Pyxis Oncology reports 36% response rate for MICVO in head and neck cancer trial
Pyxis Oncology (Nasdaq: PYXS) reported updated Phase 1 monotherapy data for micvotabart pelidotin (MICVO) in second-line and beyond recurrent or metastatic head and neck squamous cell carcinoma, with a data cutoff of August 18, 2026. The company reported a 36% confirmed objective response rate among 33 efficacy-evaluable patients and said no new safety signals were observed, but 54.3% of the 35 safety-evaluable patients had treatment-related adverse events of grade 3 or higher. The company plans to initiate a pivotal Phase 3 study in mid-2027.
Key points
- Confirmed objective response rate of 36% (12 of 33) and disease control rate of 94% (31 of 33)
- Median progression-free survival of 6.2 months; 12-month overall survival probability of 79%; median overall survival not yet reached
- Grade 3 or higher treatment-related adverse events in 54.3% of patients (19 of 35); 5 patients (14.3%) discontinued treatment due to these events
- End of Phase 2 meeting with the FDA expected in the first quarter of 2027; Phase 3 Headliner trial planned to start in mid-2027
The filing
Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 09, 2026.
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