Merck has reported positive five-year data from the Phase Ib KEYNOTE-001 study of Keytruda as a single agent in advanced non-small cell lung cancer (NSCLC).

According to the results, the anti-programmed cell death protein 1 (PD-1) drug led to 23.2% overall survival (OS) rate in treatment-naïve patients and 15.5% in previously treated subjects over five years.

The study involved one of the longest follow-ups for the drug in lung cancer, which showed a five-year OS rate of 29.6% in treatment-naïve patients with PD-L1 expressing tumours. In previously treated patients, the rate was observed to be 25%.

Median follow-up of 60.6 months showed an objective response rate (ORR) of 41.6% in treatment-naïve patients and 22.9% in participants who had prior treatment.

Of the 60 subjects who were on Keytruda for two or more years, treatment-naïve patients showed a 78.6% OS rate, while previously treated patients had 75.8%. In these subjects, the ORR was 86% and 91%, respectively.

Meanwhile, the median duration of response (DOR) was found to be 52 months in treatment-naïve subjects, while previously treated patients did not reach the range.

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By GlobalData

During the trial, the safety profile of the drug was consistent with that of previously reported studies in advanced NSCLC patients.

Treatment-related adverse events (TRAE) of any grade were found in 71% of patients receiving Keytruda. The most commonly reported immune-mediated adverse event was hypothyroidism, followed by pneumonitis, hyperthyroidism and skin toxicities.

Merck Research Laboratories senior vice-president and chief medical officer Dr Roy Baynes said: “Five-year survival is a significant milestone for patients with advanced non-small cell lung cancer, and it is encouraging to see the long-term overall survival rates from our first KEYNOTE study.

“These five-year data provide important insights into the long-term safety and efficacy of Keytruda in patients with advanced non-small cell lung cancer.”

The company reported positive outcomes from other trials assessing the drug in NSCLC, including KEYNOTE-189.