Capivasertib and Fulvestrant for Pts With AI-Resistant HR+/HER2 ABC

For the study, patients (pts) were randomly assigned in a 1:1 ratio to receive fulvestrant (fulv) (500 mg IM on days 1 and 15 of cycle 1, and day 1 of each subsequent 28-day cycle), with either placebo or capivasertib (400 mg twice daily; 4 days on, 3 days off). The analysis of data was divided based on the occurrence of liver metastases, prior usage of CDK4/6 inhibitor, and region. The scheduled exploratory PFS analyses considered the previous use of CDK4/6i, prior chemotherapy (CT) for ABC, and the presence of liver metastases.

A total of 708 pts were randomly assigned to either capivasertib-fulv (n=355) or placebo-fulv (n=353). Out of these, 289 pts (40.8%) had AKT pathway-altered tumors, 496 pts (70.1%) had received CDK4/6i previously, 129 pts (18.2%) had undergone CT for ABC in the past, and 306 pts (43.2%) had liver metastases. The consistency of the PFS benefit of capivasertib-fulv over placebo-fulv was observed among key clinical subgroups. Furthermore, the findings in the AKT pathway-altered population were in line with those of the overall population.

The exploratory PFS analyses confirmed that capivasertib-fulv treatment outperforms fulv alone in various subgroups, including pts with CDK4/6i exposure, liver metastases, and poor prognosis on fulv alone.

Source: https://oncologypro.esmo.org/meeting-resources/esmo-breast-cancer-congress/capivasertib-and-fulvestrant-for-patients-pts-with-aromatase-inhibitor-ai-resistant-hr-her2-advanced-breast-cancer-abc-subgroup-analyses-from-the-phase-3-capitello-291-trial

Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04305496

Oliveira, M., Rugo, H.S., Howell, S.J., Dalenc, F., Cortes, J., Gomez Moreno, H.L., Hu, X., Jhaveri, K., Loibl, S., Morales, S., Okera, M., Park, Y.H., Sohn, J., Tokunaga, E., Zhukova, L., Wadsworth, I., Schiavon, G., Foxley, A., Turner, N. Annals of Oncology (2023) 8 (1suppl_4): 101223-101223. 10.1016/esmoop/esmoop101223