Pyxis Oncology Announces Positive Updated Data from Phase 1 Monotherapy Study of Micvotabart Pelidotin (MICVO) in Second-Line and Beyond Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (2L+ R/M HNSCC)
Pyxis Oncology reported updated Phase 1 monotherapy data for its lead ADC micvotabart pelidotin (MICVO) in 2L+ recurrent/metastatic head and neck squamous cell carcinoma, showing a 36% confirmed objective response rate and 94% disease control rate in 33 efficacy-evaluable patients dosed at 5.4 mg/kg with a dose cap. Median progression-free survival was 6.2 months and the 12-month overall survival probability was 79%, with median OS not yet reached; no new safety signals were observed and there were zero treatment-related deaths among 35 safety-evaluable patients, though 54.3% had Grade ≥3 TRAEs.
Key figures
- Drug Name
- micvotabart pelidotin (MICVO, formerly PYX-201)
- Phase Of Trial
- Phase 1 monotherapy dose expansion; pivotal Phase 3 (Headliner) planned
- Dose
- 5.4 mg/kg IV Q3W with dose cap
- Median os
- not reached (NR)
- Confirmed orr
- 36% (12/33)
- Median pfs months
- 6.2
- Phase3 initiation
- mid-2027
- Safety evaluable n
- 35
- Grade3plus trae pct
- 54.3%
- Disease control rate
- 94% (31/33)
- Efficacy evaluable n
- 33
- Treatment related deaths
- 0
- End of phase2 fda meeting
- Q1 2027
- Phase3 planned enrollment
- 500
- Twelve month os probability
- 79%
- Keytruda combo data expected
- Q4 2026
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