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Abemaciclib regimen extends PFS among certain women with advanced breast cancer

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The combination of abemaciclib plus an aromatase inhibitor significantly extended PFS among women with hormone receptor–positive, HER-2–negative advanced breast cancer, according to an interim analysis of a phase 3 study.

The global, double blind, placebo-controlled MONARCH 3 trial evaluated the safety and efficacy of abemaciclib (LY2835219, Eli Lilly), a CDK4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with advanced breast cancer.

Researchers randomly assigned 493 patients to 150 mg abemaciclib or placebo twice daily without interruption, in combination with 1 mg anastrozole (Arimidex, AstraZeneca) or 2.5 mg letrozole (Femara, Novartis) once daily. Treatment continued until disease progression or unacceptable toxicity.

PFS served as the primary endpoint. Secondary endpoints included objective response rate, OS and safety.

Patients assigned the abemaciclib regimen achieved superior PFS. Researchers also reported a higher ORR in the abemaciclib group.

The most common adverse events included diarrhea, neutropenia, fatigue and nausea.

“Today marks another important milestone in our clinical development program for abemaciclib, a drug we believe has the potential to be best in class,” Levi Garraway, MD, PhD, senior vice president of global development and medical affairs at Lilly Oncology, said in a company-issued press release. “These data underscore Lilly's commitment to delivering life-changing medicines to treat and cure people living with cancer around the world.”

Additional studies of abemaciclib are ongoing. They include:

• the monarcHER study, designed to evaluate abemaciclib plus trastuzumab (Herceptin, Genentech) in women with hormone receptor–positive, HER-2–positive locally advanced or metastatic breast cancer; and
• the phase 3 MONARCH plus study, designed to evaluate abemaciclib in combination with endocrine therapies to support registration in China.

The drug also is being evaluated for the treatment of patients with lung cancer, pancreatic cancer and brain metastases.