Bristol Myers' next-gen immunology med busts Amgen's Otezla in head-to-head study. Is a showdown coming?
In an immunology market packed with blockbuster biologics, Bristol Myers Squibb hopes that its oral drug for milder cases could carve out a lucrative foothold. Now, with its eyes set on busting Amgen’s Otezla, the drugmaker is rolling out full data from a pair of late-stage studies that bode well for its candidate.
Bristol Myers’ TYK2 inhibitor deucravacitinib significantly cut psoriasis patients’ disease activity and spurred clearer skin at four months than patients dosed with Amgen’s Otezla or placebo, according to data from two Phase III studies presented Friday at the virtual American Academy of Dermatology meeting.
In terms of PASI 75, a measure of disease severity, 58.7% and 53.6% of patients on deucravacitinib achieved PASI 75 response respectively, in the POETYK-PSO-1 and POETYK-PSO-2 studies. Meanwhile, just 12.7% and 9.4% of placebo patients and 35.1% and 40.2% of patients on Otezla achieved the same.
Even more promising for Bristol Myers, deucravacitinib maintained its edge over Otezla between 24 and 52 weeks of treatment. At the six-month check-in, 69.0% and 59.3% of patients on deucravacitinib hit PASI 75 versus 38.1% and 37.8% on Otezla. Of those deucravacitinib patients who hit the PASI 75 mark at six months, 82.5% and 81.4% maintained that response at the one-year check in.
Deucravacitinib showed similarly higher rates of skin clearance than placebo and Otezla with a slightly higher rate of severe side effects than Amgen’s drug.
Bristol Myers is calling the results significant even though the data didn’t come with p-values. Either way, it’s a strong showing from its drug, a TYK2 inhibitor Bristol Myers hopes will usher in a next generation of immunology meds.
The drugmaker uncorked top-line data from these studies back in February, highlighting deucravacitinib’s important role in driving the company’s pipeline success. At JP Morgan in January, Bristol Myers touted the drug as one of four major blockbuster programs in the pipeline with the potential to earn more than $4 billion a year. The other three were mavacamten, acquired in the MyoKardia buyout, along with the anemia drug Reblozyl and the cancer cell therapy franchise.
Unlike the biologics that have come to dominate the market, Bristol Myers is aiming deucravacitinib at milder patients who prefer a more convenient oral dose. Researchers hope the TYK2 pathway will offer a safer alternative than the JAK class, which has been dogged by safety flags since its inception. The case in point there is Pfizer’s Xeljanz, which has failed to capitalize on its early promise with a black box warning for thrombosis and serious infections, among other things.