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. About Merck Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube. Merck Forward-Looking Statement This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov).