Erasca Announces Two Clinical Trial Collaboration and Supply Agreements for Trametinib to Evaluate Naporafenib Combination in SEACRAFT-1 and SEACRAFT-2 Trials
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Insights
The collaboration between Erasca and Novartis to evaluate naporafenib in combination with trametinib represents a significant step forward in the treatment of RAS Q61X solid tumors and NRAS-mutant melanoma. Given that these cancers are driven by specific genetic mutations, the use of targeted therapies could potentially offer a more effective treatment alternative compared to traditional chemotherapy, which is less precise and often associated with significant side effects.
Furthermore, the mutation-specific approach aligns with the current trend in oncology to personalize cancer treatment. The fact that the Phase 3 SEACRAFT-2 trial in NRAS-mutant melanoma is described as 'pivotal' indicates that the results could be decisive for the future of naporafenib as a treatment option. If successful, this could lead to a new standard of care for a subset of melanoma patients who currently have limited treatment options.
It is noteworthy that the adverse event profile of the drug combination has been characterized as 'tolerable and manageable,' which is crucial for patient quality of life and may influence treatment adherence and outcomes. The potential impact of these trials, if positive, could be profound, not only in clinical practice but also in terms of patient survival and quality of life.
The initiation of these clinical trials is a strategic move for Erasca, particularly given the high unmet need in the targeted patient populations. In the context of drug development, the term 'first-in-class' indicates that naporafenib represents a new and unique mechanism of action within its therapeutic area. This suggests that if the trials are successful, Erasca could capture a significant market share, especially since there are currently no approved targeted therapies for these specific RAS Q61X solid tumors and NRAS-mutant melanoma.
The collaboration with Novartis also provides a strategic advantage, as trametinib (MEKINIST®) is an established MEK inhibitor with proven efficacy in certain cancer types. Combining it with naporafenib could enhance the therapeutic efficacy and potentially lead to a combination therapy that offers a competitive edge in the oncology market.
From a research perspective, the outcome of these trials will contribute valuable data to the scientific community regarding the efficacy of pan-RAF inhibitors in combination with MEK inhibitors. This could pave the way for further research into similar combination therapies for other types of cancers driven by the RAS/MAPK pathway.
The potential market for naporafenib, if approved, is substantial, considering the annual incidence of RAS Q61X solid tumors and NRAS-mutant melanoma in the United States and Europe. The absence of approved targeted therapies for these mutations underscores the opportunity for Erasca to meet a critical need in the oncology market. An approval could lead to significant revenue generation for the company.
Investors will likely monitor the progress of the SEACRAFT trials closely, as the results could have a considerable impact on Erasca's stock valuation. Positive data could lead to investor optimism and an increase in stock price, while negative results could have the opposite effect. The timing of the data release between Q2-Q4 2024 will also be a key period for market analysts to assess the potential impact on Erasca's financial outlook.
Lastly, the fact that Novartis is supplying trametinib at no cost for the trials could improve the cost-efficiency of the research and development process for Erasca, potentially enhancing the company's financial sustainability and attractiveness to investors.
Naporafenib is a potential first-in-class and best-in-class pan-RAF inhibitor in multiple RAS/MAPK pathway-driven tumors
Initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors expected between Q2-Q4 2024
Initiation of pivotal SEACRAFT-2 in NRASm melanoma expected in H1 2024
SAN DIEGO, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced two clinical trial collaboration and supply agreements (CTCSAs) with Novartis (NYSE: NVS) for the MEK inhibitor trametinib (MEKINIST®).
The agreements will support the clinical development of the pan-RAF inhibitor naporafenib in combination with trametinib for the treatment of patients with RAS Q61X solid tumors in the Phase 1b SEACRAFT-1 trial and in patients with previously treated NRAS-mutant (NRASm) unresectable or metastatic melanoma in the randomized, pivotal Phase 3 SEACRAFT-2 trial. Erasca is sponsoring the trials, and Novartis is supplying trametinib at no cost.
“We are excited to work with Novartis to further evaluate the promising clinical development of naporafenib in combination with trametinib in our SEACRAFT trials as part of our two lead indications: NRASm melanoma and RAS Q61X solid tumors,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “Both trials are supported by compelling anti-tumor activity with a tolerable and manageable adverse event profile demonstrated in clinical data generated by Novartis. We expect to initiate our SEACRAFT-2 Phase 3 trial in the first half of 2024 and report initial SEACRAFT-1 Phase 1b combination data in RAS Q61X solid tumors between the second and fourth quarters of 2024.”
In the United States and Europe, approximately 150,000 patients with RAS Q61X solid tumors are diagnosed annually, particularly in melanoma, non-small cell lung cancer (NSCLC), thyroid cancer, colorectal cancer, pancreatic cancer, and other tumor types. Approximately 20
About Naporafenib
Naporafenib (formerly LXH254) is a potent and selective pan-RAF inhibitor, with a potential first-in-class and best-in-class profile. Naporafenib has been dosed in over 500 patients to date, whereby safety, tolerability, pharmacokinetics, and pharmacodynamics have been established in both monotherapy and select combinations. Clinical proof-of-concept (PoC) has been established for the combination with trametinib for patients with NRAS-mutant (NRASm) melanoma, which includes NRAS Q61X melanoma, and preliminary clinical PoC has been established for the combination with trametinib for patients with RAS Q61X in non-small cell lung cancer (NSCLC). Erasca plans to focus initially on advancing and securing regulatory approval for naporafenib plus trametinib in NRASm melanoma as part of the planned pivotal Phase 3 SEACRAFT-2 trial and in RAS Q61X tissue agnostic solid tumors as part of the Phase 1b SEACRAFT-1 trial, respectively. Erasca is also exploring additional combinations of naporafenib with other proprietary therapeutic agents in our pipeline. Naporafenib has received FDA Fast Track Designation for patients with unresectable or metastatic NRASm melanoma who have progressed on, or are intolerant to, an anti-PD(L)-1 based regimen.
About Erasca
At Erasca, our name is our mission: To erase cancer. We are a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers. Our company was co-founded by leading pioneers in precision oncology and RAS targeting to create novel therapies and combination regimens designed to comprehensively shut down the RAS/MAPK pathway for the treatment of cancer. We have assembled one of the deepest RAS/MAPK pathway-focused pipelines in the industry. We believe our team’s capabilities and experience, further guided by our scientific advisory board which includes the world’s leading experts in the RAS/MAPK pathway, uniquely position us to achieve our bold mission of erasing cancer.
Cautionary Note Regarding Forward-Looking Statements
Erasca cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: our expectations regarding the potential therapeutic benefits of our product candidates and the potential patient populations for our product candidates, including naporafenib; the planned advancement of our development pipeline, including the development plan and anticipated timing of the data readout and dosing of the first patient in the SEACRAFT-1 and SEACRAFT-2 clinical trials, respectively; and our ability to realize the benefits of the CTCSA described in this press release. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our approach to the discovery and development of product candidates based on our singular focus on shutting down the RAS/MAPK pathway, a novel and unproven approach; potential delays in the commencement, enrollment, data readouts, and completion of clinical trials and our preclinical studies; our dependence on third parties in connection with manufacturing, the supply of third-party drugs, research, and preclinical and clinical testing; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval, and/or commercialization, or may result in recalls or product liability claims; unfavorable results from preclinical studies or clinical trials; results from preclinical studies or early clinical trials not necessarily being predictive of future results; preliminary results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data and as more patient data become available; we have not completed any clinical trials of naporafenib and are reliant on data generated by Novartis in prior clinical trials conducted by it; our planned SEACRAFT trials may not support the registration of naporafenib; our assumptions regarding which programs may have a higher probability of success may not be accurate, and we may expend our limited resources to pursue a particular product candidate and/or indication and fail to capitalize on product candidates or indications with greater development or commercial potential; regulatory developments in the United States and foreign countries; a FDA Fast Track Designation (FTD) may not result in a more expedited development or regulatory review process, and such a designation does not increase the likelihood that naporafenib in combination with trametinib will receive marketing approval in the United States; the FDA may later decide that naporafenib in combination with trametinib no longer meets the conditions for FTD; our dependence on third parties in connection with our existing collaboration and supply agreements (including the CTCSA described in this press release); our ability to obtain and maintain intellectual property protection for our product candidates and maintain our rights under intellectual property licenses; the impact of global geopolitical events and war on our business; our ability to fund our operating plans with our current cash, cash equivalents, and marketable securities; and other risks described in our prior filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent annual report on Form 10-K for the year ended December 31, 2022, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
MEKINIST® is a registered trademark owned by or licensed to Novartis, its subsidiaries, or affiliates.
Contact:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
Source: Erasca, Inc.
FAQ
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