Kisqali data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancer.- Novartis

Novartis announced new Kisqali (ribociclib) data demonstrating consistent efficacy benefit with Kisqali plus endocrine therapy across the main intrinsic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer. The largest biomarker analysis of efficacy in intrinsic subtypes evaluated whether there was a correlation between these subtypes and efficacy outcomes in patients treated with Kisqali across the three Phase III MONALEESA trials1. The findings will be presented in an oral presentation at the 2020 San Antonio Breast Cancer Virtual Symposium. This broad ad hoc exploratory analysis showed that Kisqali plus endocrine therapy consistently provided significant progression-free survival (PFS) benefit across three of four subtypes of HR+/HER2- metastatic breast cancer (LumA HR=0.63; p<.001, lumb hr="0.52;" p><.001, her2-enriched hr="0.39;" p><.001, basal-like hr="1.15;" p=".7672)." the largest pfs benefit was seen in patients with the her2-enriched subtype – a non-luminal subtype associated with endocrine resistance and poor prognosis. in contrast, benefit was not observed with palbociclib in the her2-enriched subtype in a retrospective analysis of the paloma-2 trial presented at the 2017 san antonio breast cancer symposium . “the significant benefit seen with ribociclib in the endocrine-resistant her2-enriched subtype is a unique and important finding, differentiating it from the other cdk4 6 inhibitors. the underlying hypothesis is that ribociclib induces hormone-sensitivity in this group of tumors beyond inhibition of the cell-cycle,” said aleix prat, head, department of medical oncology, hospital clinic, barcelona, spain. “the body of preclinical data showing that ribociclib has the ability to more selectively target and inhibit cdk4, which is a key driver of disease progression in breast cancer, may help us understand why ribociclib provides consistent benefit, especially in patients with more aggressive disease.” the four intrinsic subtypes of breast cancer (luminal a, luminal b, her2-enriched and basal-like) have revealed critical differences in terms of incidence, survival and response to treatment. additionally, the insights provided by intrinsic subtypes complement and expand upon the information provided by standard clinical parameters and pathological markers. the observed benefit with kisqali provides reassurance about it as a treatment choice for the majority of people with metastatic breast cancer without the need for additional testing.>