In September 2017, the FDA (US Food and Drug Administration) approved Eli Lilly’s (LLY) Verzenio-fulvestrant combination therapy for the treatment of women with hormone receptor-positive or HR+ and human epidermal growth factor 2 negative or HER2- metastatic breast cancer whose disease has progressed after endocrine therapy.
The FDA has also approved Verzenio as a monotherapy for the treatment of adult individuals with HR+ and HER2- advanced or metastatic breast cancer whose disease has progressed after endocrine therapy and chemotherapy in the metastatic setting.
Verzenio (abemaciclib) is the first and only U.S. FDA approved CDK (Cyclin-dependent kinase) 4 & 6 inhibitor in combination with fulvestrant and as monotherapy. AstraZeneca (AZN) manufactures and commercializes Faslodex (fulvestrant).
The US approval of Verzenio was based on the results of the phase-3 Monarch 2 trial and the phase-2 Monarch 1 trial. In the phase-3 Monarch 2 trial, the Verzenio-fulvestrant combination therapy demonstrated a 16-month median PFS (progression-free survival) in patients who showed progression after prior endocrine therapy. Patents on Verzenio-fulvestrant demonstrated median PFS of 16.4 months, compared with 9.3 months for patients on placebo and fulvestrant.
In the phase-3 Monarch 2 trial, 48.1% of the patients on Verzenio-fulvestrant achieved ORR (objective response rate), compared with 21.3% of patients on placebo and fulvestrant. In the Monarch 2 trial, 44.7% patients achieved a partial response, and 3.5% of the patients achieved a complete response. (Partial response refers to a reduction in 30% of target lesions.)
Eli Lilly has made Verzonia available in 50 mg, 100 mg, 150 mg, and 200 mg tablets. Verzenio will compete with Novartis’ (NVS) Kisqali and Pfizer’s (PFE) Ibrance. Notably, the SPDR S&P 500 ETF (SPY) has ~0.38% of its total portfolio holdings in LLY.