Pyxis Oncology reported positive preliminary data from ongoing Phase 1 clinical studies on Micvotabart Pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
The study showed a confirmed objective response rate (ORR) of 46% and a disease control rate (DCR) of 92% with MICVO as monotherapy in 2L+ R/M HNSCC.
Additionally, MICVO in combination with KEYTRUDA demonstrated a confirmed ORR of 71% and a DCR of 100% in 1L/2L+ R/M HNSCC.
The company is expecting updated data from the ongoing Phase 1 studies in mid-2026, contributing to the promising results observed so far.
Pyxis Oncology is advancing MICVO as a potential novel treatment option for difficult-to-treat cancers in the R/M HNSCC landscape.
Confirmed ORR and DCR
MICVO showed a 46% confirmed ORR and 92% DCR as monotherapy in 2L+ R/M HNSCC.
Positive Combination Results
MICVO in combination with KEYTRUDA demonstrated a 71% confirmed ORR and 100% DCR in 1L/2L+ R/M HNSCC.
Ongoing Phase 1 Studies
Updated data from the ongoing Phase 1 monotherapy and Phase 1/2 combination studies are expected to be released in 2026.
Therapeutic Potential
The emerging response rates and disease control observed highlight MICVO's agility as a potential treatment option in the cancer treatment landscape.
Clinical Development Confidence
The lack of early disease progression in the studies supports confidence in MICVO's durability profile.
- The positive data from Pyxis Oncology's Phase 1 clinical studies indicate a promising outlook for MICVO in treating difficult-to-treat cancers like R/M HNSCC.
- The observed response rates and disease control figures signal a potentially effective and durable treatment option for patients in later therapy lines.
- The combination results with KEYTRUDA further emphasize the potential synergies of MICVO in enhancing treatment outcomes for head and neck squamous cell carcinoma patients.
Overall, the preliminary data from Pyxis Oncology's Phase 1 clinical studies on MICVO are highly encouraging and point towards a promising future for this novel treatment option in the management of recurrent/metastatic head and neck squamous cell carcinoma.