Amgen posts results for three rocatinlimab Phase 3 trials, plus CodeBreak300 and AMG 133 updates

Amgen this week posted results for three completed rocatinlimab Phase 3 studies in atopic dermatitis and logged updates on two other programs.

• ROCKET-Orbit, a Phase 3 open-label study of rocatinlimab (AMG 451) in adolescents aged 12 to less than 18 with moderate-to-severe atopic dermatitis, is completed with results posted. Among 187 participants, 4 of 187 participants experienced treatment-emergent serious adverse events¹ over a median treatment duration of about 52 weeks.
• ROCKET-Ignite, a Phase 3, 24-week, randomized, placebo-controlled trial of rocatinlimab monotherapy in adults with moderate-to-severe atopic dermatitis, is completed with results first posted this week. The study enrolled 769 participants² and its primary outcomes were the proportion achieving vIGA-AD 0/1 response and the proportion achieving EASI 75 at Week 24.
• ROCKET-VOYAGER, a Phase 3, 24-week, randomized, placebo-controlled study of rocatinlimab's effect on vaccine antibody response in adults with moderate-to-severe atopic dermatitis, is completed with results posted. Positive anti-tetanus response at Week 24 was 92.3% with placebo versus 87.6% with rocatinlimab, and positive anti-meningococcal response was 53.2% with placebo versus 52.5% with rocatinlimab³; serious adverse events occurred in 0 of 68 placebo participants and 3 of 128 rocatinlimab participants³.
• CodeBreak300, a Phase 3 trial of sotorasib plus panitumumab versus investigator's choice in previously treated KRAS p.G12C-mutated metastatic colorectal cancer, is listed as completed with a primary completion date of July 16, 2025. The study enrolled 160 participants⁴ with progression-free survival by RECIST v1.1 as the primary outcome.
• A Phase 1 bioavailability study of AMG 133 (maridebart cafraglutide, MariTide) in people with overweight or obesity is completed. The trial enrolled 154 participants⁵ and compared pharmacokinetics of a single subcutaneous dose using a liquid drug product in vial compared to a frozen liquid drug product in vial⁵.