Merck’s KEYTRUDA® Demonstrated Long-Term Survival Benefit Based on Four and Five Years of Follow-Up from Two Pivotal Studies in Advanced Melanoma

Merck announced long-term efficacy data from the Phase 3 KEYNOTE-006 study and the
melanoma cohort of the Phase 1b KEYNOTE-001 study investigating KEYTRUDA, Merck’s
anti-PD-1 therapy, in patients with advanced melanoma. A new analysis from KEYNOTE-006
demonstrated durable efficacy benefits among patients who completed two years of
KEYTRUDA treatment, combined with updated overall survival (OS) results across both
studies, confirming anti-tumor activity in advanced melanoma patients.
At a median follow-up of 20.3 months after completion of KEYTRUDA in KEYNOTE-006, 86
percent of patients remained progression-free, the co-primary endpoint for the study. For the
primary endpoint of OS in KEYNOTE-006, the four-year OS rate was 41.7 percent in the pooled
KEYTRUDA arms vs. 34.1 percent in the ipilimumab arm; in treatment-naïve patients, OS rates
were 44.3 percent in the pooled KEYTRUDA arms and 36.4 percent in the ipilimumab arm. In
KEYNOTE-001, the five-year OS rate, a secondary endpoint for the study, was 34 percent in all
patients and 41 percent in treatment-naïve patients. The safety profile of KEYTRUDA in both
studies was consistent with what has been seen in previous trials among patients with advanced
melanoma. Results for KEYNOTE-006 (Abstract #9503) and KEYNOTE-001 (Abstract #9516)
are being presented today at the 2018 American Society of Clinical Oncology (ASCO) Annual
“Looking across the findings for both KEYNOTE-006 and KEYNOTE-001 we are seeing further
validation that KEYTRUDA is significantly extending the survival of first-line metastatic
melanoma patients, regardless of tumor BRAF-mutation status,” said Scot Ebbinghaus, M.D.,
vice president, clinical research, Merck Research Laboratories. “In KEYNOTE-006, we are also
seeing durable efficacy benefits for patients who complete two years of KEYTRUDA treatment.
We are pleased to share data that further reinforce KEYTRUDA monotherapy as a standard of
care in advanced melanoma patients and deliver on our goal of improving and extending the
lives of melanoma patients.”
“Pembrolizumab had already established superior survival outcomes versus ipilimumab in
advanced melanoma patients, and this is further reinforced with four years of data in
KEYNOTE-006,” said Professor Georgina V. Long, conjoint medical director of Melanoma
Institute Australia (MIA), and chair of Melanoma Medical Oncology and Translational Research
at MIA and Royal North Shore Hospital, The University of Sydney. “Importantly, we’re now
seeing ongoing efficacy for patients who complete the protocol-specified two years of
pembrolizumab treatment, as well as additional anti-tumor activity for the patients who progress
after a first course of treatment and complete a second course of treatment.”
“Updated data for KEYNOTE-001 demonstrate significant survival benefits in advanced
melanoma patients,” said Omid Hamid, M.D., chief of Translational Research and Immuno-
Oncology and director of Melanoma Therapeutics, The Angeles Clinic and Research Institute,
Los Angeles, California. “Five-year survival is a true milestone for oncology patients,

particularly among those living with metastatic melanoma, so it is incredibly exciting to share
these updated data.”
Merck’s long-term commitment to melanoma includes a broad clinical development program
studying KEYTRUDA as monotherapy and in combination with other novel mechanisms. The
program, which is comprised of more than 4,500 patients across 10 Merck-sponsored clinical
studies, is evaluating KEYTRUDA across all settings and stages of the disease.

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