Pyxis Oncology reports 36% cORR, 94% DCR for MICVO in 2L+ HNSCC; Phase 3 planned mid-2027

Pyxis Oncology, Inc.

MICVO Phase 1 in 2L+ R/M HNSCC: cORR 36% (12/33), DCR 94% (31/33), mPFS 6.2 months, 12-month OS 79%.
Median OS not reached; 83% of responders had >50% tumor reduction; 75% responded by first scan at 6 weeks.
No new safety signals; dose capping reduced frequency/severity of AEs in high body weight patients; no treatment-related deaths.
Phase 3 Headliner trial planned to initiate mid-2027; FDA/EMA aligned on design; End of Phase 2 meeting Q1 2027.
Combination with KEYTRUDA data expected Q4 2026; updated OS data from monotherapy expected H1 2027.

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