Merck & Co. said Monday that a Phase III study investigating Keytruda (pembrolizumab) as monotherapy for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) met its primary endpoint of overall survival (OS). The company noted that the KEYNOTE-042 trial will continue to evaluate progression-free survival, which is a secondary goal.
The study randomised 1274 patients with locally advanced or metastatic PD-L1-positive NSCLC to receive either Keytruda as monotherapy or investigator's choice of platinum-based chemotherapy. According to Merck, an interim analysis conducted by the independent Data Monitoring Committee demonstrated that treatment with Keytruda resulted in significantly longer OS than platinum-based chemotherapy in patients with a PD-L1 tumour proportion score (TPS) of at least 1 percent. The drugmaker noted that as part of a pre-specified analysis plan, OS was sequentially tested and was significantly improved in patients with a TPS of at least 50 percent, with a TPS of at least 20 percent and then in the entire study population with a TPS of at least 1 percent.
Roger Perlmutter, president of Merck Research Laboratories, said "with KEYNOTE-042, Keytruda has now shown a significant survival benefit compared with chemotherapy for patients with locally advanced or metastatic non-squamous or squamous NSCLC expressing PD-L1 at 1 percent or higher by tumour proportion score." The drugmaker indicated that results from the study will be presented at an upcoming medical meeting and submitted to global regulatory authorities.
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Keytruda, which generated sales of $3.8 billion last year, is currently approved for a number of different tumour types, including as a single agent for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations. The anti-PD-1 therapy is also authorised to treat patients with metastatic NSCLC whose tumours express PD-L1, with disease progression on or after platinum-containing chemotherapy, as well as in combination with pemetrexed and carboplatin, for the first-line treatment of patients with metastatic nonsquamous NSCLC.
In January, Merck announced that the late-stage KEYNOTE-189 study investigating Keytruda in combination with chemotherapy for the first-line treatment of patients with metastatic non-squamous NSCLC met its dual primary endpoints of OS and progression-free survival. For related analysis, see ViewPoints: Merck & Co.'s winning streak could prove decisive in front-line NSCLC chase, and Physician Views Poll Results: Multiple barriers to 'chemo combo' use in first-line NSCLC patients exist - will Keynote-189 data unlock this market?
For related analysis, read also ViewPoints: Keytruda raises bar again for anti-PD-(L)1 drugs in 1L lung cancer.
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