Jefferies analysts expect a regulatory filing for rocatinlimab later this year, with a product launch in 2026.
Amgen and Kyowa Kirin established the long-term safety and durable efficacy of their investigational antibody rocatinlimab in a Phase III atopic dermatitis extension study, further derisking the asset for approval.
The partners did not provide specific data in their topline readout on Tuesday, announcing only that over 56 weeks—24 weeks of initial treatment plus 32 weeks of long-term follow-up—the rate of dropouts was “low” across all treated groups. Common side effects included upper respiratory infections, flu, aphthous ulcers and cough.
In terms of efficacy, patients who initially saw improvements from rocatinlimab and stayed on treatment “reported continued therapeutic benefit at one year of treatment across measures of improvement in skin clearance, itch, disease extent and severity,” according to a joint news release on Tuesday.
Jefferies analysts called Tuesday’s results “limited,” noting the lack of “statistical details.” Nevertheless, the findings “demonstrated favorable long-term safety” and showed that rocatinlimab can “sustain skin improvement and itch relief.”
“The trial therefore succeeded in demonstrating durability of response,” Jefferies wrote, adding that the readout “improves our confidence in Roca’s approvability.” The companies are planning to file for rocatinlimab’s approval for atopic dermatitis this year, the analysts noted, estimating a product launch next year.
Rocatinlimab, one of several products in Amgen’s pipeline that analysts have been closely watching, is an anti-OX40 receptor antibody that works by suppressing systemic and local inflammatory responses. In 2021, Amgen committed $400 million upfront to partner with Kyowa Kirin on its development. According to Tuesday’s release, the asset reduces pathogenic effective and memory T cells, in turn restoring the balance of T cells in patients with atopic dermatitis. Amgen and Kyowa Kirin tested rocatinlimab in the Phase III ROCKET program, consisting of several trials.
Tuesday’s data come from the Phase III ASCEND trial, a long-term extension trial that enrolled some 2,600 patients who had graduated from ROCKET. ASCEND, according to the news release, is “descriptive in nature” and is designed to primarily assess long-term safety.
In March, the partners reported data from the IGNITE study, demonstrating that more than 40% of patients treated with 300-mg rocatinlimab achieved at least a 75% reduction in scores in the eczema area and severity index after 24 weeks. In September last year, HORIZON found that 32.8% of patients achieved this endpoint—a finding that Jefferies analysts at the time called “modest.”
Elsewhere in the atopic dermatitis space, Sanofi last week announced that its own OX40 blocker amlitelimab resulted in significant skin lesion and disease severity improvements, though its efficacy left analysts disappointed. Amlitelimab fell “well below expectations,” Leerink Partners said at the time, noting that the magnitude of its effect “was meaningfully inferior” to Dupixent.
As for Dupixent—co-owned by Sanofi and Regeneron—the blockbuster antibody in June demonstrated significant efficacy even in patients with darker skin tones, a key atopic dermatitis subpopulation that tends to suffer from heavier disease burden and more severe symptoms.
