From Business Wire:
KEYTRUDA Data in Small Cell Lung Cancer and Mesothelioma
Merck, known as MSD outside the United States and Canada, today announced that updated findings from the phase 1b KEYNOTE-028 study investigating the use of KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, in previously treated patients with advanced small cell lung cancer (SCLC) and malignant pleural mesothelioma, showed clinical activity and durable responses in some patients. These data were featured in oral presentations at the 17th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer.
“As data from our initial trials exploring KEYTRUDA mature, we are encouraged to see durable clinical activity in difficult-to-treat cancers such as small cell lung cancer and malignant pleural mesothelioma, where new treatments are clearly needed,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “With our extensive immuno-oncology research program, we are developing KEYTRUDA across a range of thoracic malignancies, and we have additional studies underway in these two cancer types.”
KEYNOTE-028 is an ongoing multi-cohort, non-randomized Phase 1b basket trial evaluating the safety, tolerability, and anti-tumor activity of KEYTRUDA monotherapy (10 mg/kg dosed every two weeks) in more than 450 patients with PD-L1 positive tumors across 20 different types of cancer. PD-L1 positivity was defined as expression in one percent or more of tumor and associated inflammatory cells or positive staining in stroma. The primary outcome measure is overall response rate (ORR), with secondary outcome measures of progression-free survival (PFS), overall survival (OS), and duration of response.
The KEYTRUDA (pembrolizumab) clinical development program includes more than 30 tumor types in nearly 400 clinical trials, including more than 200 trials that combine KEYTRUDA with other cancer treatments. Merck has initiated a phase 2 trial, KEYNOTE-158, to further evaluate KEYTRUDA in advanced solid tumors including SCLC and malignant pleural mesothelioma.