Merck's PD-1 monoanti-Keytruda combined chemotherapy for advanced urinary skin cancer, Phase III clinical failure

Merck announced that its PD-1 monoanti-Keytruda (pembrolizumab) combination of first-line chemotherapy treatment for patients with advanced or metastatic urethra skin cancer in Phase III clinical lysis did not meet the end point of its total survival (OS) or progression-free survival (PFS) significantly improvedRoy Baynes, chief medical officer at Merck Research, said that while the company is "disappointed" by the results of KEYNOTE-361, "Keytruda has been identified as an important option for the treatment of metastatic bladder cancer and we are committed to continuing to help more patients." The trial recruited 1,010 patients with previously untreated advanced or metastatic urethra skin cancer who were randomly assigned to receive Keytruda monodrug or combined chemotherapy, or chemotherapy aloneIn addition to the main OS and PFS endpoints, secondary targets include mitigation time, disease control rates, and overall mitigation ratesOS and PFS indicators improved in patients receiving Keytruda combined chemotherapy compared to individual chemotherapy, but were not statistically significantKeytruda's first-quarter sales rose 45 percent to $3.3 billion, and it has three FDA-approved bladder cancer indications, including first- and second-line treatments for specific types of localized advanced or metastatic urethra skin cancer patients in 2017Keytruda's indications were also expanded earlier this year to treat patients with non-responsive, high-risk, muscle-free bladder cancerLast month, results from the Phase III JAVELIN Bladder 100 trial of Merck and Pfizer's PD-L1 monoanti-Bavencio (avelumab) for patients with advanced urinary skin cancer showed that Bavencio could extend OS by 7.1 months compared to standard treatment