ESMO studies show CD4K/6 inhibitor and fulvestrant improves OS in breast cancer

pharmafile | October 1, 2019 | News story | Manufacturing and Production  

Detailed findings from two Phase III trials presented at the European Society for Medical Oncology showed that treatment with a CDK4/6 inhibitor plus fulvestrant improved overall survival in women with advanced breast cancer versus fulvestrant and placebo.

The 726-patient MONALEESA-3 study used patients with HR+/HER2- advanced breast cancer and investigated Novartis’ Kisquali (ribociclib) as a first or second-line treatment in postmenopausal women, while MONARCH 2 evaluated Eli Lilly’s Verzenio (abemaciclib) in 669 patients, regardless of menopausal state, after failure of endocrine therapy.

An ESMO statement said: “The results give the treating physician the full spectrum of choice of CDK4/6 inhibitor for each individual patient, although the two CDK4/6 inhibitors have slightly different management requirements and toxicity profiles.”

Novartis previously noted that MONALEESA-3 had met its primary endpoint with combo therapy Kisquali plus fulvestrant significantly improving progress-free survival (PFS) in HR+/HER2- advanced breast cancer.

Kisqali achieved $235 million in sales in 2018, well behind $4.1 billion for Pfizer’s first-to-market CDK4/6 inhibitor Ibrance (palbociclib) even though the latter failed to significantly extend survival in breast cancer patients in another late stage trial. Analysts currently estimate that by 2024, Kisqali will generate sales of roughly $1.2 billion per year by 2024.

In the MONARCH 2 trial, Eli Lilly stated Verzenio plus fulvestrant significantly extended life by a median of 9.4 months compared with placebo plus fulvestrant. The company previously reported that the combo improved PFS versus fulvestrant alone meaning the latest findings are consistent with the original ones.

Additional analyses reveal that Vernezio plus fulvestrant delayed the time to chemotherapy, with a median time to chemotherapy of 50.2 months versus 22.1 months for placebo.

George Sledge, first author of MONARCH 2, suggested “the main take-home message from this study – and from other similar studies – is that CDK4/6 inhibitors significantly prolong the time patients remain in remission and significantly improve overall survival.

“Therefore it is very reasonable to think of these as standard-of-care options for patients with metastic breast cancer.”

Nik Kiran

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