Merck, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters [cm]), II, or IIIA non-small cell lung cancer (NSCLC).

The approval is based on data from the pivotal Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS. The major efficacy outcome measure was investigator-assessed disease-free survival (DFS). In patients who received adjuvant platinum-based chemotherapy following surgical resection, KEYTRUDA reduced the risk of disease recurrence or death by 27% versus placebo regardless of PD-L1 expression.

“While there have been many advances for patients with metastatic disease, surgery remains the typical treatment for people with stage IB, II and IIIA non-small cell lung cancer. Unfortunately, many of these patients who undergo surgery still see their disease return,” said Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital and ensign professor of medicine (medical oncology) and professor of pharmacology, Yale School of Medicine.

“Today’s approval for KEYTRUDA offers a new, important immunotherapy treatment option for stage IB (T2a ≥4 cm), II, or IIIA patients with non-small cell lung cancer following surgery and adjuvant chemotherapy. This provides, for the first time, an adjuvant immunotherapy treatment option for non-small cell lung cancer patients with stage IB disease and regardless of PD-L1 expression.”

The adverse reactions observed in KEYNOTE-091 were generally similar to those occurring in other patients with NSCLC receiving KEYTRUDA as a single agent, with the exception of hypothyroidism (22%), hyperthyroidism (11%), and pneumonitis (7%). Two fatal adverse reactions of myocarditis occurred.

“Six years ago, KEYTRUDA was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. Today’s approval marks the fifth indication for KEYTRUDA in non-small cell lung cancer and the first indication for KEYTRUDA in patients with resected stage IB (T2a ≥4 cm), II, or IIIA disease following adjuvant chemotherapy,” said Dr. Gregory Lubiniecki, vice president, oncology global clinical development, Merck Research Laboratories. “This is an important milestone as we continue our efforts to pursue meaningful advances for patients with non-small cell lung cancer.”

With this approval, KEYTRUDA is the only immunotherapy with an approved option for NSCLC regardless of PD-L1 expression in both the adjuvant and metastatic settings.