Shots:
- FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review
- Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs PBO & CT in treatment-naïve SCAC pts & P-II (POD1UM-202) trial evaluating Zynyz monotx. in treatment-experienced SCAC pts progressing on or intolerant to Pt-based CT
- P-III trial showed a 37% PFS improvement (mPFS: 9.3 vs 7.4mos.) & a 6.2mos. mOS gain as shared at ESMO 2024; OS follow-up is ongoing while P-II showed 14% ORR & 49% DCR with Zynyz monotx.
Ref: Incyte | Image: Incyte| Press Release
Related News:- Incyte Reports Topline Data from P-III (STOP-HS1 & STOP-HS2) Trials of Povorcitinib (INCB054707) for Hidradenitis Suppurativa (HS)
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