approval for patients with HER2 mutation–positive non–small cell lung cancer.

During a Case-Based Roundtable® event, Vamsidhar Velcheti, MD, discussed the TRIDENT-1 trial and practical considerations for repotrectinib in non–small cell lung cancer.

Pending phase 3 trial results, a biologics license application will be submitted for the KRAS-targeting cancer vaccine ELI-002.

In separate, live virtual events, Vincent K. Lam, MD, and Chul Kim, MD, MPH, discuss molecular assays and treatment options for a patient with metastatic non–small cell lung cancer (NSCLC), with participants.

BBO-8520, an investigational oral agent, has been granted fast track designation from the FDA in previously treated KRAS G12C–mutated metastatic non–small cell lung cancer.