Merck's Keytruda builds its melanoma case against Opdivo with postsurgery trial win

Merck
In a trial in postsurgery melanoma patients, Merck's Keytruda cut the risk of disease recurrence or death by 43% compared with placebo. (Merck)

Merck needed a big win in melanoma to help it try to catch up to archrival Bristol-Myers Squibb. And over the weekend, it got one.

At the American Association for Cancer Research annual meeting Sunday, the New Jersey drugmaker rolled out results showing that in postsurgery patients, Keytruda cut the risk of disease recurrence or death—leading to progression-free survival in those patients—by 43% compared with placebo.

At the one-year mark, 75.4% of Keytruda patients hadn’t seen their disease return, while just 61% of patients on placebo could say the same. And in those with PD-L1-positive tumors, Keytruda’s benefit was even more pronounced, paring down the recurrence risk by 46%.

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Roy Baynes, Merck’s head of global clinical development, in a statement called the data “compelling” and added that they “mark an important advancement for the treatment of resected stage 3 melanoma.”

Now, Merck will wait for word from regulators around the world—and if it gets its green lights, it’ll head into battle with Bristol and its own immuno-oncology contender Opdivo. That drug snagged its adjuvant go-ahead in late December after a speedy review at the FDA.

RELATED: Bristol-Myers' Opdivo gets into high gear for new melanoma approval

While the two nemeses have racked up competing indications across various cancer types, the rivalry started in melanoma, the disease area in which each drug won its first-ever approval. Merck got the party started back in September of 2014, with BMS following up with its own OK that December.

These days, though, investors are focused squarely on first-line lung cancer, the immuno-oncology market’s most lucrative setting. Also at AACR, both companies rolled out positive results for their combo regimens, with Merck’s Keytruda-chemo combo posting big overall survival data across the PD-L1 spectrum and Bristol’s Opdivo-Yervoy pairing successfully staving off disease progression in patients with high tumor mutation burden.