Mural Oncology Provides Update on Phase 3 ARTISTRY-7 Trial of Nemvaleukin in Combination with KEYTRUDA® (pembrolizumab) in Patients with Platinum-Resistant Ovarian Cancer
Rhea-AI Summary
Mural Oncology (MURA) announced the discontinuation of its Phase 3 ARTISTRY-7 trial evaluating nemvaleukin alfa in combination with KEYTRUDA® for platinum-resistant ovarian cancer (PROC). The decision came after interim analysis showed no statistically significant improvement in overall survival compared to chemotherapy.
The combination therapy achieved a median overall survival of 10.1 months versus 9.8 months for chemotherapy (hazard ratio: 0.98). Despite the setback in PROC treatment, nemvaleukin maintained a favorable safety profile across its clinical program, which has treated over 800 patients.
The company will continue its Phase 2 ARTISTRY-6 trial in mucosal melanoma, with topline results expected in Q2 2025. Additional data readouts for less-frequent intravenous dosing in cutaneous melanoma patients are anticipated in Q2 2025 for monotherapy (cohort 3) and H2 2025 for combination therapy (cohort 4).
Positive
- Favorable safety profile maintained across 800+ patients
- Phase 2 ARTISTRY-6 trial in mucosal melanoma continues as planned
- Multiple data readouts expected throughout 2025
Negative
- Phase 3 ARTISTRY-7 trial failed to meet survival endpoints
- Development discontinued for platinum-resistant ovarian cancer
- No significant improvement over standard chemotherapy (10.1 vs 9.8 months survival)
Insights
The failure of the ARTISTRY-7 Phase 3 trial represents a significant setback for Mural Oncology's lead asset nemvaleukin in platinum-resistant ovarian cancer (PROC). The trial's interim analysis showed nemvaleukin plus pembrolizumab provided no survival advantage over chemotherapy (10.1 vs 9.8 months, hazard ratio: 0.98), leading to early termination and abandonment of this indication.
This outcome is particularly disappointing given the high unmet need in PROC, which remains an immunologically "cold" tumor resistant to immunotherapy approaches. The median survival of approximately 10 months in both arms underscores the challenging nature of this disease and why novel treatment approaches are desperately needed.
The company's pivot to focus on mucosal melanoma through the ARTISTRY-6 trial represents their best near-term opportunity, with topline data expected in Q2 2025. This rare melanoma subtype has historically poor response to standard immunotherapies, potentially offering a niche indication where nemvaleukin could demonstrate differentiated efficacy.
The safety profile remains a bright spot, with over 800 patients treated showing consistent and manageable tolerability. This favorable safety profile could prove valuable for potential approval in less common indications like mucosal melanoma, where the risk-benefit calculation differs from larger indications.
Mural Oncology's Phase 3 ARTISTRY-7 failure significantly narrows the commercial potential for nemvaleukin, the company's lead asset. The abandonment of the platinum-resistant ovarian cancer indication eliminates what would have been a substantial market opportunity with approximately 20,000 annual cases in the US alone.
For a clinical-stage company with $67.3M market cap, this trial failure substantially increases execution risk around the remaining pipeline. The company's value now hinges predominantly on the upcoming mucosal melanoma data from ARTISTRY-6, a much smaller potential market but one with clearer regulatory pathway as a rare cancer with treatment options.
Resource allocation will be critical going forward. Without the ovarian cancer indication, Mural must carefully manage its remaining capital to support the continued development of nemvaleukin in melanoma indications. The company hasn't disclosed burn rate details in this release, but investors should closely monitor cash position in upcoming quarterly reports.
The minimal difference in survival outcomes between the treatment and control arms (10.1 vs 9.8 months) suggests fundamental limitations in nemvaleukin's mechanism in certain tumor types. This raises questions about potential efficacy in other solid tumors with similar immunosuppressive microenvironments, though the distinct biology of melanoma provides scientific rationale for potentially better outcomes in that indication.
Based on overall survival data observed in interim analysis in platinum-resistant ovarian cancer, Mural will not progress trial to final analysis
Continued demonstration of favorable tolerability profile generally consistent with previously reported data; over 800 patients treated across the greater nemvaleukin clinical program
The company remains on track to share topline results from potentially registrational, phase 2 trial in mucosal melanoma, ARTISTRY-6, Cohort 2, evaluating nemvaleukin monotherapy in Q2 2025
WALTHAM, Mass and DUBLIN, March 25, 2025 (GLOBE NEWSWIRE) -- Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, today announced that the ARTISTRY-7 phase 3 trial of nemvaleukin alfa in combination with Merck’s (known as MSD outside the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) versus investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer (PROC) will not continue to final analysis and the company will cease development of nemvaleukin for PROC. In the pre-specified interim analysis conducted by the independent data monitoring committee, nemvaleukin in combination with pembrolizumab did not achieve a statistically significant improvement in overall survival versus investigator’s choice chemotherapy alone and the company believes the study is highly unlikely to achieve success at the final analysis. Median overall survival was 10.1 months for patients treated with nemvaleukin in combination with pembrolizumab and 9.8 months for patients treated with investigator’s choice chemotherapy (hazard ratio: 0.98).
“We are disappointed for ovarian cancer patients desperately lacking new treatment options. There has been a great deal of work across the industry in this immunologically cold tumor, yet there are still few treatment options that improve survival in this very difficult-to-treat tumor type. We are still on track to report topline data from our potentially registrational trial in mucosal melanoma later next quarter and will assess all available data to inform our next steps,” said Caroline Loew, Ph.D., CEO of Mural Oncology.
Nemvaleukin has a well characterized and favorable safety profile, both as a monotherapy and in combination with pembrolizumab, with over 800 patients treated across the broader clinical program. In the interim analysis of ARTISTRY-7, the safety profile was generally consistent with previously reported data.
Nemvaleukin is currently being evaluated in a potentially registrational, phase 2 trial, ARTISTRY-6, cohort 2 in mucosal melanoma, with a topline data readout expected in Q2 2025. Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma are expected in the second quarter of 2025 for cohort 3 of ARTISTRY-6 (monotherapy) and the second half of 2025 for cohort 4 of ARTISTRY-6 (combination therapy), subject to patient enrollment.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the ARTISTRY-7 Trial
ARTISTRY-7 is a phase 3 trial comparing nemvaleukin in combination with pembrolizumab vs. investigator choice single agent chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, with a primary endpoint of overall survival. This four-arm trial also contains two smaller single agent arms, a pembrolizumab and a nemvaleukin arm, to assess contribution of components. A total of 456 patients were enrolled over the four arms of the trial in an approximate 3:1:1:3 randomization. Only arms 1 (nemvaleukin in combination with pembrolizumab) and 4 (investigator’s choice chemotherapy) were designed to be assessed for statistical comparisons. The pre-specified interim analysis was conducted at
About Nemvaleukin
Nemvaleukin alfa (nemvaleukin) is an engineered fusion protein designed to leverage IL-2’s antitumor effects while mitigating the hallmark toxicities that limit its use. Nemvaleukin selectively binds to the intermediate-affinity IL-2 receptor (IL-2R) and is sterically occluded from binding to the high-affinity IL-2R. Because of this molecular design, nemvaleukin treatment leads to preferential expansion of antitumor CD8+ T cells and natural killer cells, with minimal expansion of immunosuppressive regulatory T cells. Nemvaleukin is currently being evaluated in a potentially registrational trial, ARTISTRY-6, cohort 2 in mucosal melanoma, with a topline readout expected in Q2 2025. Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma are expected in the second quarter of 2025 for cohort 3 of ARTISTRY-6 (monotherapy) and the second half of 2025 for cohort 4 of ARTISTRY-6 (combination therapy), subject to patient enrollment.
About Mural Oncology
Mural Oncology is leveraging its novel protein engineering platform to develop cytokine-based immunotherapies for the treatment of cancer. By combining our expertise in cytokine biology and immune cell modulation and our protein engineering platform, we are developing medicines to deliver meaningful and clinical benefits to people living with cancer. Our mission is to broaden the potential, and reach, of cytokine-based immunotherapies to improve the lives of patients. Our lead candidate, nemvaleukin, is currently being evaluated in a potentially registrational trial, ARTISTRY-6, cohort 2 in mucosal melanoma, with a topline readout expected in Q2 2025. Preliminary data readouts for less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma are expected in the second quarter of 2025 for monotherapy and the second half of 2025 for combination therapy. Mural Oncology has its registered office in Dublin, Ireland, and its primary facilities in Waltham, Mass. For more information, visit Mural Oncology’s website at www.muraloncology.com and follow us on LinkedIn, Bluesky, and X.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the company’s pipeline and development programs, including the expected timing of data readouts from the ARTISTRY-6 trial, the potential of the company’s product candidates and programs to address unmet medical needs, the continued progress of its pipeline and programs, and the sufficiency of Mural’s cash resources for the period anticipated. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, the inherent risks and uncertainties associated with competitive developments, preclinical development, clinical trials, recruitment of patients, product development activities and regulatory approval requirements; that preclinical or interim results and data from ongoing clinical studies of the company’s cytokine programs and product candidates may not be predictive of future or final results from such studies, results of future clinical studies or real-world results; future clinical trials or future stages of ongoing clinical trials may not be initiated or completed on time or at all; the company’s product candidates, including nemvaleukin, could be shown to be unsafe or ineffective; changes in the cost, scope and duration of development activities; the U.S. Food and Drug Administration may make adverse decisions regarding the company’s product candidates; and those other risks and uncertainties set forth in the company’s filings with the Securities and Exchange Commission (“SEC”), including its Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in subsequent filings the company may make with the SEC. All forward-looking statements contained in this press release speak only as of the date of this press release. The company anticipates that subsequent events and developments will cause its views to change. However, the company undertakes no obligation to update such forward-looking statements to reflect events that occur or circumstances that exist after the date of this press release, except as required by law.
Contact:
Katie Sullivan
katie.sullivan@muraloncology.com
FAQ
What were the survival rates in MURA's ARTISTRY-7 trial for ovarian cancer?
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