Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
Summary
The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to standard(s) of care (SOC) treatment.
Timeline
- Start
- 2024-10-16
- Primary completion
- 2026-06
- Completion
- 2027-12
Outcome
Met primary endpoint
paper The median overall survival in the RAS G12 population was 13.2 months with daraxonrasib and 6.6 months with chemotherapy PMID 42223072 ↗
paper the hazard ratio was 0.40 in both populations (P<0.001). PMID 42223072 ↗
paper The median progression-free survival in the RAS G12 population was 7.3 months with daraxonrasib and 3.5 months with chemotherapy PMID 42223072 ↗
paper the hazard ratios were 0.45 and 0.49, respectively (P<0.001 for both comparisons). PMID 42223072 ↗
release “an unprecedented overall survival (OS) benefit with daraxonrasib from the RASolute 302 clinical trial” revmed.com ↗
release “Trial met all primary and key secondary endpoints, including progression-free survival and overall survival” revmed.com ↗
release “In the randomized Phase 3 RASolute 302 trial, once-daily oral daraxonrasib demonstrated unprecedented improvements in overall survival (OS) and progression-free survival (PFS)” revmed.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | IRINOTECAN | Small molecule | — | Intravenous |
| Comparator | Irinotecan | Small molecule | — | Intravenous |
| Comparator | Leucovorin | Small molecule | — | Intravenous |
| Comparator | Nab-paclitaxel | Small molecule | — | Intravenous |
| Comparator | Oxaliplatin | Small molecule | — | Intravenous |
| Subject | daraxonrasib | Small molecule | — | Oral |
| Comparator | fluorouracil | Small molecule | — | Intravenous |