Zoldonrasib (RMC-9805) is an investigational RAS(ON) G12D-selective inhibitor in late-stage oncology development for KRAS G12D-mutated cancers. It has shown encouraging early clinical activity in NSCLC and pancreatic cancer settings and has progressed into multiple Phase 3 programs. FDA granted Breakthrough Therapy Designation in January 2026 for previously treated KRAS G12D-mutated advanced/metastatic NSCLC.
Updated phase I data showed zoldonrasib produced a 52% confirmed objective response rate and 93% disease control rate in previously treated KRAS G12D-mutant NSCLC. No grade 4 or higher treatment-related adverse events were observed at the recommended phase II dose.
Tango Therapeutics said it plans to start a pivotal 300-patient randomized vopimetostat trial in second-line pancreatic cancer this year after FDA interactions. The company also reported early combination enrollment with daraxonrasib and zoldonrasib and said more monotherapy and combination data are expected later this year.
Pharmaceutical M&A is shifting toward late-stage clinical assets with proven human data, particularly in GLP-1 obesity drugs, oncology, and central nervous system disorders. Companies like Viking Therapeutics, Structure Therapeutics, and Revolution Medicines represent compelling acquisition targets with advanced clinical programs. This trend reflects industry prioritization of de-risked assets that can accelerate commercialization pathways.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07397338 |
Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors |
RECRUITING | PHASE1/PHASE2 |
