Treatments in Trial: Lung Cancer Study Updates

Best Practices in Lung Cancer – November 2018 Vol 9 —November 29, 2018

FDA Grants Priority Review to Application for Pembrolizumab Monotherapy as First-Line Treatment of Locally Advanced or Metastatic Non–Small Cell Lung Cancer in Patients Whose Tumors Express PD-L1 (TPS ≥1%)

The FDA has granted priority review designation to a new supplemental Biologics License Application seeking approval for pembrolizumab, an anti–PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. The application is based on data from the pivotal phase 3 KEYNOTE-042 trial, 1 of 5 phase 3 clinical trials with pembrolizumab in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented at the 2018 American Society of Clinical Oncology Annual Meeting. The FDA has set a Prescription Drug User Fee Act, or target action, date of January 11, 2019.

Phase 3 CheckMate-331 Study Does Not Meet Primary End Point of Overall Survival with Nivolumab Versus Chemotherapy in Patients with Previously Treated Relapsed Small Cell Lung Cancer

Topline results were announced from the phase 3 CheckMate-331 study evaluating nivolumab versus the current standards of care, topotecan or amrubicin (where approved), in patients with small cell lung cancer (SCLC) who relapsed following platinum-based chemotherapy. The study did not meet its primary end point of overall survival with nivolumab versus chemotherapy. The safety profile of nivolumab in this trial was consistent with that observed in previously reported monotherapy studies involving patients with SCLC.

Sabine Maier, MD, development lead, thoracic cancers, Bristol-Myers Squibb, commented, “Small cell lung cancer is a highly aggressive disease in which significant unmet need remains. We are focused on researching innovative oncology therapies to improve outcomes for patients with lung cancer. We thank the patients, their families, and the physicians involved in the CheckMate-331 study.”

FDA Extends Review of Atezolizumab by 3 Months

The FDA has extended by 3 months the review period for atezolizumab in combination therapy as first-line treatment for a form of lung cancer.

Atezolizumab in combination with bevacizumab, carboplatin, and paclitaxel was granted priority review from the FDA in May for the initial treatment of people with metastatic nonsquamous non–small cell lung cancer (NSCLC).

It is already approved in the European Union, United States, and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma.

“The extension allows the FDA time to review additional information requested in support of the supplemental Biologics License Application,” Roche said in a statement. The FDA is expected to make a decision on approval by December 5, 2019.

Last modified: August 10, 2023

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