Vaxcyte Says Topline Results From OPUS-1 Pivotal Adult Phase 3 Trial Of VAX-31, a 31-valent Pneumococcal Conjugate Vaccine Candidate, Met All Prespecified Primary Endpoints Across Age Groups Studied Compared To Prevnar 20 And/Or Capvaxive
VAX-31 Met All Prespecified Primary Endpoints Across Age Groups Studied Compared to Prevnar 20 (PCV20) and/or Capvaxive (PCV21)
Prespecified Co-Primary Immunogenicity Endpoints: In Adults 50 and Older, All 28 VAX-31 Serotypes Shared with PCV20 and/or PCV21 Met Noninferiority Criterion at >0.667 Threshold; All Three Serotypes Unique to VAX-31 and Cross-Reactive Serotype 20B Met Superiority Criterion
Prespecified Primary Immunobridging Endpoint: Across All 321 Serotype Comparisons, VAX-31 Met Noninferiority Criterion at >0.667 Threshold in Adults Aged 18-49 Compared with Adults Aged 50-64
Prespecified Primary Safety Endpoint: VAX-31 Was Well Tolerated and Demonstrated a Safety Profile Similar to PCV20 and PCV21 Across All Ages Studied
Prespecified Individual Comparator Results: VAX-31 Met Noninferiority Criterion at >0.667 Threshold for 20 of 20 Serotypes Shared with PCV20 and 17 of 19 Shared with PCV21, and at Historical >0.5 Threshold, VAX-31 Met Noninferiority Criterion for 19 of 19 Shared with PCV212
Company Expects to Report Results from OPUS-2 and OPUS-3 Adult Phase 3 Trials in First Half of 2027, Supporting Planned Biologics License Application Submission in First Half of 2028
Topline Results Further Validate Potential of Vaxcyte’s Carrier-Sparing Platform to Deliver Broader Coverage While Maintaining Magnitude of Immune Responses
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