Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced additional data for MK-3475, an investigational anti-PD-1 immunotherapy, in patients with advanced melanoma that showed an estimated overall survival rate of 81 percent at one year across all MK-3475 monotherapy doses evaluated. This is the first time overall survival data have been presented from the cohort of 135 patients with advanced melanoma enrolled in Merck’s ongoing Phase IB clinical trial (PN 001) for MK-3475. Researchers presented the findings today in an oral plenary session at the 10th International Congress of the Society for Melanoma Research in Philadelphia.
“New agents are needed for patients with advanced melanoma,” said Dr. Caroline Robert, head of Dermatology at Gustave Roussy, Cancer Campus, Grand Paris. “I am excited by the results seen for MK-3475 to date as a single agent and believe these findings support further study both as a monotherapy and in combination in various solid tumors.”
The objective response rate (patients who had either a complete or partial response) across all doses improved with longer duration of follow-up; at the time of this analysis, the objective response rate was 41 percent (9 percent complete response rate), as evaluated by a blinded central review committee using RECIST 1.1 (Response Evaluation Criteria in Solid Tumors). While the majority of responses to MK-3475 treatment occurred early (within the first 12 weeks), responses and changes from partial to complete response continued to occur after six months of treatment. Partial and complete responses occurred as late as 48 and 70 weeks. Median duration of response and median overall survival have yet to be reached for any dose evaluated.
“These results provide further insight into the therapeutic properties of MK-3475 in patients with advanced melanoma,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Simply put, our data make us hopeful that this novel investigational therapy could potentially provide meaningful benefits to patients suffering from this malignant disease.”