On Saturday, Amgen Inc AMGN and Kyowa Kirin Co., Ltd. announced new results from the ongoing ROCKET Phase 3 trial program rocatinlimab in moderate to severe atopic dermatitis (AD).

The IGNITE study evaluated two dose strengths of rocatinlimab and met its co-primary endpoints and all key secondary endpoints versus placebo.

• At week 24, 42.3% of patients in the higher dose group achieved ≥75% reduction from baseline in Eczema Area and Severity Index score (EASI-75), a 29.5% difference vs. placebo, and 36.3% vs. 23.4% in the lower dose group.
• In the higher dose group, 23.6% of patients achieved a validated Investigator’s Global Assessment for Atopic Dermatitis score of 0 (clear) or 1 (almost clear) with a ≥2-point reduction from baseline (vIGA-AD 0/1) at week 24, representing a 14.9% difference vs. placebo.
• In the lower dose group, 19.1% of patients achieved this endpoint, a 10.3% difference vs. placebo.

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In addition, IGNITE met the endpoint of the revised Investigator’s Global (rIGA) Assessment score of 0/1 with a ≥2-point reduction from baseline.

• At week 24, 22.7% of patients in the higher dose group achieved this endpoint, a 14.4% difference vs. placebo.
• In the lower dose group, 16.3% of patients achieved this endpoint, an 8.0% difference vs. placebo.

The ROCKET program is also informed by the results of the SHUTTLE and VOYAGER studies.

• The SHUTTLE study evaluated two dose strengths of rocatinlimab in combination with topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) in 746 adults using the same co-primary endpoints as IGNITE. The study met its co-primary and all key secondary endpoints.
  • For EASI-75, 52.3% of patients in SHUTTLE’s higher dose group achieved the endpoint, a 28.7% difference vs. placebo, while 54.1% of patients in the lower dose group achieved the endpoint, a 30.4% difference vs. placebo.
  • For vIGA-AD 0/1, 26.1% of SHUTTLE patients in the higher dose group achieved the endpoint, a 13.8% difference vs. placebo. In the lower dose group: 25.8% vs. 13.5%.
  • For rIGA 0/1, 23.3% of SHUTTLE patients in the higher dose group achieved the endpoint, an 11.5% difference vs. placebo and 22.7% vs. 10.9% in the lower dose group.

The VOYAGER study demonstrated that rocatinlimab does not interfere with responses to tetanus and meningococcal vaccinations.

William Blair writes rocatinlimab results validate the OX40 mechanism, likely supporting a moderate commercial opportunity for patients after Sanofi SA SNY and Regeneron Pharmaceutical Inc’s REGN Dupixent and Eli Lilly & Co’s LLY Ebglyss.

Price Action: AMGN stock is up 2.4% at $332.90 at last check Monday.

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