Onco-Summaries: Daily Oncology Updates at a Glance

02/09/2025

Replimune has scheduled a Type A Meeting with the FDA for the CRL of RP1 + nivo in advanced melanoma (Ref)

Replimune announced that a Type A meeting with the US FDA has been scheduled to discuss the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with GALV-GP R- and GM-CSF) + nivolumab for the treatment of advanced melanoma.

• Replimune submitted a briefing book to the FDA addressing the points from the CRL

  
  

  • This included points on prior agreements related to the patient population, criteria for PD-1 resistance, and use of literature to support contribution of components

    
    

  • Details on additional analysis of data from the BLA have also been included along with comments about the Phase 3 confirmatory trial design being addressed

The clinical development of Zymeworks' ZW171 has been discontinued (Ref)

Zymeworks has voluntarily discontinued the clinical development of ZW171 (mesothelin-directed T cell engager) designed to target gynecological, thoracic, and digestive system cancers.

• The decision was based on completion of the planned cohorts of the dose escalation portion of the Phase 1 trial of ZW171 in ovarian cancer and NSCLC

• Zymeworks determined that further dose evaluation in the current trial would be unlikely to support a benefit-risk profile consistent with the desired monotherapy target product profile