FDA OKs Merck’s heavyweight Keytruda for cancer niche — triggering title fight with the street brawlers at Regeneron
When Regeneron won its first OK for their PD-1 Libtayo as a treatment for recurrent or metastatic cutaneous squamous cell carcinoma, the second most common form of skin cancer, company president George Yancopoulos crowed about their ability to grab a major niche market left wide open by the 2 big powerhouses in the field, Merck and Bristol Myers.
Today, though, Regeneron and their partners at Sanofi no longer enjoy a monopoly in that particular field. Merck grabbed an OK for their top-selling PD-1 Keytruda in the same group of patients. But don’t expect Regeneron — still struggling to boost sales — to let go of their best-in-class claims.
Keytruda garnered the FDA approval based on an “objective response rate (ORR) of 34% (95% CI, 25-44), including a complete response rate of 4% and a partial response rate of 31%. Among responding patients, 69% had ongoing responses of six months or longer. After a median follow-up time of 9.5 months, the median duration of response (DOR) had not been reached (range, 2.7 to 13.1+ months).”
When Regeneron scored their way into the market, they counted an ORR of “47% (95% CI: 38, 57), with 4% complete and 44% partial response rates … The median response duration was not reached (range: 1.0 to 15.2+ months), and 61% of responses were durable for 6 months or longer.”
Cross-trial comparisons are always dicey, but Regeneron is a pugnacious player, likely to spotlight any advantage. When I talked to Yancopoulos about it at JPMorgan in early 2019, he asked why Merck and others were running “thousands” of checkpoint trials, but no one went after CSCC ahead of Regeneron.
His answer: Because they aren’t nearly as smart.
“It’s so mindless they missed this huge opportunity,” he added emphatically, without trying to hide his contempt.
He also described prescribing a rival PD-L1 for anything as “medical malpractice” as he went on to trash Bavencio from Pfizer and Merck KGaA.
The opportunity Yancopoulos referred to is still fairly small potatoes compared to Keytruda’s $12 billion reign as the world’s leading PD-1 checkpoint. Libtayo earned only $193 million last year, underscoring just how hard it is for the world’s 6th PD-(L)1 to carve out a franchise.
Regeneron, though, isn’t afraid to go toe-to-toe with Merck. They underscored that with positive data in April for first-line patients with non-small cell lung cancer that tested positive for PD-(L)1.
Regeneron — which has an outstanding rep in R&D — never backs down from a fight unless it’s been forced to, as with PCSK9. In the checkpoint drug community, no one expects them to waver now.