Mural Oncology (NASDAQ: MURA) provided key updates on its clinical programs, including nemvaleukin and its IL-18 program, during its virtual Investor Day. The company highlighted the progress of its ARTISTRY-7 and ARTISTRY-6 trials and outlined the expected timelines for data readouts and regulatory submissions.
Nemvaleukin Clinical Trials
Nemvaleukin, Mural Oncology's lead candidate, is an engineered IL-2 cytokine designed to enhance anti-tumor effects while reducing toxicity. It is currently being evaluated in two potentially registrational trials: ARTISTRY-7 and ARTISTRY-6.
ARTISTRY-7: Platinum-Resistant Ovarian Cancer
The ARTISTRY-7 trial is a phase 3 study comparing nemvaleukin in combination with pembrolizumab against investigator's choice single-agent chemotherapy in patients with platinum-resistant ovarian cancer (PROC). The primary endpoint is overall survival (OS).
Enrollment in the ARTISTRY-7 trial is complete, with 456 patients enrolled. An interim analysis for OS is estimated to occur by late Q4 2024 or early Q1 2025, with the data readout expected in late Q1 or early Q2 2025. According to Mural Oncology, if the hazard ratio meets the bar for success, the study will be declared positive, and the company will plan to file a Biologics License Application (BLA) in 2025.
The protocol assumes a median OS of 10 months for the chemotherapy control arm and a median OS of 14.3 months for the nemvaleukin plus pembrolizumab arm. The maximum hazard ratio for success at the interim analysis is 0.727, indicating a 27.3% reduction in the risk of death.
Caroline Loew, Ph.D., CEO of Mural Oncology, stated, "Mural has the most advanced IL-2 program currently in development and we have made significant progress this year. We have a great deal of conviction around nemvaleukin, which is engineered to unlock the efficacy potential of high dose IL-2 for more patients."
ARTISTRY-6: Mucosal Melanoma
The ARTISTRY-6 trial is a phase 2 study focusing on mucosal melanoma, a rare and aggressive form of cancer with no currently approved treatments. The trial is evaluating single-agent nemvaleukin in patients with unresectable or metastatic mucosal melanoma. The primary endpoint is overall response rate (ORR) evaluated per RECIST 1.1 by an independent central radiology review.
Enrollment in the ARTISTRY-6 trial is complete, with 92 patients enrolled. Top-line results are expected in Q2 2025. The target response rate is 25%, and Mural believes that demonstrating durable responses with a response rate of 20-25% would be meaningful for patients and support a discussion with the FDA regarding a potential BLA submission and potential accelerated approval.
Nemvaleukin has received both FDA Fast Track Designation and Orphan Drug Designation for the treatment of mucosal melanoma.
IL-18 Program
Mural Oncology is also advancing its IL-18 program, which aims to develop therapies that enhance immune responses against tumors. The company plans to nominate a development candidate for its IL-18 program by the end of 2024 and intends to submit an Investigational New Drug (IND) Application to the FDA in Q4 2025.
Financial Position
Mural Oncology reported a cash balance of approximately $200 million as of Q2 2024, which is expected to fund operations into Q4 2025.
