Hormonal therapy with Ribociclib Plus prolongs the survival of patients with late-stage advanced hormone receptor breast cancer

SUMMARY LBA1008

The addition of targeted ribociclib therapy to hormone therapy has significantly improved overall survival in premenopausal patients with advanced hormone receptor-positive bad cancer (HR +), according to the results of The MONALEESA-7 Phase III clinical trial conducted by researchers at the University of Texas. MD Anderson Cancer Center.

The combination resulted in a 70.2% OS at 42-month follow-up, compared to only 46% in patients receiving hormone therapy with placebo. This corresponds to a risk of death reduced by 29% in patients receiving the combination therapy. The authors also reported no new side effects compared to those previously described. This is the first demonstration of a survival benefit through the addition of a biological therapy to hormone therapy.

The results of the test published this month in the New England Journal of Medicine and will be presented at the annual meeting of the ASCO (American Society of Clinical Oncology) in 2019. Current results are based on the main evaluation criteria previously reported at the Breast Cancer Symposium. 2017 in San Antonio and published in Oncology Lancet.

"The data from MONALEESA-7 clearly demonstrate that ribociclib offers a significant survival advantage over hormone therapy alone in non-premenopausal patients," said lead author Debu Tripathy, MD, president of Breast Medical Oncology. "Breast cancer in younger women is known to be more aggressive and have distinct genetic alterations compared to menopausal patients, which is therefore an essential therapeutic option for these patients."

Ribociclib is part of a clbad of drugs that inhibit cyclin-dependent 4/6 kinases (CDK4 / 6), proteins required for cell cycle progression. In 2018, ribociclib became the first CDK 4/6 inhibitor approved by the Food and Drug Administration for the treatment of premenopausal patients with advanced HR + bad cancer in combination with hormonal therapies.

The randomized international Phase III clinical trial included 672 patients with metastatic bad cancer, all pre- or post-menopausal (having stopped menstruating within the last year) at the time diagnosis of HR +, HER2-negative disease. Participants would not have been able to undergo prior hormonal therapy for advanced disease nor more than one chemotherapy cycle for advanced disease.

Patients were randomized to receive either ribociclib (335) or placebo (337) in combination with tamoxifen or a non-steroidal aromatase inhibitor (NSAI), and goserelin, an anti-inflammatory drug. ovarian. In the ribociclib group, 87 patients (26%) received tamoxifen compared to 90 patients (26.7%) in the placebo group.

The median duration of treatment with ribociclib was approximately two years, eight months more than at the time of primary badysis of progression-free survival. No new toxic effects emerged with longer follow-up. The most common adverse event was neutropenia, occurring in 63.5% of patients in the ribociclib group, compared to 4.5% of patients in the placebo group. Hepatobiliary toxic effects were observed in 11% and 6.8% respectively.

"This study confirms that the benefits of these drugs are similar in pre- and postmenopausal patients with advanced hormone-receptor-positive bad cancer, and it further confirms the clinical value of the addition of ribociclib for these patients, "said Tripathy.

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The study was sponsored by Novartis Pharmaceuticals Corporation, which markets ribociclib (Kisqali). Tripathy is a paid consultant for Novartis and MD Anderson has received funding from Novartis to conduct this study. A complete list of collaborating researchers and their revelations are included in the document.