Lilly said a combination therapy of Verzenio and fulvestrant significantly prolonged the median survival rate in women with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer previously treated with endocrine therapy.
|Lilly’s metastatic breast cancer treatment Verzenio|
The median survival of the combination therapy was 46.7 months compared to the 37.3 months median survival of placebo plus fulvestrant.
The company presented the results as a late-breaking abstract in the Presidential Symposium at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, on Friday, and simultaneously published it in JAMA Oncology.
Results from the Phase 3 MONARCH 2 clinical trial, which involved both premenopausal and postmenopausal women, were consistent across subgroups.
In women previously treated with endocrine therapy whose cancer quickly returned or spread to other parts of the body, called primary endocrine resistance, the results were consistent with the intent-to-treat (ITT) group. The company observed similar results in women whose breast cancer spread to other organs, such as the liver or lungs.
In addition to extending life, an exploratory analysis of these data has shown Verzenio in combination with fulvestrant delayed the time to chemotherapy, with a median time to chemotherapy of 50.2 months versus 22.1 months in the placebo arm.
In this exploratory analysis, women who died before receiving chemotherapy were included up until the date of death.
The safety profile was consistent with that of the primary analysis of MONARCH 2. No new safety signals were observed with long term follow-up. At the time of analysis, 17 percent of patients in the Verzenio group remained on treatment versus 4 percent in the placebo group.
"It has been a major challenge in our field to extend survival, our ultimate goal, with current therapies for HR+, HER2- advanced breast cancer," said Maura Dickler, vice president for late-stage development at Lilly Oncology. "We are excited that Verzenio, in combination with fulvestrant, has demonstrated the ability to improve overall survival."
These are clinically meaningful results that confirm Verzenio can keep advanced breast cancer from progressing and can extend life, Dickler added.
Lilly said it would continue to monitor patients enrolled in the trial and plans to submit these overall survival data to global regulatory authorities. Verzenio, in combination with fulvestrant, is currently approved in more than 50 countries worldwide.