Revolution Medicines Shares New Clinical Results Supporting Initiation of RASolute 303, a Global Phase 3 Registrational Trial of Daraxonrasib in First Line Metastatic Pancreatic Ductal Adenocarcinoma
Revolution Medicines (NASDAQ:RVMD) announced promising clinical results for daraxonrasib in treating pancreatic ductal adenocarcinoma (PDAC). The data supports the initiation of RASolute 303, a global Phase 3 registrational trial in Q4 2025.
Key findings include:
- In second-line treatment, daraxonrasib showed 35% objective response rate and 13.1 months median overall survival for RAS G12X mutation patients
- First-line monotherapy demonstrated 47% objective response rate with 89% disease control rate
- Combination therapy with GnP achieved 55% objective response rate with 90% disease control rate
The upcoming Phase 3 trial will evaluate daraxonrasib both as monotherapy and in combination with GnP chemotherapy for first-line metastatic PDAC treatment.
Revolution Medicines (NASDAQ:RVMD) ha annunciato risultati clinici promettenti per daraxonrasib nel trattamento dell'adenocarcinoma duttale del pancreas (PDAC). I dati supportano l'avvio di RASolute 303, uno studio registrativo globale di Fase 3, nel quarto trimestre 2025.
Risultati chiave includono:
- Nel trattamento di seconda linea, daraxonrasib ha mostrato un tasso di risposta obiettiva del 35% e una sopravvivenza mediana globale di 13,1 mesi nei pazienti con mutazione RAS G12X
- In prima linea, come monoterapia, ha dimostrato un tasso di risposta obiettiva del 47% con un tasso di controllo della malattia dell'89%
- La terapia in combinazione con GnP ha raggiunto un tasso di risposta obiettiva del 55% con un tasso di controllo della malattia del 90%
Il prossimo trial di Fase 3 valuter脿 daraxonrasib sia come monoterapia sia in combinazione con la chemioterapia GnP per il trattamento di prima linea del PDAC metastatico.
Revolution Medicines (NASDAQ:RVMD) anunci贸 resultados cl铆nicos prometedores para daraxonrasib en el tratamiento del adenocarcinoma ductal pancre谩tico (PDAC). Los datos respaldan el inicio de RASolute 303, un ensayo registracional global de Fase 3, en el cuarto trimestre de 2025.
Hallazgos clave incluyen:
- En segunda l铆nea, daraxonrasib mostr贸 una tasa de respuesta objetiva del 35% y una supervivencia global mediana de 13,1 meses en pacientes con la mutaci贸n RAS G12X
- En primera l铆nea como monoterapia demostr贸 una tasa de respuesta objetiva del 47% con una tasa de control de la enfermedad del 89%
- La terapia combinada con GnP logr贸 una tasa de respuesta objetiva del 55% con una tasa de control de la enfermedad del 90%
El pr贸ximo ensayo de Fase 3 evaluar谩 daraxonrasib tanto en monoterapia como en combinaci贸n con la quimioterapia GnP para el tratamiento de primera l铆nea del PDAC metast谩sico.
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欤检殧 瓴瓣臣電� 雼れ潓瓿� 臧欖姷雼堧嫟:
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- 1彀� 雼弲鞖旊矔鞐愳劀電� 臧濌磤鞝� 氚橃潙毳� 47%瓿� 89%鞚� 歆堧硲 臁办爤毳犾潉 氤挫榾鞀惦媹雼�
- GnP鞕�鞚� 氤戩毄鞖旊矔鞚� 臧濌磤鞝� 氚橃潙毳� 55%鞕� 90%鞚� 歆堧硲 臁办爤毳犾潉 雼劚頄堨姷雼堧嫟
雼り皜鞓る姅 3靸� 鞁滍棙鞚� 鞝勳澊靹� PDAC鞚� 1彀� 旃橂搿滌劀 daraxonrasib毳� 雼弲鞖旊矔 氚� GnP 頇旐暀鞖旊矔瓿检潣 氤戩毄鞖旊矔 氇憪鞐愳劀 韽夑皜頃� 鞓堨爼鞛呺媹雼�.
Revolution Medicines (NASDAQ:RVMD) a annonc茅 des r茅sultats cliniques prometteurs pour le daraxonrasib dans le traitement de l'ad茅nocarcinome canalaire du pancr茅as (PDAC). Les donn茅es soutiennent le lancement de RASolute 303, un essai d'enregistrement mondial de Phase 3, au quatri猫me trimestre 2025.
Principaux r茅sultats聽:
- En traitement de deuxi猫me ligne, daraxonrasib a montr茅 un taux de r茅ponse objective de 35% et une survie globale m茅diane de 13,1 mois chez les patients porteurs de la mutation RAS G12X
- En premi猫re ligne en monoth茅rapie, il a d茅montr茅 un taux de r茅ponse objective de 47% avec un taux de contr么le de la maladie de 89%
- La th茅rapie combin茅e avec GnP a atteint un taux de r茅ponse objective de 55% avec un taux de contr么le de la maladie de 90%
Le prochain essai de Phase 3 茅valuera le daraxonrasib 脿 la fois en monoth茅rapie et en association avec la chimioth茅rapie GnP pour le traitement de premi猫re ligne du PDAC m茅tastatique.
Revolution Medicines (NASDAQ:RVMD) gab vielversprechende klinische Ergebnisse f眉r daraxonrasib bei der Behandlung des duktalen Pankreasadenokarzinoms (PDAC) bekannt. Die Daten unterst眉tzen den Start von RASolute 303, einer globalen Phase鈥�3鈥慠egistrierungsstudie, im vierten Quartal 2025.
Wesentliche Ergebnisse umfassen:
- In der Zweitlinientherapie zeigte daraxonrasib eine objektive Ansprechrate von 35% und ein medianes Gesamt眉berleben von 13,1 Monaten bei Patienten mit RAS G12X鈥慚utation
- Als Erstlinien鈥慚onotherapie erzielte es eine objektive Ansprechrate von 47% mit einer Krankheitskontrollrate von 89%
- Die Kombinationstherapie mit GnP erreichte eine objektive Ansprechrate von 55% mit einer Krankheitskontrollrate von 90%
Die bevorstehende Phase鈥�3鈥慡tudie wird daraxonrasib sowohl als Monotherapie als auch in Kombination mit der GnP鈥慍hemotherapie f眉r die Erstlinientherapie des metastasierten PDAC bewerten.
- None.
- Additional follow-up needed to determine durability of clinical benefit in first-line treatment
- Mean dose intensity reduced to 81-85% across treatment groups
Insights
Revolution Medicines reports positive clinical results for daraxonrasib in pancreatic cancer, supporting advancement to pivotal Phase 3 trials.
The clinical data released by Revolution Medicines for daraxonrasib in pancreatic ductal adenocarcinoma (PDAC) represents a significant development in a cancer type with historically limited treatment options. The most compelling findings come from the second-line metastatic PDAC setting, where daraxonrasib monotherapy demonstrated a 29% confirmed objective response rate and impressive 8.1-month median progression-free survival in patients with any RAS mutation. The 15.6-month median overall survival is particularly noteworthy for this aggressive cancer type.
The first-line metastatic PDAC data further strengthens daraxonrasib's clinical profile. As monotherapy, it achieved a 47% objective response rate and 89% disease control rate. When combined with gemcitabine/nab-paclitaxel chemotherapy, response rates increased to 55%, suggesting additive or synergistic effects. The safety profile appears manageable with mean dose intensities of 85% for monotherapy and 81% for the combination.
Daraxonrasib's mechanism targeting RAS mutations broadly is particularly relevant for pancreatic cancer, where KRAS mutations are nearly ubiquitous (~90% of cases). The planned three-arm Phase 3 trial (RASolute 303) will be crucial in determining if daraxonrasib can establish a new standard of care. The current standard first-line treatments for metastatic PDAC (FOLFIRINOX or gemcitabine/nab-paclitaxel) typically yield response rates of 23-31% and median overall survival of 8.5-11.1 months, suggesting daraxonrasib could potentially improve outcomes in this difficult-to-treat population.
With the ongoing Phase 3 second-line trial (RASolute 302) fully enrolled and the first-line Phase 3 trial (RASolute 303) starting in Q4 2025, Revolution Medicines is strategically positioned to potentially transform the treatment landscape for pancreatic cancer in the coming years.
Long-term follow-up data for daraxonrasib monotherapy in second line metastatic pancreatic ductal adenocarcinoma reinforces promising clinical activity and durability
Highly encouraging initial clinical results for daraxonrasib monotherapy and daraxonrasib plus chemotherapy in first line metastatic pancreatic ductal adenocarcinoma support planned initiation of three-arm Phase 3 trial in Q4 2025
Revolution Medicines to host webcast today at 5:00 p.m. Eastern Time
REDWOOD CITY, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced key clinical updates from its daraxonrasib Phase 1 clinical trials. The data, to be presented during an investor webcast today at 5:00 p.m. Eastern Time (ET), will focus on new daraxonrasib data in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), including long-term follow-up data in second line patients and initial monotherapy and chemotherapy-combination data in first line patients.
鈥淧atients living with pancreatic cancer have an urgent need for more effective and durable treatment options, and we are pursuing a bold vision to establish new global standards of care across treatment lines for this devastating disease,鈥� said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. 鈥淒araxonrasib鈥檚 pioneering mechanism of action covering RAS cancer driver mutations broadly, and highly encouraging new clinical findings released today, together provide strong evidence of its potential to serve these patients. The promising clinical profile observed in investigational studies to date in both previously treated and treatment-na茂ve patients with pancreatic cancer compels initiation of our planned registrational study evaluating daraxonrasib as monotherapy and in combination with chemotherapy in the first line metastatic setting.鈥�
Daraxonrasib Monotherapy: Long-term Follow-Up in 2L Metastatic PDAC
As of a June 30, 2025 cutoff date, patients with second line and beyond (2L+) metastatic PDAC treated with daraxonrasib 300 mg daily (QD) were evaluated for long-term follow-up on key safety and efficacy endpoints.
- Safety: In 2L+ patients with RAS mutant PDAC (n=83), daraxonrasib 300 mg QD was generally well tolerated with a safety profile consistent with . No new safety signals were identified.
- Efficacy: Daraxonrasib at 300 mg QD demonstrated compelling antitumor activity and durability, with the following results for patients with second line (2L) RAS mutant PDAC with a RAS G12X mutation (n=26) or any RAS mutation (n=38), respectively:
- The confirmed objective response rate (ORR) per RECIST v1.1 was
35% and29% . - The disease control rate (DCR) was
92% and95% . - The median progression-free survival (PFS) was 8.5 months (
95% confidence interval (CI), 6.7 鈥� 10.5) and 8.1 months (95% CI, 5.9 鈥� 10.1). - The median overall survival (OS) was 13.1 (
95% CI, 10.9 鈥� NE) and 15.6 months (95% CI, 10.9 鈥� NE). - Median follow-up was 16.7 months.
- The confirmed objective response rate (ORR) per RECIST v1.1 was
- RASolute 302, the ongoing Phase 3 registrational trial of daraxonrasib monotherapy as a 2L treatment for metastatic PDAC, remains on track to complete global enrollment this year to enable an expected data readout in 2026.
Daraxonrasib Monotherapy: Initial Results in 1L Metastatic PDAC
As of a July 28, 2025 cutoff date, patients with treatment-na茂ve RAS-mutant PDAC treated with daraxonrasib 300 mg QD monotherapy were evaluated on key safety and antitumor activity endpoints.
- Safety: In patients treated in this cohort (n=40), the safety profile observed for daraxonrasib monotherapy as a first line (1L) treatment was generally consistent with the reported safety findings for daraxonrasib in the 2L setting. The mean dose intensity was
85% . - Efficacy: In patients who met the definition of 1L metastatic PDAC and had sufficient follow-up (n=38), the ORR was
47% and the DCR was89% , with a median follow-up of 9.3 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
Daraxonrasib plus Gemcitabine nab-Paclitaxel (GnP) Combination: Initial Results in 1L Metastatic PDAC
The combination of daraxonrasib plus chemotherapy is designed to sustain continuous suppression of RAS signaling by maintaining sufficient dose intensity for daraxonrasib, to leverage the antitumor contribution of chemotherapy and to achieve a safety profile that is competitive against standard chemotherapy.
For the combination, the company selected daraxonrasib 200 mg QD plus the standard dose of GnP given on a Days 1 and 15 schedule.
As of a July 28, 2025 data cutoff date, patients with 1L metastatic PDAC treated with the combination of daraxonrasib plus GnP were evaluated on key safety and antitumor activity endpoints.
- Safety: In patients with RAS mutations (n=40), daraxonrasib plus GnP was generally well tolerated. The safety profile observed for the combination regimen was consistent with the sum of the known safety findings of each respective agent, and no new safety signals emerged. The mean dose intensity was
81% . - Efficacy: In patients who had sufficient follow-up (n=31), the ORR was
55% and the DCR was90% , with a median follow-up of 6.9 months. The majority of patients remained on study treatment as of the data cutoff date, and additional follow-up will be needed to determine the durability of clinical benefit.
These encouraging clinical results support the company鈥檚 plans to initiate RASolute 303, a global, randomized Phase 3 trial in patients with 1L metastatic PDAC, in the fourth quarter of 2025. The three-arm trial will evaluate daraxonrasib monotherapy and the combination of daraxonrasib plus GnP, each compared to a control arm with GnP treatment.
Investor Webcast
Revolution Medicines management will host an investor webcast today, September 10, at 5:00 p.m. ET (2:00 p.m. PT) to discuss these updates. To participate in the live webcast, participants may register at . A live webcast of the call will be available on the website at聽. Following the live webcast, a replay will be available on the company鈥檚 website for at least 14 days.
About Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma
Pancreatic cancer is one of the most lethal malignancies, characterized by its typically late-stage diagnosis, resistance to standard chemotherapy, and high mortality rate. In the U.S., recent estimates indicate that approximately 60,000 people will be diagnosed annually with pancreatic cancer1, and about 50,000 people will die from this aggressive disease.
The most common form of pancreatic cancer, pancreatic ductal adenocarcinoma (PDAC) and its variants, accounts for approximately
About Daraxonrasib
Daraxonrasib (RMC-6236) is an oral, direct RAS(ON) multi-selective inhibitor with the potential to help address a wide range of cancers driven by oncogenic RAS mutations. Daraxonrasib suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so by targeting oncogenic RAS mutations G12X, G13X and Q61X that are common drivers of major cancers, including pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).
About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company鈥檚 R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company鈥檚 RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; and zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor, are currently in clinical development. The company anticipates that RMC-5127, a RAS(ON) G12V-selective inhibitor, will be its next RAS(ON) inhibitor to enter clinical development. Additional development opportunities in the company鈥檚 pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit聽聽and follow us on聽.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding: progression of clinical studies, including the expected timing and plans for enrollment completion and data readouts; the potential for any of the company鈥檚 investigational products, including daraxonrasib, to become a new global standard of care for patients with pancreatic cancer and address their urgent need for more effective and durable treatment options; expected findings from the company鈥檚 clinical studies, including the safety, tolerability and antitumor activity of the company鈥檚 candidates being studied and the durability of these results; expected timing and design of the company鈥檚 planned clinical trials, including the company鈥檚 plans for RASolute 303; the company鈥檚 development plans including its expectation that RMC-5127 will be its next RAS(ON) inhibitor to enter clinical development; and the ability of the company to bring its clinical candidates to patients. Forward-looking statements are typically, but not always, identified by the use of words such as "will," "believe," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause the company鈥檚 development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including the company鈥檚 programs鈥� current stage of development, the process of designing and conducting preclinical and clinical trials, risks that the results of prior clinical trials may not be predictive of future clinical trials, clinical efficacy, or other future results, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company鈥檚 ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company鈥檚 capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape, and the effects on the company鈥檚 business of the global events, such as international conflicts or global pandemics. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines鈥� Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the 鈥淪EC鈥�) on August 6, 2025, and its future periodic reports to be filed with the SEC. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
Revolution Medicines Media & Investor Contact:
[email protected]
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1 Siegel RL, et al. CA Cancer J Clin. 2024;74:12-49.
2 Hallbrook CJ, et al. Cell. 2023;186:1729-1754.
3 Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1);91. Doi:10.1038/s41698-022-00334-z.
4 American Cancer Society. Survival Rates for Pancreatic Cancer. Available at: . Accessed June 2025.
FAQ
What are the key results of Revolution Medicines' daraxonrasib trial in pancreatic cancer?
When will Revolution Medicines (RVMD) start the Phase 3 RASolute 303 trial?
What is the survival rate for daraxonrasib in second-line PDAC treatment?
How effective is daraxonrasib combined with chemotherapy for pancreatic cancer?
What is the design of RVMD's upcoming Phase 3 RASolute 303 trial?
