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Efficacy

RASONQUE (daraxonrasib) demonstrated unprecedented improvements in OS and PFS vs SOC combination chemotherapy.1

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Overall survival

Subgroup data

Progression-free survival

Tumor response

Additional data

Patient-reported outcomes

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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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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
OS (ITT POPULATION)
OS was a secondary endpoint 1 in the ITT population: 13.2 months median OS with RASONQUE (95% CI: 10.0, NE) versus 6.7 months median OS with SOC combination chemotherapy (95% CI: 5.8, 8.0). 60% reduction in the risk of death (HR=0.40 [95% CI: 0.30, 0.53]^dagger; p&lt;0.0001^double dagger).
OS was a secondary endpoint 1 in the ITT population: 13.2 months median OS with RASONQUE (95% CI: 10.0, NE) versus 6.7 months median OS with SOC combination chemotherapy (95% CI: 5.8, 8.0). 60% reduction in the risk of death (HR=0.40 [95% CI: 0.30, 0.53]^dagger; p&lt;0.0001^double dagger).
HR=0.40 (95% CI: 0.30, 0.53)†; p<0.0001‡
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More than half of patients receiving RASONQUE were still alive at 12 months2§
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The longest mOS observed in a Phase 3 metastatic pancreatic adenocarcinoma trial1-13||
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At the time of data cutoff (February 10, 2026), 105 patients (42.3%) continued to receive RASONQUE and 35 (13.9%) continued to receive SOC combination chemotherapy.2

*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

§The 12-month OS was 53.2% in the RASONQUE group and 17.3% in SOC combination chemotherapy group.2

||As of May 31, 2026.2

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Additional data from RASolute 302
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OS results across prespecified subgroups14

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OS analysis by subgroup was not evaluated for statistical significance. Small patient numbers can be a limitation of subgroup analyses. These analyses are provided as descriptive clinical information only.
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Additional data from RASolute 302: Forest plot of OS results across prespecified subgroups.
Additional data from RASolute 302: Forest plot of OS results across prespecified subgroups.
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The size of circles for each HR is relative to the size of the population in each subgroup.
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*HRs and 95% CIs were based on the stratified Cox model with Efron’s method of tie handling.14

†Three patients (including 2 patients randomized to the RASONQUE arm and 1 patient randomized to the chemotherapy arm) had ECOG PS >1 at baseline. These patients were not dosed due to no longer meeting trial eligibility criteria.14

‡Nine patients in the RASONQUE group and 7 patients in the chemotherapy group had no identified RAS mutation.2

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In RASolute302
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mPFS was doubled with RASONQUE1

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More than half of patients receiving RASONQUE were still alive and progression free at 6 months2*
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Secondary endpoint1
PFS (ITT POPULATION)
PFS was a secondary endpoint 1 in the ITT population: 7.2 months median PFS with RASONQUE (95% CI: 5.7, 7.5) versus 3.6 months median PFS with SOC combination chemotherapy (95% CI: 2.9, 4.2). 51% reduction in the risk of disease progression or death (HR=0.49 [95% CI: 0.38, 0.64]^dagger; p&lt;0.0001^double dagger).
PFS was a secondary endpoint 1 in the ITT population: 7.2 months median PFS with RASONQUE (95% CI: 5.7, 7.5) versus 3.6 months median PFS with SOC combination chemotherapy (95% CI: 2.9, 4.2). 51% reduction in the risk of disease progression or death (HR=0.49 [95% CI: 0.38, 0.64]^dagger; p&lt;0.0001^double dagger).
HR=0.49 (95% CI: 0.38, 0.64)†; 
p<0.0001‡
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*The 6-month PFS was 56.0% in the RASONQUE group and 32.9% in the SOC combination chemotherapy group.2

†Based on the stratified Cox proportional hazard model.1

‡Two-sided p-value based on stratified log-rank test.1

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In RASolute302
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Objective response rate (ORR) was nearly tripled with RASONQUE1*

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A 20.4% increase in ORR was seen with RASONQUE vs SOC combination therapy (95% CI: 13.3, 27.6; p<0.0001).1
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Secondary endpoint1
ORR (ITT POPULATION)
ORR was a secondary endpoint 1 in the ITT population: 31.6% ORR with RASONQUE (n=237) (95% CI: 25.8, 38.0) includes 1.3% CR and 30.4% PR. 11.2% ORR with SOC combination chemotherapy (n=241) (95% CI: 7.5, 15.9) includes 0.8% CR and 10.4% PR.
ORR was a secondary endpoint 1 in the ITT population: 31.6% ORR with RASONQUE (n=237) (95% CI: 25.8, 38.0) includes 1.3% CR and 30.4% PR. 11.2% ORR with SOC combination chemotherapy (n=241) (95% CI: 7.5, 15.9) includes 0.8% CR and 10.4% PR.
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  • Median time to response was 1.9 months in both arms1

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RASONQUE delivered a clinically meaningful response across multiple measures2
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*Assessed by BICR in patients with measurable disease at baseline.1
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CR=complete response; PR=partial response.
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Additional data from RASolute 302
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Individual best overall response1,14

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  • Disease control rate (DCR) was 79.7% with RASONQUE and 49.8% with
SOC combination chemotherapy1,14

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Individual best overall response was not evaluated for statistical significance. This analysis is provided as descriptive clinical information only.
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SD, defined as neither sufficient tumor shrinkage to qualify for PR nor sufficient tumor increase to qualify for PD, is not a component of ORR and can reflect the natural progression of disease rather than a direct therapeutic effect. SD may not be directly correlated to efficacy outcomes, and no conclusions of statistical significance can be drawn.15
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Assessment of DCR was a post hoc analysis. DCR is defined as CR + PR + SD. DCR may not be directly correlated to efficacy outcomes, and no conclusions of statistical significance can be drawn.15
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PD=progressive disease; SD=stable disease.
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Additional data from RASolute 302
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Median time to deterioration (TTD) in pain in the ITT population^2 dagger double dagger: 9.2 months with RASONQUE (N=248) and 3.8 months with SOC combination chemotherapy (N=252) HR=0.51 (95% CI: 0.37, 0.71).
Median time to deterioration (TTD) in pain in the ITT population^2 dagger double dagger: 9.2 months with RASONQUE (N=248) and 3.8 months with SOC combination chemotherapy (N=252) HR=0.51 (95% CI: 0.37, 0.71).
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Median TTD in global health status–QOL in the ITT population^ 2 section mark parallel lines: 5.7 months with RASONQUE (N=248) and 2.6 months with SOC combination chemotherapy (N=252) HR=0.60 (95% CI: 0.46, 0.79).
Median TTD in global health status–QOL in the ITT population^ 2 section mark parallel lines: 5.7 months with RASONQUE (N=248) and 2.6 months with SOC combination chemotherapy (N=252) HR=0.60 (95% CI: 0.46, 0.79).
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These results should be interpreted with caution due to the open-label design of the study. In addition, time-to-event PRO endpoints can be challenging to interpret due to factors such as defining deterioration, accounting for intercurrent events, and potential missing data.
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TTD in global health status (from EORTC QLQ-C30) and in pain (from EORTC QLQ-PAN26) were powered prespecified endpoints.2 Note that other domains of the 2 tools were not powered endpoints.
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*PROs questionnaires (EORTC QLQ-C30 and EORTC QLQ-PAN26) were completed in person on Day 1 of each cycle and at the end of treatment.16

†The EORTC QLQ-PAN26 assesses symptoms related to pancreatic cancer, including pain, dietary changes, jaundice, altered bowel habit, emotional problems related to pancreatic cancer, and other symptoms (cachexia, indigestion, flatulence, dry mouth, taste changes).16,17

‡TTD in clinically relevant symptom of pain is defined as the time from randomization to the first occurrence of an increase of ≥10 points from baseline in corresponding pain scale or death, whichever occurs first, in the EORTC QLQ-PAN26 pain scale.2

§The EORTC QLQ-C30 incorporates 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), a global health status–QoL scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, insomnia, constipation, and diarrhea), and perceived financial impact of the disease.16,17

||TTD in global health status–QoL is defined as the time from randomization to the first occurrence of clinically relevant deterioration of global QoL score as defined by a decrease of ≥10 points from baseline, or death, whichever occurs first, in EORTC QLQ-C30.2

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Trial design
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Safety
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5-FU=5-fluorouracil; BICR=blinded independent central review; CI=confidence interval; ECOG PS=Eastern Cooperative Oncology Group performance status; EORTC QLQ-C30=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EORTC QLQ-PAN26=European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer Module; FOLFOX=leucovorin + 5-FU + oxaliplatin; HR=hazard ratio; ITT=intent-to-treat; mFOLFIRINOX=modified leucovorin + 5-FU + irinotecan + oxaliplatin; mOS=median overall survival; mPFS=median progression-free survival; NE=not estimable; PFS=progression-free survival; PRO=patient-reported outcome; QoL=quality of life; RAS=rat sarcoma; SOC=standard of care.
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References: 1. RASONQUE. DRAFT 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. Wainberg ZA, Melisi D, Macarulla T, et al. NALIRIFOX versus nab-paclitaxel and gemcitabine in treatment-naive patients with metastatic pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised, open-label, phase 3 trial. Lancet. 2023;402(10409):1272-1281. doi:10.1016/S0140-6736(23)01366-1 4. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703. doi:10.1056/NEJMoa1304369 5. Conroy T, Desseigne F, Ychou M, et al; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-1825. doi:10.1056/NEJMoa1011923 6. Philip PA, Sahai V, Bahary N, et al. Devimistat (CPI-613) with modified fluorouarcil, oxaliplatin, irinotecan, and leucovorin (FFX) versus FFX for patients with metastatic adenocarcinoma of the pancreas: the phase III AVENGER 500 study. J Clin Oncol. 2024;42(31):3692-3701. doi:10.1200/JCO.23.02659 7. Tempero M, Oh D-Y, Tabernero J, et al. Ibrutinib in combination with nab-paclitaxel and gemcitabine for first-line treatment of patients with metastatic pancreatic adenocarcinoma: phase III RESOLVE study. Ann Oncol. 2021;32(5):600-608. doi:10.1016/j.annonc.2021.01.070 8. Bekaii-Saab T, Okusaka T, Goldstein D, et al. Napabucasin plus nab-paclitaxel with gemcitabine versus nab-paclitaxel with gemcitabine in previously untreated metastatic pancreatic adenocarcinoma: an adaptive multicentre, randomised, open-label, phase 3, superiority trial. EClinicalMedicine. 2023;58:101897. doi:10.1016/j.eclinm.2023.101897 9. Van Cutsem E, Tempero MA, Sigal D, et al; HALO 109-301 Investigators. Randomized phase III trial of pegvorhyaluronidase alfa with nab-paclitaxel plus gemcitabine for patients with hyaluronan-high metastatic pancreatic adenocarcinoma. J Clin Oncol. 2020;38(27):3185-3196. doi:10.1200/JCO.20.00590 10. Hecht JR, Lonardi S, Bendell J, et al. Randomized phase III study of FOLFOX alone or with pegilodecakin as second-line therapy in patients with metastatic pancreatic cancer that progressed after gemcitabine (SEQUOIA). J Clin Oncol. 2021;39(10):1108-1118. doi:10.1200/JCO.20.02232 11. Wang-Gillam A, Li C-P, Bodoky G, et al; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016;387(10018):545-557. doi:10.1016/S0140-6736(15)00986-1 12. De La Fouchardière C, Malka D, Cropet C, et al. Gemcitabine and paclitaxel versus gemcitabine alone after 5-fluorouracil, oxaliplatin, and irinotecan in metastatic pancreatic adenocarcinoma: a randomized phase III PRODIGE 65-UCGI 36-GEMPAX UNICANCER study. J Clin Oncol. 2024;42(9):1055-1066. doi:10.1200/JCO.23.00795 13. Hammel P, Metges J-P, Mercade TM, et al. TRYBECA-1: a randomized phase III study of eryaspase combined with chemotherapy versus chemotherapy as second-line treatment in patients with advanced pancreatic adenocarcinoma. J Clin Oncol. 2025;43(35):3714-3727. doi:10.1200/JCO-25-00872 14. Supplement to: 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 15. Villaruz LC, Socinski MA. The clinical viewpoint: definitions, limitations of RECIST, practical considerations of measurement. Clin Cancer Res. 2013;19(10):2629-2636. doi:10.1158/1078-0432.CCR-12-2935 16. Protocol for: 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 17. Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organisation for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85:365-376.
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