Pyxis Oncology reports updated Phase 1 data for MICVO in head and neck cancer

Pyxis Oncology announced on September 9, 2026 updated results from its ongoing Phase 1 monotherapy study of micvotabart pelidotin (MICVO) in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma, based on an August 18, 2026 data cutoff.

In the efficacy-evaluable population of 33 patients dosed at 5.4 mg/kg intravenously every three weeks at or below a dose cap, the data demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR).¹ Median progression-free survival was 6.2 months, and the 12-month overall survival probability was 79%, while median overall survival has not yet been reached.¹ Clinical activity was observed across key patient subgroups, including HPV status and prior treatment.¹

On safety, in the 35-patient safety population, no new safety signals were observed, and dose capping reduced the frequency and severity of adverse events in high body weight patients.¹ All treatment-related adverse events occurred in 32 patients (91.4%), with grade 3 or higher TRAEs in 19 patients (54.3%) and no treatment-related deaths.¹

The company said based on feedback from the FDA and EMA on the design of its pivotal Phase 3 study, Headliner, it believes MICVO is well positioned for a randomized trial planned to begin in mid-2027.¹ That randomized, open-label, two-arm study is expected to enroll approximately 500 patients randomized 1:1 to MICVO or investigator's choice of cetuximab, docetaxel, or methotrexate,¹ with co-primary endpoints of overall response rate and overall survival.¹

Separately, Pyxis expects to report updated data from its Phase 1/2 combination study of MICVO with Merck's KEYTRUDA (pembrolizumab) in first-line R/M HNSCC patients in the fourth quarter of 2026.¹