#ESMO20: 'As good as any PD-1 out there': Regeneron flashes PD-(L)1 lung cancer data to rival Merck
Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market.
They cleared a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma. And with the data they’re rolling out Monday, Regeneron cancer chief Israel Lowy is ready to declare success on the second.
“When we set out to develop a PD-1, we wanted to be sure no one had any doubt that cemiplimab was as good as any PD-1 out there,” Lowy told Endpoints News, using the chemical name for Libtayo. “I think that’s what we can say with confidence today.”
On Monday at ESMO, Regeneron rolled out the full Phase III data testing Libtayo as a monotherapy in non-small cell lung cancer. It’s the same setting where Merck’s Keytruda had one of its biggest successes, and where Bristol Myers Squibb’s Opdivo had one of its worst stumbles.
Across 710 patients, those who received Libtayo lived for a median of 22 months compared with 14 months on chemo. Notably, that translated to a 32% reduction in risk of death in all patients who expressed PD-L1. And for patients confirmed to express PD-L1 above 50%, there was a 43% reduction in risk of death.
Cross-trial comparisons are notoriously rough, but these numbers are in line or higher than what Merck reported for Keynote 042, its long-term study on Keytruda as a monotherapy in NSCLC. In that study, the reduction in risk of death was 32% for those who had more than 50% PD-L1 expression and 19% for those with PD-L1 expression above 1%. Lowy also argued the trial had a closer to real-world patient population, with looser enrollment criteria.
It’s not yet clear how much market share these numbers will net for Regeneron. Keytruda has a firm group on the market in NSCLC and many patients don’t receive a checkpoint inhibitor alone but rather a combination of checkpoint and chemotherapy. Lowy noted that some physicians will opt for monotherapy, particularly in patients with high expression who don’t want to undergo the rigors of chemo, but the company also has a trial testing chemo and Libtayo together vs. chemo alone that’s due to read out early next year.
More broadly, the new data establish Libtayo as a powerful PD-1 as Regeneron looks to make up for lost time. And they boost the big biotech’s broader strategy to break new efficacy ground with new combinations. Combos are the rage right now in checkpoint therapy, but Regeneron has outlined a relatively unique approach to the mix and match game.
For one, there’s the bispecifics the company has spent years developing and which they hope, in some cases, will work even better when mixed with Libtayo. They showed off one such combination in mice in a Science Translational Medicine cover story. Lowy also named combinations with oncolytic viruses and RNA and DNA cancer vaccines. Recent pacts with Vyriad and BioNTech will help push in that direction.
A year from now, Lowy said, he wants to come into ESMO showing off their proof-of-concept data for the bispecifics and new data on Libtayo in combination.
They’ll look to “belie this notion that antibodies are commodities,” he said.”Anybody can make an antibody, but making a damn good antibody is not trivial.”