Regeneron may have been the 6th biopharma company to land an initial approval for a PD-1/L1 therapy, but they’re clearly not settling for anything close to a last-place finish in the amazing race for market dominance in the mega-blockbuster field.
In their Q4 call with analysts on Thursday, Regeneron’s not-shy R&D chief George Yancopoulos touted their capture of the lead role among checkpoints in treating advanced cutaneous squamous cell carcinoma. In an interview with Endpoints News last month, Yancopoulos made so secret of his opinions about the PD-L1s on the market, slamming them all as second-rate and assigning worst-in-class status to Bavencio from Pfizer and Merck KGaA. But they’re also moving to challenge giant Merck’s Keytruda — another PD-1 — on one of its major achievements: winning an OK as a monotherapy for frontline use in non-small cell lung cancer.
Here’s Yancopoulos from the call on his I/O strategy:
(W)e have doubled the size of our trial comparing Libtayo monotherapy to chemotherapy in PD-L1-high patients. Regarding combinations, we’ll be focusing our efforts in first-line treating and combination therapy of Libtayo with chemotherapy. The ongoing Phase III combination study is being augmented to enroll non-small cell lung cancer patients irrespective of histology and the levels of PD-L1 expression and to randomize to Libtayo plus chemotherapy or chemotherapy alone.
Amazingly enough despite the years of effort in many pivotal trials there’s only one PD-1 or PD-L1 antibody approved as monotherapy in first-line metastatic non-small cell lung cancer (Keytruda). If our ongoing trials succeed, we have the potential to be the second.
Bristol-Myers Squibb — which so far has provided Keytruda its biggest challenge with Opdivo — has been working hard to overcome Merck’s move to the top of the market, focusing on a tumor mutational burden approach that has failed to gain much traction.
Yancopoulos was also quick to tout Regeneron’s bispecific strategy, focusing on: “the CD3 bispecifics and the costimulatory bispecifics. We believe that these bispecifics may have important anticancer activity on their own and in combinations that can include Libtayo.… Many of our CD3 bispecifics are already in the clinic with one of them showing impressive initial results as a monotherapy in very-advanced late-stage patients.”
“REGN1979 our CD20xCD3 bispecific for B-cell Non-Hodgkin’s Lymphoma or NHL” has achieved impressive results, he noted, adding:
(O)ur BCMAxCD3 bispecific antibody has just entered clinical development for the treatment of multiple myeloma. We’re encouraged by preliminary results of both CAR-T as well as BiTEs targeting BCMA in multiple myeloma and believe that our BCMAxCD3 bispecific has a potential of being an important addition in this new area.
“It’s us against the world,” Yancopoulos told me in a meeting at JP Morgan. And the Regeneron research chief gives the company good odds at winning, citing his clear belief that the company has the best technology and drugs in hand to slam dunk the competition.
Image: George Yancopoulos. GETTY IMAGES
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