Virginia Kaklamani, MD

Virginia Kaklamani, MD, Professor of Medicine at the University of Texas (UT) Health Science Center San Antonio and leader of the Breast Cancer Program at UT Health San Antonio MD Anderson Cancer Center, was enthusiastic about the results of the phase III CAPItello-291 trial.

“The phase III CAPItello trial enrolled patients with estrogen receptor–positive, HER2-negative, metastatic breast cancer who were randomly assigned to capivasertib plus fulvestrant or placebo plus fulvestrant. The combination arm of capivasertib plus fulvestrant outperformed fulvestrant. The main side effects of capivasertib were rash and diarrhea,” she said.

“The data are good. You need to consider which patients with hormone receptor–positive, HER2-negative, metastatic breast cancer are appropriate for monotherapy and who is appropriate for combination therapy.Patients with endocrine-resistant disease are appropriate for combination therapy, but the way to determine that is by clinical features [including the duration of endocrine therapy], and this is not an optimal method. Mechanisms of resistance are different for each drug,” she continued.

“The takeaway message of CAPItello is that capivasertib is an exciting new drug that is an AKT inhibitor. It seems to be active in all patients regardless of activity in the AKT pathway, so it looks like it doesn’t need a marker,” Dr. Kaklamani said. “It looks like it will be a good option for the right patient as second-line therapy.” 

DISCLOSURE: Dr. Kaklamani has received speakers fees from Pfizer, Gilead, Genentech, Exact Sciences, Novartis, AstraZeneca, Daiichi Sankyo, and Seagen; has served as a consultant to AstraZeneca, Daiichi Sankyo, Menarini, and Gilead Sciences; and has conducted research for Eisai.