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Merck reports early data on investigational use of KEYTRUDA in patients with advanced bladder cancer

Merck, known as MSD outside the United States and Canada, has announced the first presentation of data on the investigational use of KEYTRUDA (pembrolizumab) – the company’s anti-PD-1 therapy – in PD-L1 positive, advanced urothelial cancer (also known as bladder cancer).

The early findings presented showed a confirmed overall response rate of 24 percent with KEYTRUDA as monotherapy, as measured by RECIST v1.1, central review (n= 7/29: 95% CI, 10.3-43.5) including a complete response rate of 10 percent (3/29).

At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64 percent (61/95) of patients screened had tumors that were determined to be positive for PD-L1 expression.

These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented today, as part of a late-breaking oral session, by Dr. Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain (ABSTRACT #LBA23).

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

"Although at this stage the dataset is small, we are encouraged by the response rate, complete response rate, and the durability of the response in patients suffering from advanced bladder cancer," said Dr. Alise Reicin, vice president, oncology, Merck Research Laboratories.

"As communicated previously, based on these data Merck will initiate a Phase 3 study this year to better understand the potential of KEYTRUDA in advanced bladder cancer."

Early findings for investigational use of KEYTRUDA in advanced bladder cancer

Data from a cohort of the ongoing Phase 1b KEYNOTE-012 study evaluated KEYTRUDA monotherapy at 10 mg/kg every two weeks in patients with advanced bladder cancer whose tumors were determined to be positive for PD-L1 expression (n=29). As measured by Merck’s proprietary immunohistochemistry (IHC) clinical trial assay, tumors were classified as PD-L1 positive based on greater than or equal to one percent of tumor cells demonstrating expression of the PD-L1 marker, or any positive staining with the same reagent in tumor stroma. The majority of patients had received one or more prior lines of therapy.