Merck & Co. announced Sunday at the American Society of Clinical Oncology (ASCO) annual meeting that in the KEYNOTE-042 trial, the use of Keytruda (pembrolizumab) as monotherapy for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer (NSCLC) in patients with a PD-L1 tumour proportion score (TPS) of at least 1 percent resulted in median overall survival (OS) of 16.7 months versus 12.1 months for chemotherapy. Roy Baynes, head of clinical development at Merck, said the data "set the floor against which other therapies will need to be compared."
In April, Merck reported that the study met its primary endpoint of OS, noting at the time that the trial will continue to evaluate progression-free survival (PFS), 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.
Results detailed at the ASCO conference showed that median OS in patients with a TPS of at least 50 percent was 20.0 months in the Keytruda arm versus 12.2 months for chemotherapy. In addition, in patients with a TPS of at least 20 percent, median OS was 17.7 months and 13 months in the two groups, respectively. Merck also noted that an exploratory subgroup analysis in patients with a TPS of 1 percent to 49 percent showed an OS HR of 0.92
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Further data showed that at interim analysis, Keytruda reduced disease progression or death by 19 percent in patients with PD-L1 TPS of at least 50 percent, which Merck noted was not significant versus chemotherapy. The drugmaker added that based on the recommendation of the external Data Monitoring Committee, PFS will continue to be evaluated at the final analysis.
Results also showed that Grade 3-5 treatment-related adverse events occurred in 17.8 percent of patients in the Keytruda group, compared to 41 percent in the chemotherapy group. Lead author Gilberto Lopes commented "a large number of patients with lung cancer now have a new treatment option with better efficacy and fewer side effects than standard chemotherapy."
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. Roger Perlmutter, president of Merck Research Laboratories, said the company will submit the data from the KEYNOTE-042 trial to global regulatory authorities.
Separately on Sunday, Merck announced that Keytruda plus chemotherapy reduced the risk of death by 36 percent compared to chemotherapy alone as a first-line treatment for patients with metastatic squamous NSCLC. "We have the data; we have demonstrated the efficacy of Keytruda broadly across five randomised trials, all positive," commented Baynes, adding "oncology is a data-driven specialty and I think the data speak for themselves right now."
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