Adding Abemaciclib Offers Good Outcomes in Pre-/Perimenopausal Breast Cancer

Excerpt:

“The addition of the CDK4/6 inhibitor abemaciclib to fulvestrant significantly improved progression-free survival (PFS) and time to subsequent chemotherapy in pre- and perimenopausal women with hormone receptor–positive/HER2-negative advanced breast cancer, according to results from an analysis of the phase III MONARCH-2 trial (abstract 1002) presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 1–5 in Chicago.”

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Lilly Breast Cancer Treatment Lands Another Approval

Excerpt:

“The U.S. Food and Drug Administration has given another approval for a breast cancer treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The announcement marks the third FDA approval for Verzenio in five months.

“The most recent ruling approves Verzenio, also known as abemaciclib, for use in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of postmenopausal women with advanced or metastatic breast cancer. Lilly says the approval follows the results of a successful Phase 3 clinical trial.”

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Abemaciclib/Pembrolizumab Combo Shows Early Promise for HR+/HER2- Breast Cancer

Excerpt:

“The combination of abemaciclib (Verzenio) and pembrolizumab (Keytruda) showed preliminary signs of activity without additive toxicity for patients with pretreated HR-positive, HER2-negative metastatic breast cancer, according to early results from a pilot trial presented in a poster at the 2017 San Antonio Breast Cancer Symposium (SABCS).

“At a 16-week analysis, the objective response rate (ORR) with the combination was 14.3%, which was less than the response rate seen with single-agent abemaciclib in the MONARCH-1 trial (19.7%). However, the trial investigators noted that the median time to response for abemaciclib has historically been 3.7 months, suggesting the efficacy is likely to improve with longer follow-up. At 16 weeks, the ORR in the MONARCH-1 trial was 6.8%.”

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EU, US Approvals for Faslodex Combinations

Excerpt:

“AstraZeneca’s Faslodex has been cleared on both sides of the Atlantic for use in combination with a CDK4/6 inhibitor.

“In the EU, the drug’s use has been approved for use alongside the CDK4/6 inhibitor palbociclib to treat a certain form of breast cancer, in the US it can be prescribed in combination with the CDK4/6 inhibitor abemaciclib.

“Both the European Commission and US Food and Drug Administration have approved the combination for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.”

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FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

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FDA Approves Verzenio for Hormone Receptor-Positive, HER-2-Negative Breast Cancer

Excerpt:

“The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.”

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ESMO: Lilly Breast Cancer Drug Keeps Pace With Pfizer, Novartis Rivals

Excerpt:

“Eli Lilly and Co.’s experimental breast cancer drug abemaciclib significantly cut the risk of disease progression in a late-stage trial, bolstering the drug’s potential to become a new source of growth for the Indianapolis pharma’s oncology business.

“Updated results from a late-stage study known as MONARCH 3, presented over the weekend at the European Society of Medical Oncology’s annual meeting, showed abemaciclib in combination with an aromatase inhibitor extended progression-free survival in previously untreated patients with metastatic breast cancer.

“Eli Lilly has previously said abemaciclib could be best in class, yet it’s not clear whether the data disclosed to date will be enough to outshine rival drugs already marketed by Pfizer Inc. and Novartis AG.”

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Expert Discusses Abemaciclib Potential in HR+/HER2- Breast Cancer Patients With Brain Mets

Excerpt:

“Abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, preliminary evidence suggests.

“Results were presented in a poster at the 2017 ASCO Annual Meeting for 23 patients from a stage 1 efficacy analysis from a phase II study.

” ‘What we found were 2 patients who experienced partial responses within the CNS, suggesting there is activity of the agent in the brain and in patients who have HR-positive disease,’ explained lead author Sara M. Tolaney, MD, MPH.”

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Abemaciclib Active in HR+/HER2- Breast Cancer Patients With Brain Mets

Excerpt:

“Preliminary evidence suggests that abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.

“Results were presented in a poster at the 2017 ASCO Annual Meeting for 23 patients from a stage 1 efficacy analysis from a phase II study.

” ‘What we found were 2 patients who experienced partial responses within the CNS, suggesting there is activity of the agent in the brain and in patients who have HR-positive disease,’ explained lead author Sara M. Tolaney, MD, MPH.”

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