Novartis steals a march in CDK4/6 market with breast cancer data

Novartis’ Kisqali has become the first drug in the CDK 4/6 inhibitor class to improve overall survival in metastatic breast cancer. The results of the MONALEESA-7 trial – reported at this year’s ASCO congress – give Novartis a leg up over other drugs in this class including Pfizer’s Ibrance (palbociclib) and Eli Lilly’s Verzenio (abemaciclib), which so far only have data indicating they can improve progression-free survival (PFS) in this form of cancer. MONALEESA-7 involved 672 premenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who were treated with either Kisqali (ribociclib) plus standard endocrine therapy or endocrine therapy alone. After 42 months of follow-up, 70% of the Kisqali-treated group were still alive, compared to 46% of the group taking endocrine therapy only – the first time that any targeted therapy has improved survival in these patients. The women who received ribociclib also lived a median of 23.8 months without the disease progressing, compared with 13 months in the control group. The results are due to be published in the New England Journal of Medicine on Tuesday. PFS results from the trial were reported in November 2017. “Advanced breast cancer in pre-menopausal women can be very aggressive,” commented Harold Burstein of Harvard Medical School and Brigham & Women's Hospital, who chairs the ASCO guidelines on endocrine therapy for breast cancer. “It is important and encouraging to see a targeted therapy that significantly increases survival for younger women with this disease,” he added. The new results are a real boost for Novartis as it plays catch-up in the market with Ibrance – which grew by a third to reach $4.1 billion in sales last year – and also tries to fend off a strong challenge from Verzenio, which has been picking up addition indications at a rapid pace and brought in $255 million in 2018. Ibrance wasn’t able to show a significant improvement in overall survival in the PALOMA-3 trial despite improvements in PFS, with a similar outcome seen in the MONARCH-2 trial of Verzenio. Kisqali was first approved in 2017 as the first-line treatment of advanced breast cancer in combination with an aromatase inhibitor in post-menopausal women with HR-positive, HER2-negative tumours. Last year, its label was extended to include pre- and perimenopausal patients, and that helped sales triple over 20917 to reach $235 million despite being overtaken by third to market Verzenio. Approval in premenopausal women would be a fillip for the brand, and add to Novartis’ armamentarium of drugs to treat HR-positive HER2-negative breast cancer now that it has picked up approval of PI3K inhibitor Piqray (alpelisib) as a second-line therapy for these patients.