Drug major Merck & Co. Inc. (MRK) announced Friday that the U.S. Food and Drug Administration has approved its anti-PD-1 therapy KEYTRUDA as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a 4 centimeters), II, or IIIA non-small cell lung cancer or NSCLC.
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, the company noted.
The FDA 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 or DFS.
The company noted that KEYTRUDA reduced the risk of disease recurrence or death by 27% in patients who received adjuvant platinum-based chemotherapy following surgical resection, compared to placebo regardless of PD-L1 expression.
The median DFS in patients regardless of PD-L1 expression who received adjuvant platinum-based chemotherapy following surgical resection was nearly five years or 58.7 months for the KEYTRUDA arm versus nearly three years or 34.9 months for the placebo arm, translating to a nearly two-year DFS improvement versus placebo.
Gregory Lubiniecki, vice president, oncology global clinical development, Merck Research Laboratories, said, "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."
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