Overview
- An updated phase I analysis presented at a major cancer meeting reported a 52% confirmed response rate and 93% disease control in a 27‑patient subgroup with KRAS G12D‑mutant NSCLC treated at the selected dose.
- Median progression‑free survival reached 11.1 months in that subgroup, and the median duration of response and overall survival were not yet reached at the time of analysis.
- Safety in 40 treated patients at 1,200 mg once daily showed no grade 4 or higher treatment‑related events after 13.1 months, with grade 3 events in 13% and few dose changes or stops.
- All efficacy‑evaluable patients had prior immunotherapy and platinum chemotherapy but not docetaxel, and the FDA granted Breakthrough Therapy designation to zoldonrasib in January 2026 for this population.
- Zoldonrasib is an oral KRAS G12D‑selective inhibitor that locks the protein in its active complex with cyclophilin A to block downstream signaling, addressing a mutation seen in about 4% of lung cancers with no approved targeted therapy today.