Dr Kyriakopoulos on the Investigation of Masofaniten Plus Enzalutamide in mCRPC

Welcome to OncLive On Air^®! I’m your host today, Courtney Flaherty.

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, sponsored by Essa Pharmaceuticals, we had the pleasure of speaking with Christos Kyriakopoulos, MD, about initial results from an ongoing phase 1/2 trial (NCT05075577) of oral masofaniten (EPI-7386) in combination with enzalutamide (Xtandi) in patients with metastatic castration-resistant prostate cancer (mCRPC). Dr Kyriakopoulos is a medical oncologist and an associate professor in the Department of Medicine, Division of Hematology, Medical Oncology and Palliative Care at the University of Wisconsin School of Medicine and Public Health in Madison.

The open-label, multicenter trial is investigating the safety, pharmacokinetics and preliminary antitumor activity of the combination compared with enzalutamide monotherapy in patients receiving androgen deprivation therapy who are naive to second-generation anti-androgen agents. Masofaniten is being evaluated in a dose-escalation portion of the trial, as well as in a phase 2 dose-expansion cohort.

Preliminary dose-escalation data presented at the 2024 Genitourinary Cancers Symposium showed that masofaniten plus enzalutamide was well tolerated with a favorable safety profile and yielded rapid and lasting decreases in prostate-specific antigen (PSA) levels. Notably, 81% of patients experienced a PSA level decrease of over 90%, with 63% of patients achieving this reduction within 90 days. PSA responses were observed across all starting PSA levels, and efficacy data on disease progression are still evolving. The recommended phase 2 dose of enzalutamide was established at the full approved dose of 160 mg daily plus 600 mg of masofaniten twice daily to offset masofaniten's impact on exposure caused by its interaction with enzalutamide.

Based on these results, the 2-arm dose-expansion phase of the trial has commenced and is enrolling patients at multiple sites in the United States, Canada, and Australia.

In our exclusive interview, Dr Kyriakopoulos shed light on the potential synergy and pharmacokinetic interactions between masofaniten and enzalutamide when used in combination for patients with prostate cancer; contextualized safety and pharmacokinetic findings from the phase 1 portion of the study; and outlined key objectives of the agent’s ongoing evaluation in the phase 2 portion of the study.

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