Merck Presents Early-Stage Interim Data for MK-3475, an Investigational Therapy for the Treatment of Advanced Melanoma


November 11, 2012 2:00 pm ET

Phase II Study Being Initiated

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

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

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
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Ronald Rogers, 908-423-6449
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088

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