In the phase III CheckMate-77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage 2A to 3B non-small cell lung cancer, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival as assessed by Blinded Independent Central Review compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
FDA has approved Keytruda (pembrolizumab) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer.
The European Commission approved Keytruda (pembrolizumab) as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
FDA approved Braftovi (encorafenib) with Mektovi (binimetinib) for adult patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test.
A novel study led by Friends of Cancer Research is providing evidence that tumor response rates can be assessed across real-world data sets, bringing regulators one step closer to potentially building a framework for pre-market evaluation of cancer drugs and post-market tracking of drug performance based on real-world endpoints.
The FDA Oncologic Drugs Advisory Committee concurred with the FDA staff that the Amgen Inc. confirmatory trial of the lung cancer therapy sotorasib (Lumakras) was uninterpretable as a result of a perceived loss of equipoise.
The phase III MARIPOSA study met is primary endpoint resulting in statistically significant and clinically meaningful improvement in progression-free survival for Rybrevant (amivantamab-vmjw) plus lazertinib versus osimertinib in patients with EGFR-Mutated non-small cell lung cancer.
FDA has granted Fast Track designation to Mythic’s investigational cMET-targeting ADC, MYTX-011, for the treatment of patients with non-small cell lung cancer with cMET overexpression.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Six-year results from part 1 of the phase III CheckMate -227 trial demonstrate long-term, durable survival benefits of Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in the first-line treatment of patients with metastatic non-small cell lung cancer, regardless of PD-L1 expression levels.
