FDA Approval Insights: Adjuvant Pembrolizumab in Stage IB, II, or IIIA NSCLC


Dr Herbst discusses the FDA approval of adjuvant pembrolizumab in non–small cell lung cancer, key efficacy and safety data from the KEYNOTE-091 trial, and future research efforts that may further improve outcomes in this population.

Welcome to OncLive On Air®! I’m your host today, Ashling Wahner.

OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, we had the pleasure of speaking with Roy S. Herbst, MD, PhD, about the FDA approval of adjuvant pembrolizumab (Keytruda) in patients with non–small cell lung cancer (NSCLC). Dr Herbst is the Ensign Professor of Medicine (Medical Oncology), professor of pharmacology, director of the center for thoracic cancers, and assistant dean for translational research in the Office of the Dean at the Yale School of Medicine, as well as the chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital and the deputy director of Yale Cancer Center in New Haven, Connecticut.

On January 26, 2023, the FDA approved pembrolizumab as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage IB, II, or IIIA NSCLC. The approval was backed by the results of the phase 3 PEARLS/KEYNOTE-091 trial (NCT02504372), in which patients who received adjuvant chemotherapy achieved a median disease-free survival of 58.7 months with pembrolizumab vs 34.9 months with placebo.

In our exclusive interview, Dr Herbst discussed the significance of this approval, key efficacy and safety data from KEYNOTE-091, and future research efforts that may further improve outcomes in this population.


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