Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as RMC-6291
Elironrasib · 3 trials · 10 indications
Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs and vital signs
Number of participants with dose limiting toxicities
Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5
Number of patients with clinically significant changes in vital signs
Number of patients with clinically significant changes in clinical laboratory test values
Number of participants with dose limiting toxicities
Number of patients with clinically significant changes in ECGs
Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR)
| Arm | Type | Description |
|---|---|---|
| Subprotocol A: KRAS G12C-Mutated Solid Tumors | EXPERIMENTAL | RMC-6291 (BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W) |
| Subprotocol B: RAS-mutated NSCLC | EXPERIMENTAL | RMC-6236 (QD) and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W) |
| Subprotocol C: RAS G12D-mutated NSCLC | EXPERIMENTAL | RMC-9805 (QD or BID), RMC-6236 (QD), and Pembrolizumab (Q3W) with or without Chemotherapy (Q3W). |
| Subprotocol D: RAS G12D-mutated NSCLC | EXPERIMENTAL | RMC-9805 (QD) |
| Elironrasib Monotherapy | EXPERIMENTAL | Phase 2 only |
| Daraxonrasib Monotherapy | EXPERIMENTAL | Phase 2 only |
| Daraxonrasib + Elironrasib Combination | EXPERIMENTAL | Phase 1b and 2 |
| RMC-6291 | EXPERIMENTAL | Dose Escalation and Dose Expansion |
| Name | Type | Description |
|---|---|---|
| RMC-6291 | DRUG | Oral tablet |
| RMC-6236 | DRUG | Oral tablet |
| Pembrolizumab | DRUG | IV Infusion |
| Cisplatin | DRUG | IV Infusion |
| Carboplatin | DRUG | IV Infusion |
| Pemetrexed | DRUG | IV infusion |
| RMC-9805 | DRUG | Oral Tablet |
| Elironrasib | DRUG | oral tablets |
| Daraxonrasib | DRUG | oral tablets |
Inclusion criteria: All Patients (unless otherwise noted): * ≥ 18 years of age * ECOG PS is 0 to 1 * Adequate organ function as outlined by the study * Received prior standard therapy appropriate for tumor type and stage * Must have pathologically documented, locally advanced or metastatic KRAS G1...
Elironrasib is an investigational oral therapy being studied for advanced KRAS G12C-mutated solid tumors, with non-small cell lung cancer (NSCLC) as its lead indication. It is also being evaluated in colorectal cancer and pancreatic ductal adenocarcinoma. It has not been approved for any use and remains in clinical development.
Elironrasib targets KRAS G12C, a mutant form of the KRAS protein. It is a small molecule designed to inhibit the RAS(ON) active state of this mutant protein. Targeting the active, GTP-bound form distinguishes it from earlier KRAS G12C inhibitors that bind the inactive state.
Elironrasib is being developed by Revolution Medicines, Inc., a clinical-stage oncology company that trades on the Nasdaq under the ticker RVMD. The company is running the Phase 1 program for the drug both as a monotherapy and in combination with its other RAS(ON) inhibitor, daraxonrasib.
Elironrasib is in Phase 1 clinical development. It is investigational and has not received FDA approval. The FDA has granted it Breakthrough Therapy designation, a status intended to expedite development and review of drugs for serious conditions where preliminary clinical evidence suggests substantial improvement over available therapies.
Elironrasib is being studied in three Phase 1 trials: NCT06162221 in advanced RAS-mutated NSCLC, NCT06128551 testing it with daraxonrasib in advanced KRAS G12C mutant solid tumors, and NCT05462717, a monotherapy dose escalation and expansion study in advanced KRAS G12C mutant solid tumors. All three are recruiting or active.
Yes, Elironrasib and RMC-6291 refer to the same investigational drug. RMC-6291 is the earlier research code used by Revolution Medicines, while Elironrasib is the international nonproprietary name. Both names appear in the clinical trial listings for the same KRAS G12C-targeted compound.