Komal Jhaveri: The triplet with fulvestrant backbone yielded a mPFS of 35 months in HER2-negative breast cancer

Komal Jhaveri, Patricia and James Cayne Chair for Junior Faculty, Associate Member, Breast Medicine and Early Drug Development Service at Memorial Sloan Kettering Cancer Center, posted the following on LinkedIn:

“Results from the phase 1/1b trial of Inavolisib plus Palbociclib plus Endocrine therapy in PIK3CA mutated HR Pos HER2 negative metastatic breast cancer now published.

No Drug-Drug Interaction, most common treatment-related adverse events were hyperglycemia, stomatitis, and diarrhea. The triplet with fulvestrant backbone yielded a mPFS of 35 months. These data formed the basis for the phase 3 INAVO120 trial that has since demonstrated near doubling of mPFS from 7 to 15 months with the addition of Inavolisib compared to fulvestrant and palbociclib in 1L metastatic setting in PIK3CA mutated endocrine resistant disease.

Inavolisib now has BTD and priority review by US FDA is expected by Nov 27 2024.”

Phase I/Ib Trial of Inavolisib Plus Palbociclib and Endocrine Therapy for PIK3CA-Mutated, Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced or Metastatic Breast Cancer

Authors: Komal L. Jhaveri, MD, FACP, Melissa K. Accordino, MD, Philippe L. Bedard, MD, Andrés Cervantes, MD, Valentina Gambardella, MD, Erika Hamilton, MD, Antoine Italiano, MD, Kevin Kalinsky, MD, Ian E. Krop, MD, Mafalda Oliveira, MD, Peter Schmid, MD, Cristina Saura, MD, Nicholas C. Turner, MD, Andrea Varga, MD, Sravanthi Cheeti, MS, Stephanie Hilz, PhD, Katherine E. Hutchinson, PhD, Yanling Jin, PhD, Stephanie Royer-Joo, Engr, Ubong Peters, PhD, Noopur Shankar, MD, PhD, Jennifer L. Schutzman, MD, PhD, and Dejan Juric, MD

Source: Komal Jhaveri/LinkedIn