Revolution Medicines Announces First Patient Dosed in Phase 3 Study Evaluating RMC-6236 in Previously Treated Patients with Metastatic Pancreatic Ductal Adenocarcinoma
Revolution Medicines has announced the dosing of the first patient in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The global, randomized, open-label study will evaluate RMC-6236 monotherapy against standard chemotherapy in approximately 460 patients worldwide who have received one prior line of therapy.
The study focuses on patients with PDAC harboring specific RAS mutations. Primary endpoints are progression-free survival (PFS) and overall survival (OS) in the core patient population. This milestone marks a significant step in Revolution Medicines' mission to revolutionize treatment for RAS-addicted cancers, particularly PDAC, which has a five-year survival rate of only 3% in metastatic cases.
Revolution Medicines ha annunciato la somministrazione della prima dose al paziente nello studio RASolute 302, uno studio registrativo di Fase 3 per RMC-6236, un inibitore multi-selettivo RAS(ON), per adenocarcinoma pancreatico duttale metastatico (PDAC) precedentemente trattato. Lo studio globale, randomizzato e in aperto valuterà la monoterapia con RMC-6236 rispetto alla chemioterapia standard in circa 460 pazienti in tutto il mondo che hanno ricevuto una linea di terapia precedente.
Lo studio si concentra su pazienti con PDAC portatori di specifiche mutazioni RAS. Gli endpoint primari sono la sopravvivenza libera da progressione (PFS) e la sopravvivenza generale (OS) nella popolazione centrale di pazienti. Questo traguardo segna un passo significativo nella missione di Revolution Medicines di rivoluzionare il trattamento per i tumori dipendenti da RAS, in particolare il PDAC, che ha un tasso di sopravvivenza a cinque anni di solo il 3% nei casi metastatici.
Revolution Medicines ha anunciado la dosificación del primer paciente en el estudio RASolute 302, un estudio registracional de Fase 3 de RMC-6236, un inhibidor multi-selectivo RAS(ON), para adenocarcinoma ductal pancreático metastásico (PDAC) previamente tratado. El estudio global, aleatorizado y abierto evaluará la monoterapia con RMC-6236 frente a la quimioterapia estándar en aproximadamente 460 pacientes en todo el mundo que han recibido una línea de tratamiento previa.
El estudio se centra en pacientes con PDAC que presentan mutaciones específicas de RAS. Los objetivos primarios son la supervivencia libre de progresión (PFS) y la supervivencia global (OS) en la población central de pacientes. Este hito marca un paso significativo en la misión de Revolution Medicines de revolucionar el tratamiento de los cánceres adictos a RAS, en particular el PDAC, que tiene una tasa de supervivencia a cinco años de solo el 3% en casos metastásicos.
Revolution Medicines는 RASolute 302의 첫 번째 환자 투여를 발표했습니다. 이는 RMC-6236이라는 RAS(ON) 다중 선택 억제제에 대한 3상 등록 연구로, 이전 치료를 받은 전이성 췌장관 선암(PDAC)을 대상으로 합니다. 이 글로벌, 무작위, 개방형 연구는 한 차례 치료를 받은 전 세계 약 460명 환자
연구는 특정 RAS 변이를 가진 PDAC 환자에게 중점을 두고 있습니다. 주요 목표는 핵심 환자 집단에서 무진행 생존 기간(PFS) 및 전체 생존 기간(OS)입니다. 이 이정표는 RAS 의존 암, 특히 전이성 PDAC에 대한 치료를 혁신하려는 Revolution Medicines의 사명에서 중요한 단계입니다. PDAC은 전이성 사례에서 5년 생존율이 3%에 불과합니다.
Revolution Medicines a annoncé l'administration de la première dose au patient dans l'étude RASolute 302, une étude d'enregistrement de Phase 3 sur RMC-6236, un inhibiteur RAS(ON) multi-sélectif, pour l'adénocarcinome ductal pancréatique (PDAC) précédemment traité. L'étude mondiale, randomisée et ouverte évaluera la monothérapie par RMC-6236 par rapport à la chimiothérapie standard chez environ 460 patients dans le monde qui ont reçu une ligne de traitement antérieure.
L'étude se concentre sur les patients atteints de PDAC présentant des mutations spécifiques du RAS. Les critères principaux sont la survie sans progression (PFS) et la survie globale (OS) dans la population de patients principale. Cette étape marque une avancée significative dans la mission de Revolution Medicines de révolutionner le traitement des cancers dépendants du RAS, en particulier le PDAC, qui a un taux de survie à cinq ans de seulement 3 % dans les cas métastatiques.
Revolution Medicines hat die Dosierung des ersten Patienten in RASolute 302 bekannt gegeben, einer registrierungsrelevanten Phase-3-Studie zu RMC-6236, einem RAS(ON) multi-selektiven Inhibitor für bereits behandeltes metastasiertes duktales Pankreaskarzinom (PDAC). Die globale, randomisierte, offene Studie wird die Monotherapie mit RMC-6236 gegen die Standardchemotherapie bei etwa 460 Patienten weltweit, die eine vorherige Therapie erhalten haben, bewerten.
Die Studie konzentriert sich auf Patienten mit PDAC, die spezifische RAS-Mutationen aufweisen. Die primären Endpunkte sind progressionsfreie Überlebenszeit (PFS) und Gesamtüberleben (OS) in der Kernpatientenpopulation. Dieser Meilenstein markiert einen bedeutenden Schritt in der Mission von Revolution Medicines, die Behandlung von RAS-abhängigen Krebserkrankungen, insbesondere von PDAC, das eine fünfjährige Überlebensrate von nur 3% bei metastatischen Fällen aufweist, zu revolutionieren.
- Initiation of Phase 3 registrational study for RMC-6236 in metastatic PDAC
- Potential to address a significant unmet medical need in pancreatic cancer treatment
- RMC-6236 designed to directly inhibit RAS(ON) signaling, the primary oncogenic driver of pancreatic cancer
- Encouraging initial PFS and OS observations from Phase 1 trial support the Phase 3 study
- High mortality rate and late-stage diagnosis associated with pancreatic cancer
- Challenging market with existing treatments showing efficacy
- Potential competition from other targeted therapies in development
Insights
The initiation of the Phase 3 RASolute 302 study for RMC-6236 in metastatic pancreatic ductal adenocarcinoma (PDAC) is a significant milestone for Revolution Medicines. This trial targets a critical unmet need in oncology, as PDAC remains one of the most lethal and difficult-to-treat cancers.
Key points to consider:
- The study design is robust, with dual primary endpoints of progression-free survival (PFS) and overall survival (OS) in a core population of RAS G12X mutated PDAC patients.
- The expanded population includes additional RAS mutations, potentially broadening the drug's applicability.
- With
90% of PDAC cases harboring RAS mutations, RMC-6236's mechanism of directly inhibiting RAS(ON) signaling could be groundbreaking if successful. - The Phase 1 data suggesting encouraging PFS and OS observations provides a solid foundation for this larger study.
However, investors should note that Phase 3 trials are lengthy and costly, with no guarantee of success. The outcome of this study could significantly impact RVMD's valuation and future prospects in the competitive oncology market.
This Phase 3 trial initiation represents a important inflection point for Revolution Medicines, potentially accelerating its path to market. Key financial implications include:
- Increased R&D expenses are likely as the company conducts this large, global study with approximately 460 patients.
- The addressable market is substantial, with an estimated 60,000 new pancreatic cancer cases in the U.S. alone in 2024.
- If successful, RMC-6236 could capture a significant share of the pancreatic cancer treatment market, currently valued at over
$2 billion globally. - Positive trial results could lead to partnership opportunities or increased investor interest, potentially boosting the company's
$8.4 billion market cap.
However, investors should be cautious. The company will likely need to secure additional funding to support this and other ongoing trials. The long timeline to potential approval (likely 2-3 years minimum) means near-term revenue impact is The stock may experience volatility based on interim data readouts and competitor developments in the RAS inhibitor space.
REDWOOD CITY, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the first patient has been dosed in RASolute 302, a Phase 3 registrational study of RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma (PDAC).
![RASolute[71]](https://ml.globenewswire.com/Resource/Download/acdbaed2-d2de-4f6a-a00c-141b3d49a029/rasolute-71-.jpg)
RASolute 302 is a global, randomized, open-label Phase 3 study designed to evaluate the safety and efficacy of RMC-6236 monotherapy for patients with metastatic pancreatic cancer compared with standard of care chemotherapy. The trial is anticipated to enroll approximately 460 patients worldwide who had received one prior line of therapy with a 5-fluorouracil (5-FU)-based or gemcitabine-based regimen. The study design focuses on a core population of patients with PDAC harboring RAS mutations at position 12 (RAS G12X) and an expanded population that includes patients with tumors harboring RAS mutations at position G12 (RAS G12X), G13 (RAS G13X) or Q61 (RAS Q61X), or those without any identified targetable mutation. The dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS and OS in the expanded population of patients. Additional information about RASolute 302 (NCT06625320) is available at clinicaltrials.gov.
“Treating the first patient in RASolute 302 is a significant milestone for Revolution Medicines as we seek to revolutionize treatment for patients with RAS-addicted cancers,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “RMC-6236 is designed to directly inhibit RAS(ON) signaling, which is the primary oncogenic driver of pancreatic cancer. Supported by the encouraging initial PFS and OS observations and safety profile reported from the Phase 1 RMC-6236 monotherapy trial, the randomized RASolute 302 trial will formally assess the potential for this bold investigational drug to make a meaningful difference for people living with metastatic PDAC, one of the most difficult-to-treat cancers.”
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 in 2024, approximately 60,000 people will be diagnosed with pancreatic cancer, 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 RMC-6236
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. RMC-6236 suppresses RAS signaling by blocking the interaction of RAS(ON) with its downstream effectors. It does so across oncogenic RAS mutations G12X, G13X and Q61X, in 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 clinical-stage oncology company developing novel targeted therapies for RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors RMC-6236, a RAS(ON) multi-selective inhibitor, RMC-6291, a RAS(ON) G12C-selective inhibitor, and RMC-9805, a RAS(ON) G12D-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-5127 (G12V), RMC-0708 (Q61H) and RMC-8839 (G13C), in addition to RAS companion inhibitors RMC-4630 and RMC-5552.
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 and findings from these studies, including the safety, tolerability, potential efficacy and durability of the company’s candidates being studied; dosing and enrollment in the company’s clinical trials; and the company’s goals to impact treatment of RAS-addicted cancers. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "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’s 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’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s 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’s 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’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 7, 2024, 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.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/acdbaed2-d2de-4f6a-a00c-141b3d49a029
FAQ
What is the purpose of Revolution Medicines' RASolute 302 Phase 3 study for RMC-6236?
How many patients are expected to be enrolled in the RASolute 302 study for RVMD's RMC-6236?
What are the primary endpoints of Revolution Medicines' Phase 3 RASolute 302 study?
What type of cancer is Revolution Medicines targeting with RMC-6236 in the Phase 3 trial?
What is the mechanism of action for RVMD's RMC-6236 in treating pancreatic cancer?
