The FDA approved Merck’s Keytruda for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy.
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The FDA approved Merck’s Keytruda (pembrolizumab) for the treatment of stage IB, II or IIIA non-small cell lung cancer after resection or platinum-based chemotherapy, the company announced Friday.
With the regulatory nod, Keytruda becomes the only immunotherapy approved for both metastatic and adjuvant NSCLC regardless of PD-L1 expression status, the company stated in a press release.
This is the blockbuster drug’s fifth approval in NSCLC. Its first approval in this space came in October 2015 for advanced NSCLC, followed by a series of other approvals in different disease stages and in combination with various drugs.
Data from the randomized, triple-blinded and placebo-controlled Phase III KEYNOTE-091 trial formed the basis for Thursday’s approval. The study met its primary endpoint, posting a significant improvement in investigator-assessed disease-free survival (DFS), its major efficacy metric.
In patients treated with adjuvant platinum-based chemotherapy, the median DFS was 58.7 months in the Keytruda arm, as opposed to only 34.9 months in the placebo arm. The effect, deemed statistically significant, corresponded to a 27% reduction in risk of death or disease recurrence.
In a statement, Roy S. Herbst, M.D., Ph.D., deputy director and chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital, said surgery remains the primary treatment for stage IB, II and IIIA NSCLC.
However, these patients still often see cancer recurrence, for which this latest Keytruda approval could prove valuable.
Adverse events in KEYNOTE-091 were generally consistent with what had been recorded in previous trials. Hypothyroidism, hyperthyroidism and pneumonitis were common side effects in this study. Two patients died of myocarditis.
A PD-1 checkpoint inhibitor, Keytruda is Merck’s top-performing asset, earning more than $15 billion in year-to-date revenue by the end of Q3, 2022. Aside from NSCLC, the drug is also approved for Hodgkin lymphoma, melanoma, colorectal cancer, cervical cancer, breast cancer and hepatocellular carcinoma, among several other indications.
At the 41st J.P. Morgan Healthcare Conference, Merck named Keytruda as the cornerstone of its growth strategy for the coming year. The company plans to further establish the drug as a foundational anti-PD-1 therapeutic in cancer, both alone and in combination with other treatments.
Two Hits and a Miss
Thursday’s approval caps a busy week for Keytruda. On Wednesday, the company posted back-to-back data drops for the drug.
Keytruda met its primary efficacy endpoint in the Phase III KEYNOTE-966 trial, investigating its potential as a first-line therapy for advanced or unresectable biliary tract cancer, in combination with gemcitabine and cisplatin. Merck plans to engage regulatory authorities with these data.
Meanwhile, Keytruda suffered a rare defeat in the Phase III KEYNOTE-991 study, failing to significantly boost overall survival and radiographic progression-free survival in patients with metastatic hormone-sensitive prostate cancer. Keytruda also triggered more grade 3-5 adverse and serious adverse events than placebo.
Merck is discontinuing the trial for futility, in line with recommendations from an independent Data Monitoring Committee.
