Phase II Study Being Initiated
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of early interim results from a single-arm, open-label Phase IB study that has so far enrolled 132 patients with advanced (inoperable and metastatic) melanoma who have received MK-3475, Merck’s investigational immune-modulating therapy. Omid Hamid, M.D., Director of the Melanoma Center at the Angeles Clinic and Research Institute, Los Angeles, presented the data during a late-breaking clinical trials session at the Society for Melanoma Research of the 9th International Congress of the Society for Melanoma Research (SMR) in Hollywood, Calif.
"A key element of Merck’s oncology strategy is to identify therapeutic candidates with the potential to make a meaningful difference for patients with difficult-to-treat cancers," said Gary Gilliland M.D., Ph.D., senior vice president and oncology franchise head, Merck Research Laboratories. "Based upon the severe unmet medical need in advanced melanoma and the early interim results from this clinical trial, Merck is moving ahead with a clinical development program designed to analyze MK-3475 in a larger advanced melanoma population."
Patients were administered MK-3475 in one of three regimens: low dose every 3 weeks, high dose every 3 weeks and high dose every 2 weeks. Following an initial disease evaluation, patients received one of the three regimens of MK-3475. After 12 weeks, disease status was evaluated by the investigator and compared to baseline using immune-related response criteria (irRC). Those patients demonstrating stable disease or response at the 12-week evaluation time point continued to receive MK-3475 and follow-up monitoring.
Data has so far been obtained for 85 of the 132 patients enrolled in the study. Of those patients, a total of 43 patients (51 percent) showed an objective anti-tumor response, and of those, 8 patients (9 percent) showed a complete response at or after the 12-week assessment. Notably, of the 27 patients who had previously been treated with ipilimumab monotherapy, the current standard of care for late-stage melanoma, 11 patients (41 percent) showed an objective anti-tumor response to MK-3475 monotherapy; none of those patients showed a complete response.
The most common adverse events experienced by patients who received MK-3475 included fatigue, rash, diarrhea, nausea, cough, joint pain, fever and itching. Seven MK-3475 related Grade 3/4 adverse events were reported as potentially “immune related.”
Merck recently initiated a global, randomized, Phase II clinical trial to evaluate MK-3475 versus standard chemotherapy for participants with advanced melanoma whose disease has progressed after prior therapy (reference: NCT01704287). Participants will be randomized to receive one of two doses of MK-3475 or investigator-choice chemotherapy. For further information, please visit http://www.clinicaltrials.gov.
About PD-1 and MK-3475
Research has shown that PD-1, an immune checkpoint receptor, helps to confer immune resistance for some cancers allowing tumor cells to grow and proliferate unchecked. MK-3475 is a monoclonal antibody designed to target PD-1 to disrupt the role PD-1 plays in resisting the immune system.
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