Non-Small Cell Lung Cancer (NSCLC)

Data from the phase 3 eXalt3 trial support the approval of ensartinib in adult patients with metastatic ALK-positive non–small cell lung cancer.

The phase 3 KeyVibe-003, KeyVibe-007, and KEYFORM-008 trials investigating vibostolimab and favezelimab have been discontinued.

These data support less restrictive clinical trial eligibility criteria for those with metastatic NSCLC. This is especially true regarding both targeted therapy and immunotherapy treatment regimens.

Zenocutuzumab is now approved for patients with NRG1 fusion-positive NSCLC or pancreatic adenocarcinoma.

For patients with EGFR-mutated non–small cell lung cancer, sacituzumab tirumotecan was given the breakthrough drug designation by the FDA.

Despite gaps in biomarker testing accessibility, the lung cancer survival rate has improved by 26% over the last 5 years.

Tiragolumab with atezolizumab, when compared with placebo with atezolizumab, failed to reach its overall survival end point in patients with NSCLC.

Results from the TRIDENT-1 and CARE trials, which showcased durable activity and robust responses with repotrectinib, supported the recommendation.

For patients with NSCLC, subcutaneous pembrolizumab appeared noninferior vs intravenous pembrolizumab for study end points when combined with chemotherapy.

FoundationOne Liquid CDx has been approved as a diagnostic tool for tepotinib in patients with non–small cell lung cancer METex14 skipping alterations.

Personalized therapy for non–small cell lung cancer has evolved significantly with the advent of comprehensive molecular testing.

Data from TROPION-Lung05, TROPION-Lung01, and TROPION-PanTumor01 support the new BLA for dato-DXd in advanced or metastatic EGFR-mutated NSCLC.

Treatment with THIO/cemiplimab was generally well-tolerated among patients with advanced NSCLC in the phase 2 THIO-101 study.

Glycan editing of cell surface glycans with E-602 may represent a novel therapeutic approach among patients with cancer.

Detection of S15 and PD-L1 proteins in more than half of NSCLC samples support the potential to target both pathways during treatment.

Updated OS findings from the PERLA trial showed continued success with dostarlimab plus chemotherapy in patients with advanced non–small cell lung cancer.

Treatment with domvanalimab/zimberelimab also improved progression-free survival vs platinum-based chemotherapy in the phase 3 ARC-10 study.

Patients with non–small cell lung cancer had a positive long-term benefit with perioperative chemoimmunotherapy, according to the 5-year NADIM trial update.

Data from the AcceleRET-Lung trial show an imbalanced risk of severe and fatal infection with pralsetinib for patients with RET fusion-positive NSCLC.

Phase 1 expansion data may support potential combination development for IDE397 in NSCLC and urothelial cancer harboring MTAP deletions.

Experts discussed the efficacy and durability of immunotherapy responses in patients with NSCLC.

A panel of experts focused on the use of dual immunotherapy options for patients with metastatic NSCLC without driver mutations.

Experts in non–small cell lung cancer met to debate the latest advances and treatment options and the hottest topics in the space.

Jenan Dailey, PharmD, BCAP, spoke about the approval of lazertinib plus amivantamab as first-line treatment for patients with locally advanced or metastatic NSCLC.

The agency places a partial clinical hold on the phase 3 PRESERVE-003 trial due to varying results between the squamous and nonsquamous NSCLC cohorts.