Mitigating Stomatitis and Optimizing Gedatolisib Treatment in Breast Cancer

With the FDA approval of the multi-target PAM inhibitor gedatolisib (Revtorpyk) for hormone receptor–positive, HER2-negative metastatic breast cancer, proper adverse effect (AE) mitigation has become a primary focus for oncology care teams.¹ Among the key safety parameters identified in the phase 3 VIKTORIA-1 trial (NCT05501886), stomatitis emerged as a notable AE requiring proactive clinical intervention.²

Sara Hurvitz, MD, FACP, broke down the historical context and modern strategies for managing oral toxicities induced by pathway inhibitors. Drawing parallels to past experiences with everolimus (Afinitor), Hurvitz detailed the critical role of mandatory prophylactic steroid mouthwashes used within the trial design. She emphasized the vital importance of patient-provider partnership, early intensive monitoring, and targeted patient education regarding dietary choices and meticulous oral hygiene routines to ensure patients maintain an optimal quality of life during the critical initial cycles of treatment.

Hurvitz is a physician, senior vice president and director of the Clinical Research Division, a professor of the Clinical Research Division, and Smith Family Endowed Chair in Women’s Health at Fred Hutch.

Transcript:

VIKTORIA-1 did implement a mandatory oral steroid mouthwash, which was utilized in patients receiving everolimus after we experienced such tremendous stomatitis with everolimus when it was approved back around 2012. That impacted our ability to safely and effectively deliver everolimus. The mechanism of action of stomatitis with an IV-formulated PAM inhibitor is maybe a little bit different, so in addition to the oral steroid mouthwash, we need to get patients to partner with us on their careful oral care; avoiding very rough, very hot, or spicy foods; and just making sure that they’re very aware of oral care and the foods and drinks that they are taking in. It is notable that the stomatitis seems to be early onset and gets better. We don’t see it after a couple of cycles, so that intensive monitoring and guidance of patients early on is going to be key in helping them tolerate [gedatolisib] and have a better quality of life.

References

1. FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer. News release. FDA. July 14, 2026. Accessed Jully 15, 2026. https://tinyurl.com/yck3eabf
2. Hurvitz SA, Layman RM, Curigliano G, et al. Gedatolisib Plus fulvestrant, with & without palbociclib, vs fulvestrant in patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer: first results from VIKTORIA-1. Presented at: 2025 ESMO Annual Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA17.