Therapy Detail
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| Therapy Name | Daraxonrasib |
| Synonyms | |
| Therapy Description |
Daraxonrasib (RMC-6236) forms a binary complex with CypA, which prevents GTP-bound RAS from interacting with downstream effectors, potentially leading to anti-tumor activity (Cancer Res 2022;82(12_Suppl): Abstract nr 3597, PMID: 38593348). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Daraxonrasib | RMC 6236|RMC6236|RMC-6236 | RAS Inhibitor (Pan) 14 | Daraxonrasib (RMC-6236) forms a binary complex with CypA, which prevents GTP-bound RAS from interacting with downstream effectors, potentially leading to anti-tumor activity (Cancer Res 2022;82(12_Suppl): Abstract nr 3597, PMID: 38593348). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| HRAS G12X | pancreatic ductal adenocarcinoma | sensitive | Daraxonrasib | Phase III | Actionable | In a Phase III trial (RASolute 302), treatment with Daraxonrasib (RMB-6236) in patients with metastatic pancreatic ductal adenocarcinoma significantly improved median overall survival (mOS, 13.2 vs 6.6 mo, HR=0.40, p<0.001) and median progression-free survival (mPFS, 7.3 vs 3.5 mo, HR=0.45, p<0.001) compared to chemotherapy in patients harboring a RAS G12 mutation, and mOS (13.2 vs 6.7 mo, HR=0.40, p<0.001) and mPFS (7.2 vs 3.6 mo, HR=0.49, p<0.001) in the overall cohort (PMID: 42223072; NCT06625320). | 42223072 |
| NRAS G12X | pancreatic ductal adenocarcinoma | sensitive | Daraxonrasib | Phase III | Actionable | In a Phase III trial (RASolute 302), treatment with Daraxonrasib (RMB-6236) in patients with metastatic pancreatic ductal adenocarcinoma significantly improved median overall survival (mOS, 13.2 vs 6.6 mo, HR=0.40, p<0.001) and median progression-free survival (mPFS, 7.3 vs 3.5 mo, HR=0.45, p<0.001) compared to chemotherapy in patients harboring a RAS G12 mutation, and mOS (13.2 vs 6.7 mo, HR=0.40, p<0.001) and mPFS (7.2 vs 3.6 mo, HR=0.49, p<0.001) in the overall cohort (PMID: 42223072; NCT06625320). | 42223072 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06625320 | Phase III | Fluorouracil + Leucovorin + Liposomal irinotecan Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel Daraxonrasib | Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | 2 |
| NCT06881784 | Phase III | Docetaxel Daraxonrasib | Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) (RASolve 301) | Recruiting | USA | POL | NZL | NLD | ITA | IRL | GBR | FRA | ESP | DEU | CHE | BEL | AUS | 6 |
| NCT05379985 | Phase I | Daraxonrasib | Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS | Recruiting | USA | 0 |
| NCT07491445 | Phase III | Gemcitabine + Nab-paclitaxel Daraxonrasib Daraxonrasib + Gemcitabine + Nab-paclitaxel | Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma (RASolute 303) | Recruiting | USA | 0 |
| NCT07252232 | Phase III | Daraxonrasib | Study of Daraxonrasib (RMC-6236) in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 304) | Recruiting | USA | GBR | 1 |
| NCT06128551 | Phase Ib/II | RMC-6291 Daraxonrasib Daraxonrasib + RMC-6291 | Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors | Recruiting | USA | NLD | ITA | FRA | ESP | DEU | 1 |
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