First-line Keytruda meets co-primary endpoints in advanced melanoma

First-line pembrolizumab conferred significant and clinically meaningful improvements in its co-primary endpoints of PFS and OS compared with ipilimumab in a randomized phase 3 study of patients with advanced melanoma, according to a press release from the drug’s manufacturer.

Based on these findings, the Independent Data Monitoring Committee recommended the KEYNOTE-006 trial be stopped early.

Roger Perlmutter

Pembrolizumab is currently approved in the U.S. for patients with unresectable or metastatic melanoma who progressed on treatment with ipilimumab (Yervoy, Bristol-Myers Squibb) or a BRAF inhibitor if the patient harbors a BRAF V600 mutation.

Researchers of the KEYNOTE-006 trial sought to compare 10 mg/kg pembrolizumab (Keytruda, Merck) vs. 3 mg/kg ipilimumab as first-line therapy in 834 patients with advanced melanoma.

Pembrolizumab demonstrated a similar safety profile in this trial to its safety profile previously observed in advanced melanoma. The most common adverse reactions included fatigue (47%), cough (30%), nausea (30%), pruritus (30%), rash (29%), decreased appetite (26%), constipation (21%), arthralgia (20%) and diarrhea (20%). Thirty-six percent of patients who received pembrolizumab experienced serious adverse events, the most common of which were renal failure, dyspnea, pneumonia and cellulitis.

Survival data from the KEYNOTE-006 trial will be presented in April at the American Association of Cancer Research (AACR) Annual Meeting.

"Evidence from our clinical program for Keytruda will help to define the appropriate treatment of advanced melanoma," Roger Perlmutter, MD, PhD, president of Merck Research Laboratories, said in a press release. "We greatly appreciate the efforts of our investigators and their patients in this important study, and we look forward to the presentation of OS data from Keynote-006 at the AACR annual meeting."