Despite advances in the treatment of HR-positive HER2-negative advanced breast cancer, patients with PIK3CA-mutated disease who progress after a CDK4/6 inhibitor still face limited effective and tolerable treatment options.1 This unmet need has fueled interest in zovegalisib (formerly RLY-2608), a next generation, pan-mutant-selective PI3Kα inhibitor designed to spare wild-type protein and potentially reduce class-related toxicities.2 Dr. Sarah Sammons joins Dr. Charles Turck to review key findings from the first-in-human ReDiscover trial of zovegalisib + fulvestrant that supported initiation of the Phase 3 ReDiscover-2 study3,4, which is currently enrolling. They also discuss ReDiscover-2 eligibility criteria, along with patient selection and screening considerations, using hypothetical case scenarios. Dr. Sammons is the Associate Director of the Metastatic Breast Cancer Program at the Dana-Farber Cancer Institute in Boston, Massachusetts.

References:

1. Mishra R, Patel H, Alanazi S, Kilroy MK, Garrett JT. PI3K inhibitors in cancer: clinical implications and adverse effects. Int J Mol Sci. 2021;22(7)doi:10.3390/ijms22073464
2. Varkaris A, Pazolli E, Gunaydin H, et al. Discovery and clinical proof-of-concept of RLY-2608, a first-in-class mutant-selective allosteric PI3Kα inhibitor that decouples antitumor activity from hyperinsulinemia. Cancer Discovery. 2024;14(2):240–257. doi:10.1158/2159-8290.cd-23-0944
3. ClinicalTrials.gov. NCT06982521. Accessed April 12, 2026. https://clinicaltrials.gov/study/NCT06982521
4. Rugo HS, Saura C, Jhaveri K, et al. Poster PS5-08-25: …

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This is a non-certified educational series produced and controlled by ReachMD.

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