Novartis Kisqali improves PFS in younger women
A Phase 3 trial looking at the use of Kisqali (ribociclib) to treat premenopausal or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer was found to significantly boost progression-free survival (PFS).
The trial saw Kisqali being used in combination with tamoxifen or an aromatase inhibitor, plus AZ’s Zoladex. This combination treatment was compared against the same regimen, except with a placebo standing in for Kisqali.
The findings revealed that women taking Kisqali, in combination, demonstrated a median PFS of 23.8 months. This showed a favourable profile against placebo treatment that only managed PFS of 13.0 months.
Overall response rate was found to be 51% in the Kisqali arm against 36% in the placebo group. There was also a clinically meaningful reduction in pain score after 8 weeks of treatment.
“We are pleased to see Kisqali combination therapy provide strong efficacy and prolonged quality of life with pain reduction in younger women, and look forward to working with health authorities to bring a new treatment option to premenopausal or perimenopausal women,” said Samit Hirawat, Head of Novartis Oncology Global Drug Development.
The study did not reveal whether the treatment had an impact on overall survival. However, the strong reaction in PFS is enough for Novartis to start applying for marketing authorisation for this further indication.
Should it receive the nod on this count, it would greatly expand the number of patients eligible to receive treatment.
The trial included 670 women who ranged from 23 to 58 years in age, opening up treatment eligibility beyond the post-menopausal approval it achieved just last month in by NICE.
The approval for this indication came as the first approval that NICE had made through its new process, which sees the body make its recommendation within 90 days of marketing authorisation through the European Commission.
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