Nemvaleukin Alfa Development Halted in Ovarian Cancer

Detailed illustration of the human female reproductive system on black background. Neon uterus and ovaries. Uterus, Female reproductive system anatomy, Women uterus and ovary icon: Firefly

The combination of nemvaleukin alfa (ALKS 4230) and pembrolizumab (Keytruda) did not achieve a statistically significant improvement in overall survival (OS) vs investigator’s choice of chemotherapy in the phase 3 ARTISTRY-7 trial (NCT05092360) for patients with platinum-resistant ovarian cancer.¹

According to findings from the prespecified interim analysis conducted by the independent data monitoring committee, the median OS for those treated with the combination was 10.1 months vs 9.8 months for patients treated with investigator’s choice chemotherapy (HR, 0.98). The company does not believe it is likely the combination would achieve success at the final analysis.

As a result, the study will not continue to final analysis and the company will halt the development of nemvaleukin for this patient population.

“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, PhD, chief executive officer of Mural Oncology, in a press release.

The phase 3, multicenter, open-label, randomized ARTISTRY-7 trial sought to evaluate nemvaleukin plus pembrolizumab compared with investigator choice of single-agent chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. A total of 456 patients were enrolled in the 4-arm study in an approximate 3:1:1:3 randomization.²

Arms 1 and 4, which were given nemvaleukin in combination with pembrolizumab and investigator’s choice chemotherapy, were designed to be assessed for statistical comparisons. The prespecified interim analysis was conducted at 219 (77%) events needed for the final analysis.

The primary end point was OS. Secondary end points were overall response rate, disease control rate, duration of response, time to response, cancer antigen-125 response as defined by the Gynecologic Cancer InterGroup, incidence of treatment-emergent adverse events, and progression-free survival assessed by investigators.

Despite the negative OS findings, nemvaleukin was shown to have a favorable safety profile when given as a monotherapy and in combination with pembrolizumab.¹ The safety profile of the agent in the interim analysis of ARTISTRY-7 was generally consistent with previously reported data.

Nemvaleukin is currently being assessed in ARTISTRY-6 (NCT04830124), a registrational phase 2 trial, with cohort 2 focusing on patients with mucosal melanoma. Topline results from this cohort are anticipated later in 2025. Additionally, preliminary data for less-frequent intravenous dosing in cutaneous melanoma patients are also expected in 2025 for cohort 3 (monotherapy) and in the second half of 2025 for cohort 4 (combination therapy), contingent upon patient enrollment.

References:

1. Mural Oncology provides update on phase 3 ARTISTRY-7 trial of nemvaleukin in combination with KEYTRUDA® (pembrolizumab) in patients with platinum-resistant ovarian cancer. News release. Mural Oncology, Inc. March 25, 2025. Accessed March 25, 2025. https://tinyurl.com/ydbaajtc

2. Phase 3 study of nemvaleukin alfa in combination with pembrolizumab in patients with platinum-resistant epithelial ovarian cancer (ARTISTRY-7) (ARTISTRY-7). ClinicalTrials.gov. Updated June 28, 2024. Accessed March 25, 2025. https://clinicaltrials.gov/study/NCT05092360?tab=table