MSD’s Keytruda snatches up first approval in small cell lung cancer

pharmafile | June 19, 2019 | News story | Research and Development, Sales and Marketing Cancer, FDA, MSD, US, keytruda, lung cancer, pharma 

MSD has revealed that its anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been awarded marketing authorisation from the FDA as a monotherapy in the treatment of metastatic small cell lung cancer (SCLC) in adults whose disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.

The approval was given under the FDA’s accelerated review pathway, and was based on data from 83 participants across two trials, 64% had received two prior lines of therapy and 36% had received three or more; 60% had received prior thoracic radiation therapy and 51% had received previous radiation therapy to the brain.

The findings showed that 16 patients responded in total: the drug demonstrated an objective response rate of 19%, a complete response rate of 2% and a partial response rate of 17%. Response durations ranged between 4.1 months and 35.8+ months; of these 16 responders, 94% achieved a response lasting more than six months, 63% saw a response of 12 months or longer, and 56% saw responses of 12 months or longer.

“Small cell lung cancer, which accounts for 10% to 15% of all lung cancers, is often diagnosed at an advanced stage where the prognosis is very poor and there have historically been limited treatment options,” remarked Dr Patrick Ott, Clinical Director at the Center for Immuno-Oncology, Dana-Farber Cancer Institute. “The approval of Keytruda in small cell lung cancer provides an additional treatment option for patients based on the clinical response rates from KEYNOTE-158 and KEYNOTE-028.”

Dr Jonathan Cheng, Vice President, Oncology Clinical Research at MSD, also commented on the new approval: “Keytruda is already an established treatment option for non-small cell lung cancer, and today’s approval in small cell lung cancer demonstrates our commitment to bringing forward new treatment options for patients with advanced, difficult-to-treat cancers. We look forward to continuing to advance important clinical research in small cell lung cancer.”

Matt Fellows

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