Bristol-Myers Squibb’s Opdivo is currently the only immuno-oncology treatment approved to treat kidney cancer—but yet another pair of rivals is now moving in to threaten that status.
Merck’s Keytruda, in tandem with Eisai’s Lenvima, has nabbed the FDA’s breakthrough therapy designation as a potential treatment for patients with advanced and/or metastatic renal cell carcinoma, setting the partners up for a sped-up trip down the regulatory pathway.
The designation follows “impressive” data from the duo, which, in a phase 1b/2 study last year, posted overall response rates of 83% in the first-line setting and 50% in second-line or greater, Leerink Partners analyst Seamus Fernandez wrote in a note to clients.
“Although based on small numbers, these ORRs compare favorably to those seen with other PD-1/L1 combos,” he pointed out.
Bristol-Myers, whose PD-1 drug currently bears an indication only for previously treated patients, is working to snap up as much market share as possible before competition descends. In October, commercial chief Murdo Gordon said the treatment had already grabbed more than 50% of the pie, and the company is working to snag a front-line approval that would roughly double Opdivo’s patient pool in kidney cancer.
The FDA is due to make a decision by mid-April on whether to bless Opdivo and fellow BMS drug Yervoy in the first-line setting, and Roche’s Tecentriq-plus-Avastin one-two punch will be “following on its heels,” Fernandez wrote. Then, there’s the combination of Pfizer and Merck KGaA’s Bavencio and Pfizer’s Inlyta, which picked up its own breakthrough designation earlier this month. And a Keytruda-Inlyta phase 3 trial is currently ongoing, too.
All of that means time is of the essence for Merck and Eisai, whose first-line phase 3 trial is expected to read out in 2019 or early 2020. “Competition in this space is heating up and it is unclear how quickly this BTD could accelerate a filing,” Fernandez wrote.