In today’s episode, we spoke with Adam M. Brufsky, MD, PhD, about the FDA approval of gedatolisib (Revtorpyk) plus fulvestrant (Faslodex), with or without palbociclib (Ibrance), for the treatment of adult patients with hormone receptor–positive, HER2-negative advanced breast cancer without a PIK3CA mutation following progression on or after treatment with 1 or more lines of endocrine therapy in the metastatic setting. Dr Brufsky is a professor of medicine and the associate division chief for the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh School of Medicine; as well as medical director of the Magee-Women’s Cancer Program, associate director for clinical investigations, and codirector of the Comprehensive Breast Cancer Center at the University of Pittsburgh Medical Center Hillman Cancer Center, in Pennsylvania.<br>In our exclusive interview, Dr Brufsky highlighted the significance of this approval, key efficacy and safety data from Study 1 of the phase 3 VIKTORIA-1 trial (NCT05501886) that supported this regulatory decision, and what the future may hold for metastatic breast cancer management strategies.

FDA Approval Insights: Gedatolisib Plus Fulvestrant ± Palbociclib for HR+, HER2-Negative, PIK3CA Wild-Type Advanced Breast Cancer: With Adam M. Brufsky, MD, PhD

OncLive® On Air

Welcome to OncLive On Air. I'm your host today, Aisling Wehner. In today's episode, we spoke with Adam M. Brufsky, MD, PhD, about the FDA approval of Gedatolisib plus Fulvestrant with or without Palbociclib for the treatment of adult patients with hormone receptor positive HER2-Negative advanced breast cancer without a PIK3CA mutation following progression on or after treatment with one or more lines of endocrine therapy in the metastatic setting.

In our exclusive interview, Dr. Brufsky highlighted the significance of this approval, key efficacy and safety data from Study 1 of the Phase III Victoria I trial that supported this regulatory decision, and what the future may hold for metastatic breast cancer management strategies. Dr. This is pretty huge. I mean, this drug only has one real downside, and we'll talk about that in a minute.

But if this is an oral agent, it was to become the standard of care for CDK4-6 progression in somebody who doesn't have a mutation in ESR1 or a PA3 kinase. The trial, Victoria I, had two parts. It had a—it get it all, so it was intravenous, first of all. It's intravenous PA3 kinase combination mTOR inhibitor.

It's intravenous, it's intravenous, it was developed by Pfizer, abandoned by them, or actually sold, not abandoned, sold to Cellcuity for $10 million about six years ago. So Cellcuity decided to develop the drug in a Phase III trial against the standard of care at the time after progression on an AI and a CDK4-6 inhibitor for first-line hormone receptor positive metastatic breast cancer.

And it was—the trial was basically fulvestrant versus Gedatolisib fulvestrant versus Gedatolisib paldocyclic fulvestrant. And this is in wild type, so ESR1 wild type, or ESR1 unknown, let's put it that way, PA3 kinase wild type.

FDA Approval Insights: Gedatolisib Plus Fulvestrant ± Palbociclib for HR+, HER2-Negative, PIK3CA Wild-Type Advanced Breast Cancer: With Adam M. Brufsky, MD, PhD

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The candid version is on a podcast,
not the earnings call.

FDA Approval Insights: Gedatolisib Plus Fulvestrant ± Palbociclib for HR+, HER2-Negative, PIK3CA Wild-Type Advanced Breast Cancer: With Adam M. Brufsky, MD, PhD

Read the full transcript

The candid version is on a podcast, not the earnings call.

The candid version is on a podcast,
not the earnings call.