Merck’s Keytruda reduces early-stage lung cancer recurrence by 24% post-surgery, with plans for FDA approval submission, and shows a favorable safety profile.

Merck’s Keytruda, a monoclonal antibody therapy, has shown promise in reducing the risk of early-stage lung cancer recurrence or death by 24% in patients post-surgery. The treatment consists of 200-milligram injections administered every three weeks for a year, with the aim of activating the immune system to combat non-small cell lung cancer. Following the promising clinical trial data, Merck plans to submit the findings to the FDA for approval.

In the clinical trial involving over 1,000 patients, those treated with Keytruda remained disease-free for a median of over four years, which is around a year longer than those who received a placebo. The trial included patients who had received chemotherapy and those who had not. While the data on overall survival rates is still maturing, Merck’s head of global clinical development, Dr. Roy Baynes, expects Keytruda to eventually show an improvement in overall survival rates.

Keytruda is generally well-tolerated, with thyroid toxicity being the most common side effect, and pneumonitis as a rare but serious complication. With $17.2 billion in sales in 2021, Keytruda represents a significant portion of Merck’s revenue, and its use to prevent lung cancer relapse post-surgery is seen as a major growth area. Currently, the FDA has approved only one other treatment, Tecentriq by Genentech, to prevent post-surgical lung cancer recurrence.