Novartis' Kisqali Dramatically Improves Overall Survival in Hard-to-Treat Breast Cancer

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At the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting, Novartis presented results from the MONALEESA-7 Phase III clinical trial of Kisqali plus endocrine therapy in pre- and perimenopausal women with HER+/HER2- advanced or metastatic breast cancer. The data will also be published in The New England Journal of Medicine.

Kisquali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as an initial treatment was compared to endocrine therapy alone in pre- and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Overall survival rates in the intent-to-treat population at 42 months for the Kisquali combination group was 70.2% compared to 46.0% for hormone therapy alone. At the cut-off time for the interim analysis, 35% of women on the Kisqali combination therapy were continuing treatment.

The company notes that Kisqali is not indicated for use with tamoxifen.

Kisqali (ribociclib) is a CDK4/6 inhibitor. So far, it is the only targeted therapy, including other CDK4/6 inhibitors, in combination with endocrine therapy to show significantly longer overall survival compared to endocrine therapy alone as an initial endocrine-based treatment for advanced breast cancer. Follow-up on overall survival is ongoing for both the MONALEESA-2 and MONALEESA-3 trials.

Kisqali was initially approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in August 2018, as initial endocrine-based treatment for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. It was later approved in combination with an aromatase inhibitor for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy and in combination with fulvestrant as first or second-line therapy in postmenopausal women.

“Overall survival benefit is considered the ‘gold standard’ in cancer trials but is challenging to achieve in HR+/HER2- metastatic breast cancer,” stated Sara Hurvitz, Medical Director of the Jonsson Comprehensive Cancer Center Clinical Research Unit and Director of the Breast Cancer Clinical Trials Program at UCLA. “MONALEESA-7 reached this important endpoint earlier than anticipated. Impactful results like these ribociclib findings are what we wish for in every clinical trial, and to achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement for patients.”

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The big competitor for Kisqali is Pfizer’s Ibrance. The results from this trial should give Kisqali a bit of a boost in competing with Pfizer’s drug. Another similar, competitive drug is Eli Lilly’s Verzenio.

“Kisqali has characteristics that make it distinct from other CDK4/6 inhibitors,” stated Jeff Engelman, Global Head of Oncology Research, Novartis Institutes for BioMedical Research. “In pre-clinical data, Kisqali is four- to five-fold more potent against CDK4 compared to CDK6. CDK4 is likely the dominant CDK in breast cancer and a pivotal driver of disease progression.”

In a subgroup analysis, Kisqali and an aromatase inhibitor showed a 30.0% decreased risk of death compared to an aromatase inhibitor alone, and Kisqali with tamoxifen showed a 20.9% decreased risk of death compared to tamoxifen alone.

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