Merck's Keytruda takes home adjuvant win in melanoma, escalating early-line fight with Bristol Myers
With immune checkpoint inhibitors quickly emerging as standard of care across a broad range of advanced cancers, the biggest drugmakers in the race are making a hard push into earlier lines of therapy to gain an edge. The biggest dog in the fight, Merck, now has data that could spell a quick approval and sales bump.
Keytruda beat out placebo in staving off the recurrence of cancer as an adjuvant therapy in patients with high-risk stage II melanoma after surgery to remove their tumors, according to topline data from the KEYNOTE-716 study released Thursday.
Although full data weren’t available, the early look paints the picture of a big win for Merck, which is battling for earlier lines of therapy for Keytruda in a heated fight among the PD-(L)1 players, most notably Bristol Myers Squibb’s Opdivo.
With data in hand, Merck snared a snap priority review from the FDA with an action date set for Dec. 4. The drugmaker expects to present full data at an upcoming medical meeting.
The two-part KEYNOTE-716 study first randomized patients on Keytruda or placebo for up to a year of dosing after surgery. That was followed by a two-year open-label period for patients who either did not see their disease recur after one year of Keytruda or did see it recur on placebo.
The data add another jewel to Merck’s crown in adjuvant/neoadjuvant immunotherapy with other wins in breast, bladder and kidney cancer already on the mantlepiece.
Just days ago, the FDA approved a regimen of Keytruda plus chemo as a neoadjuvant combo followed by adjuvant Keytruda monotherapy in patients with high-risk triple-negative breast cancer, which officially became the drug’s first win in that early-line setting.
The data underscoring that approval were particularly contentious: FDA handed Merck a complete response letter on the results, citing a lack of mature safety data and questions over the pivotal study’s pathologic complete response endpoint. But Merck within weeks rolled out that OS data showing a win on more mature survival data, and causing the FDA to reverse its earlier decision.
In early June, Merck rolled out data for Keytruda in adjuvant kidney cancer, with the drug cutting the risk of cancer relapse or death by 32% after a little more than two years compared with placebo in renal cell carcinoma patients with a mid-to-high risk of recurrence after a kidney removal, or after removal of a kidney and metastatic lesions.