Novartis' Kisqali extends PFS by 1 year for advanced breast cancer patients

Novartis Korea said on Monday that its advanced and metastatic breast cancer treatment Kisqali (ingredient: ribociclib) extended progression-free survival (PFS) by about one year compared to combination chemotherapy in first-line treatment of patients with aggressive premenopausal and HER2-advanced breast cancer.

Kisqali is a CDK4/6 inhibitor, which was approved by the Ministry of Food and Drug Safety (MFDS) in October 2019 as a combination therapy with aromatase inhibitors as first-line endocrine therapy in premenopausal, transitional, or postmenopausal women, with advanced or metastatic breast cancer who are hormone receptor-positive, human epithelial growth factor receptor 2 negative (HR+/HER2-), or advanced disease progression after endocrine therapy.

The results of this study were presented at the San Antonio Breast Cancer Conference (SABCS 2022) held from Dec. 6-10.

Currently, CDK4/6 inhibitors and endocrine therapy are used as the standard treatment in the primary treatment of HR+/HER2-progressive breast cancer patients, but combination chemotherapy is still used in patients with rapid disease progression.

The RIGHT Choice study is the first open-label, multinational, randomized Phase 2 clinical study comparing CDK4/6 inhibitors + endocrine therapy combination therapy with chemotherapy in patients with aggressively advanced premenopausal and postmenopausal HR+/HER2-advanced breast cancer.

The study was conducted in 222 patients. 

Kisqali + endocrine therapy (letrozole or anastrozole + goserelin) and combination chemotherapy (docetaxel + capecitabine, paclitaxel + gemcitabine, capecitabine + vinorelbine) were allocated in a 1:1 ratio, and PFS was evaluated as the primary endpoint.

Accordingly, the results showed that the median PFS in the Kisqali combined group was 24 months, an extension of about one year from 12.3 months in the combined chemotherapy group with a statistical significance of p=0.0007. 

Additionally, the median time to treatment failure in the Kisqali combined group was extended by about 10 months or more compared to 8.5 months in the combined chemotherapy group.

Comparatively, the Kisqali combined group also showed a lower incidence of severe adverse reactions.

"Kisqali has consistently improved the overall survival period in three phase 3 clinical studies, and this study also confirmed the benefits of extending the progression period in patients with advanced cancer progression,” Novartis Korea CEO Yoo Byung-jae said, “With CDK4/6 inhibitors becoming the standard treatment for patients with HR+/HER2- advanced and metastatic breast cancer, this will solidify Kisqali's position and help patients in Korea enjoy the optimal treatment."