Development of Nemvaleukin for Platinum-Resistant Ovarian Cancer Halted

The ARTISTRY-7 phase 3 trial that is evaluating nemvaleukin alfa in combination with Keytruda (pembrolizumab) versus an investigator’s choice of chemotherapy among patients with platinum-resistant ovarian cancer will not continue on to its final analysis, with manufacturer Mural Oncology plc to cease development of nemvaleukin for patients with platinum-resistant ovarian cancer.

The update was announced in a news release by Mural Oncology plc, a clinical-stage immune-oncology company, which noted that in the pre-specified interim analysis that was conducted by an independent data monitoring committee, the combination of nemvaleukin and Keytruda did not result in a statistically significant improvement in overall survival when compared to treatment with chemotherapy alone.

The company reported that the median overall survival was 10.1 months among patients treated with nemvaleukin and Keytruda, and it was 9.8 months for patients who received treatment with the investigator’s choice of chemotherapy.

“We are disappointed for [patients with ovarian cancer who are] 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, CEO of Mural Oncology, in the news release.

Nemvaleukin, as defined by the National Cancer Institute, is a selective effector cell activator protein and agonist of the intermediate-affinity interleukin-2 (IL-2) receptor with potential immune-stimulating and antineoplastic activity.

Nemvaleukin is intended to bind to and signal through the intermediate-affinity IL-2 receptor complex, which in turn may selectively stimulate and activate natural killer (NK) cells and memory CD8 T-cells, leading to tumor cell elimination, while circumventing the activation of immunosuppressive cells that may prevent the anti-tumor response, as the National Cancer Institute explained.

The drug is also currently being evaluated in the potentially registrational phase 2 trial ARTISTRY-6’s cohort 2 in mucosal melanoma, with Mural Oncology saying in the news release that a topline data readout is expected in the second quarter of 2025. Additionally, preliminary data readouts for less-frequent intravenous dosing of nemvaleukin for patients with cutaneous melanoma are also expected in the second quarter of the year as a monotherapy in cohort 3 of ARTISTRY-6 and in the second half of the year as a combination therapy in cohort 4 of ARTISTRY-6, although this is subject to patient enrollment.

ARTISTRY-7, as explained by Mural Oncology in the news release, is evaluating nemvaleukin plus Keytruda versus single-agent chemotherapy among patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer, with 456 patients being enrolled across the trial’s four arms. The trial, according to its listing on clinicaltrials.gov, has an estimated primary completion date of May 2026, and an estimated study completion date of May 2027. It is being held at 117 locations around the world.

Platinum-resistant cancer, as explained by the National Cancer Institute, is cancer that at first responds to treatment with drugs that contain the metal platinum, such as the chemotherapies cisplatin and carboplatin, but then comes back in a certain window of time, with the National Cancer Institute noting that ovarian cancer that comes back within six months is considered platinum resistant.

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