September 29, 2014
By Riley McDermid, BioSpace.com Breaking News Staff
Biopharma behemoth Merck & Co., Inc. said Monday that its newly approved melanoma cancer drug Keytruda has shown positive results in extending its immune system benefits to treat patients with bladder cancer as well.Keytruda (pembrolizumab), is the company’s anti-PD-1 therapy in PD-L1 positive subjects, and was tested on patients with advanced urothelial cancer (bladder cancer).
The new data was presented today Kei Muro, of Aichi Cancer Center Hospital, Nagoya, Japan, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain.
Merck said early findings showed a confirmed overall response rate of 24 percent with Keytruda as monotherapy, as measured by RECIST v1.1, central review including a complete response rate of 10 percent.
“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 Alise Reicin, vice president, oncology, Merck Research Laboratories, in a statement. “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.” Adverse events were consistent with previously reported safety data for Keytruda, the company said.
Keytruda was approved in early September by the U.S. Food and Drug Administration a mere three-and-a-half years after the first doses of the medicine were given to patients in clinical trials.
The drug’s super-fast approval quickly caught the eye of analysts because it allowed it to leapfrog a similar drug from Bristol-Myers Squibb (BMY).
Keytruda was lauded as a triumph for Merck’s research head Roger Perlmutter, who only arrived at Merck 18 months ago and quickly expanded the drug’s existing phase I trial , which lacked a control group of patients getting other treatments, to 3,500 patients with a variety of different cancers.
The approval was based on 173 patients with advanced melanoma, and 41 saw tumor shrinkage for between 1.4 months to 8.5 months. For most of the patients who responded, the tumor shrinkage has persisted.
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.
