Amgen’s $400 million eczema drug candidate has recorded two more phase 3 victories. The data drops provide more evidence that the Kyowa Kirin-partnered rocatinlimab improves outcomes in atopic dermatitis, but questions about the positioning of the anti-OX40 antibody versus Sanofi and Regeneron’s Dupixent remain unanswered.
Last year, Amgen and Kyowa shared the first data from its broad phase 3 rocatinlimab program. The study met its primary endpoint, but analysts compared the results unfavorably to the data on Dupixent. Adjusted for placebo, 19.1% of people on rocatinlimab had 75% improvement in eczema area and severity after 24 weeks of treatment. The comparable figures from Dupixent trials are as high as 36% after 16 weeks.
Amgen sees an opportunity for a drug with a different mechanism of action, citing evidence about how often patients stop or switch therapies. Saturday, the Big Biotech and Kyowa presented results to make the case that rocatinlimab can seize that opportunity.
The latest data come from Ignite and Shuttle, two trials from Amgen and Kyowa’s broader Rocket program. Ignite randomized 769 adults with moderate to severe eczema, including an undisclosed number of patients previously treated with a biologic or systemic JAK inhibitor, to receive one of two doses of rocatinlimab or placebo. The high dose was identical to the only dose used in the earlier phase 3 trial.
On the high dose, 42.3% of patients met the 75% improvement criteria, EASI-75. The placebo-adjusted EASI-75 was 29.5%. The lower dose was less effective, but the result was still numerically higher than in the earlier phase 3, with a placebo-adjusted difference of 23.4%. Jefferies analysts said in a note to investors that the results are “optically more compelling” than the earlier data.
The other study, Shuttle, randomized 746 adults with moderate to severe eczema to receive one of two doses of rocatinlimab or placebo. Again, the high dose was the same dose used in the earlier phase 3 trial. Participants in Shuttle also received topical corticosteroids and/or topical calcineurin inhibitors. The placebo-adjusted EASI-75 results were 28.7% and 30.4%, respectively, on the low and high doses.
Amgen, which paid Kyowa $400 million upfront for rights to rocatinlimab in 2021, also reported wins on two versions of an investigator eczema assessment scale in Ignite and Shuttle. Safety was generally consistent with the profile seen in earlier studies, according to Amgen and Kyowa.
“In totality, the rocatinlimab results validate the OX40 mechanism, likely supporting a moderate commercial opportunity for patients after Dupixent/Ebglyss,” William Blair analysts said in a March 10 note.
However, the readouts “still leave potential room for improvement with future OX40/OX40L targeting therapies,” added the analysts, pointing to Inmagene's OX40-targeting monoclonal antibody IMG-007.
Three more readouts are coming up. Amgen and Kyowa are aiming to publish phase 3 results from Ascend, a trial that is assessing dosing beyond 24 weeks, and the adolescent Astro study in the second half of the year. A second trial in adolescent patients, Orbit, is underway, as are phase 2 and 3 trials in asthma and prurigo nodularis. The studies are testing the idea that rocatinlimab rebalances the T-cell compartment.