Bristol Myers Squibb’s hand was forced when it had to spin-off its blockbuster immunology med Otezla to Amgen, gained via its Celgene buyout, given that it had a similar oral deucravacitinib in the pipeline.
Competition concerns prompted the move, but now BMS believes it has in it hands a better drug with which to compete.
We’ve seen the topline data from its two trials POETYK PSO-1 and POETYK PSO-2 over the past five months, but now it releasing some more details at the AAD 2021 for deucravacitinib, its oral, selective TYK2 inhibitor with a unique mechanism of action that inhibits the IL‐12, IL‐23 and Type 1 IFN pathways.
In both pivotal studies, the psoriasis drug was superior to placebo and Otezla, which has become the current oral standard of care, including in measures of durability and maintenance of response.
Specifically, deucravacitinib showed superior skin clearance compared with Otezla for key secondary endpoints, including PASI 75 and sPGA 0/1 responses at week 16, with an increased benefit versus Otezla at week 24 and maintained through week 52.
In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures. P values were not shared, leaving these results still open for deeper scrutiny; there was also a slightly higher incidence of safety issues for Bristol than Amgen, which will be closely watched.
“Deucravacitinib is an important part of our Immunology franchise, and our goal is to ensure that deucravacitinib ultimately benefits as many appropriate patients as possible, including those with moderate to severe plaque psoriasis,” said Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development at Bristol Myers Squibb.
Hirawat told Fierce Biotech that: “We are planning for regulatory submissions based on the results from the POETYK PSO-1 and POETYK PSO-2 trials as soon as possible […] We anticipate approvals and launches beginning in 2022.”
COVID and Celgene integration
Talking more broadly about the challenges of conducting these sort of studies amid a major, global pandemic, Hirawat said: “We have been fortunate that for the most part, we have been able to keep our R&D programs on track. Like most companies, we did experience a downturn in clinical trial enrollment when the pandemic first hit, but we have been able to remain on track with most of our programs.”
It’s also had to keep going whilst also integrate its $74 billion Celgene buy into its company. Giving up Otezla appeared to be a blow for that deal when it was first announced, but today’s data is something of a reprieve.
“This merger was the culmination of a long-term strategy at Bristol Myers Squibb to combine the reach and resources of an established pharmaceutical company with the agility of a biotech,” Hirawat explained.
“The integration presented a fresh opportunity to take some of the lessons from our new colleagues about simplifying how we operate and moving with greater speed, and marry them with the scale, resources and centralized capabilities that existed at Bristol Myers Squibb.”
He added that the pandemic, rather than hinder, “has accelerated certain integration activities, in particular our cultural integration, as we rallied together to respond.”