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NOW APPROVED
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Revolutionizing mPDAC, Breaking Barriers. A ship breaks through icebergs that reflect the many challenges in treating mPDAC and targeting RAS.
In adults with previously treated metastatic pancreatic adenocarcinoma; RASolute 302 was a Phase 3 trial evaluating the efficacy and safety of RASONQUE monotherapy vs SOC combination chemotherapy.
The first and only approved RAS(ON) multi-selective inhibitor that is redefining the standard of care in mPDAC
RASolute 302 was a Phase 3 trial evaluating the efficacy and safety of RASONQUE monotherapy vs SOC combination chemotherapy in adults with previously treated metastatic pancreatic adenocarcinoma.1,2
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The first and only approved RAS(ON) multi-selective inhibitor that is redefining the standard of care in mPDAC1,2*
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In RASolute 302
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Unprecedented overall survival (OS) was observed in patients, regardless of RAS mutation status1,3
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RASolute 302 was a global, randomized, head-to-head, open-label, Phase 3 trial evaluating the efficacy and safety of RASONQUE monotherapy vs SOC combination chemotherapy† in adult patients with metastatic pancreatic adenocarcinoma who had received at least 1 prior systemic therapy.1,2
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Primary endpoints1,2
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OS
(RAS G12 POPULATION)
RASONQUE
(n=228)
SOC combination chemotherapy†
(n=231)
mOS
13.2 months
6.6 months
HR=0.40 (95% CI: 0.30, 0.54)‡; p<0.0001§
PFS
(RAS G12 POPULATION)
RASONQUE
(n=228)
SOC combination chemotherapy†
(n=231)
mPFS
7.3 months
3.5 months
HR=0.45 (95% CI: 0.34, 0.59)‡; p<0.0001§
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Secondary endpoint1
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OS (ITT POPULATION)
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13.2 months median OS with RASONQUE (95% CI: 10.0, NE) (N=248) versus 6.7 months median OS with SOC combination chemotherapy (95% CI: 5.8, 8.0) (N=252). 60% reduction in the risk of death (HR=0.40 [95% CI: 0.30, 0.53] dagger; p<0.0001^double dagger).
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*RASONQUE is an inhibitor of the RAS GTPase family. RASONQUE binds to cyclophilin A, resulting in a binary complex that binds to the active, GTP-bound state of RAS.1
†SOC combination chemotherapy included mFOLFIRINOX, gemcitabine + nab-paclitaxel, FOLFOX, or liposomal irinotecan + 5-FU/leucovorin.1
‡Based on the stratified Cox proportional hazard model.1
§Two-sided p-value based on stratified log-rank test.1,2
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Approved for all adult patients with mPDAC who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy1
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Clinical trial results
See clinical data from RASolute 302
Detailed data
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RASONQUE ordering
How to order RASONQUE for your patients
Ordering information
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5-FU=5-fluorouracil; CI=confidence interval; FOLFOX=leucovorin + 5-FU + oxaliplatin; HR=hazard ratio; ITT=intent-to-treat; mFOLFIRINOX=modified leucovorin + 5-FU + irinotecan + oxaliplatin; mOS=median overall survival; mPDAC=metastatic pancreatic adenocarcinoma; mPFS=median progression-free survival; NE=not estimable; RAS=rat sarcoma; SOC=standard of care.
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References: 1. RASONQUE. Prescribing information. Revolution Medicines, Inc.; 2026. 2. O’Reilly EM, Wainberg ZA, Hendifar AE, et al; RASolute 302 Trial Investigators. Daraxonrasib or chemotherapy in previously treated metastatic pancreatic cancer. N Engl J Med. Published online May 31, 2026. doi:10.1056/NEJMoa2605555 3. Katayama ES, Hue JJ, Bajor DL, et al. A comprehensive analysis of clinical trials in pancreatic cancer: what is coming down the pike? Oncotarget. 2020;11(38):3489-3501. doi:10.18632/oncotarget.27727
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