Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
daraxonrasib · 5 trials · 26 indications
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by Investigator.
OS is defined as the time from randomization until death from any cause.
DFS defined as the time from randomization until disease recurrence or death from any cause, whichever occurs first. Recurrence is per response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by Investigator.
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by BICR.
OS is defined as the time from randomization until death from any cause.
ORR is defined as the proportion of patients who achieved a complete response (CR) or partial response (PR) based on the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders.
Number of patients with AEs as assessed by CTCAE v5.
Number of patients with changes in vital signs.
Number of patients with changes in clinical laboratory test values.
Number of patients with dose limiting toxicities
| Arm | Type | Description |
|---|---|---|
| Arm A: daraxonrasib | EXPERIMENTAL | study drug |
| Arm B: daraxonrasib + gemcitabine and nab-paclitaxel | EXPERIMENTAL | study drug in combination with chemotherapy |
| Arm C: gemcitabine and nab-paclitaxel | ACTIVE_COMPARATOR | SOC chemotherapy |
| daraxonrasib | EXPERIMENTAL | study drug |
| SOC Observation | NO_INTERVENTION | Patients randomized to the comparator control arm will receive SOC observation. |
| docetaxel | ACTIVE_COMPARATOR | Patients randomized to the comparator control arm will receive docetaxel as the standard of care therapy. |
| Arm A: Daraxonrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion (+ Carboplatin/Cisplatin + Pemetrexed) |
| Arm B: Elironrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion. Dose Expansion will include two separate cohorts: Cohort B1 (+ daraxonrasib) and Cohort B2 (+ Carboplatin/Cisplatin + Pemetrexed). |
| Arm C: Zoldonrasib + Ivonescimab Combination | EXPERIMENTAL | Dose Exploration and Dose Expansion. Dose Expansion will include two separate cohorts: Cohort C1 and Cohort C2 (+ Cetuximab). |
| Name | Type | Description |
|---|---|---|
| daraxonrasib | DRUG | oral tablets |
| gemcitabine | DRUG | intravenous (IV) infusion |
| nab-paclitaxel | DRUG | IV infusion |
| docetaxel | DRUG | intravenous (IV) infusion |
| Elironrasib | DRUG | oral tablets |
| Zoldonrasib | DRUG | oral tablets |
| Ivonescimab | DRUG | IV infusion |
| Carboplatin/Cisplatin + Pemetrexed (Dose Expansion Only) | DRUG | IV infusion |
| cetuximab (Cohort C2 Only) | DRUG | IV infusion |
| Carboplatin/Cisplatin + Pemetrexed (Cohort B2 Only) | DRUG | IV infusion |
| Daraxonrasib (Cohort B1 only) | DRUG | oral tablets |
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed pancreatic adenocarcinoma. * Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent. * Do...
Daraxonrasib is an investigational small molecule being studied for advanced solid tumors, pancreatic cancer, biliary tract cancers, and non-small cell lung cancer (NSCLC). It is in clinical development for these oncology indications, with trials enrolling patients with RAS-mutated cancers, including pancreatic ductal adenocarcinoma and KRAS-mutant biliary tract cancer.
Daraxonrasib targets RAS proteins, specifically RAS(ON) mutants, as indicated by its classification as a RAS(ON) inhibitor. It is being studied in patients with RAS-mutated cancers, including KRAS-mutant biliary tract cancer and RAS-mutated NSCLC, to interfere with the signaling pathways driven by these mutations.
Daraxonrasib is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RVMD. The company is conducting clinical trials of Daraxonrasib across multiple oncology indications, including NSCLC and pancreatic cancer.
Daraxonrasib is in Phase 1 through Phase 3 clinical development. It has received Breakthrough Therapy and Orphan Drug designations from the FDA. While it is not yet approved, it is being evaluated in recruiting Phase 3 trials for RAS-mutated NSCLC and resected pancreatic ductal adenocarcinoma, as well as earlier-phase studies.
Daraxonrasib is being studied in four clinical trials. NCT06881784 is a Phase 3 study in RAS-mutated NSCLC, NCT07252232 is a Phase 3 study in resected pancreatic ductal adenocarcinoma, NCT07397338 is a Phase 1 combination study in solid tumors, and NCT07793253 is a Phase 2 study in recurrent KRAS-mutant biliary tract cancer.
Yes, Daraxonrasib is also known as RMC-6236. Clinical trial titles for the drug refer to it as Daraxonrasib (RMC-6236), confirming that both names refer to the same investigational agent being developed by Revolution Medicines for RAS-mutated cancers.