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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Chemotherapy May Not Be Necessary for Intermediate-Risk, Early-Stage Breast Cancer

Excerpt:

“Women with early-stage breast cancer and an intermediate risk recurrence score from a 21-gene expression assay may be able to avoid chemotherapy, according to a retrospective study published in Cancer.

” ‘Through years of research discoveries, it became clear that we were overtreating many women with breast cancer, especially those with early-stage breast cancer,’ Carlos H. Barcenas, MD, assistant professor of breast medical oncology at The University of Texas MD Anderson Cancer Center, said in a press release. ‘In addition to chemotherapy’s obvious side effects, there were also long-term complications for these women as survivors.’ ”

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Chemo Benefit Unclear in Breast Cancer Patients With Higher Recurrence Scores

Excerpt:

“In patients with hormone receptor–positive, HER2-negative, lymph node–negative breast cancer with a recurrence score (RS) based on a 21-gene expression assay of 11 to 25, outcomes were similar whether chemotherapy was used or not used, according to a retrospective analysis. However, the study’s limited follow-up means a benefit from chemotherapy in these patients cannot be ruled out.

“The Oncotype DX 21-gene expression assay is the most commonly used test of this kind in breast cancer in the United States. It offers an RS, and previous research has shown that patients with an RS below 11 fare very well when treated with endocrine therapy alone. ‘To our knowledge, it is unknown whether chemotherapy provides any additional benefit in outcomes in patients with hormone receptor–positive, HER2-negative, lymph node–negative, early-stage breast cancer with an RS of 11 to 25 who are treated with endocrine therapy,’ wrote study authors led by Carlos H. Barcenas, MD, MSc, of the University of Texas MD Anderson Cancer Center in Houston.”

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Fulvestrant Prolongs PFS for Women with Hormone Receptor– Positive Advanced Breast Cancer

Excerpt:

“Fulvestrant prolonged PFS compared with anastrozole among women with hormone receptor– positive locally advanced or metastatic breast cancer who have not received previous endocrine therapy, according to a phase 3, randomized, double blind trial published in The Lancet.

” ‘The primary endpoint of this phase 3 study was met, with patients receiving fulvestrant having a significantly longer PFS than patients receiving anastrozole,’ John F.R. Robertson, MD, a professor at University of Nottingham Medical School and Royal Derby Hospital Centre in Derby, United Kingdom, and colleagues wrote. ‘This represents a meaningful and relevant finding for which clinical data are limited.’ ”

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Continuous Low-Dose Ribociclib Active in Advanced Breast Cancer Causes Less Neutropenia

Excerpt:

“Continuous low-dose ribociclib shows preliminary activity, and has an acceptable safety profile as an alternative to intermittent ribociclib dosing when combined with fulvestrant in the treatment of postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer.

“A phase Ib study, presented at the 2016 San Antonio Breast Cancer Symposium, demonstrated a confirmed partial response (PR) of 13.3% in the continuous ribociclib arm, compared with 23.1% in the intermittent ribociclib arm, but a lower rate of high-grade neutropenia in patients receiving continuous dosing of ribociclib.”

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Three-Drug Breast Cancer Regimen Slows Progression

Excerpt:

“Adding a drug to a standard regimen for hormone receptor (HR)-positive and HER2-positive breast cancer improved progression-free survival, a researcher said here.

“In a Phase II randomized trial, investigators compared an aromatase inhibitor (AI) combined with pertuzumab (Perjeta) and trastuzumab (Herceptin) versus an AI just with trastuzumab in women with locally advanced or metastatic breast cancer, Grazia Arpino, MD, PhD, of the University of Naples Federico II in Italy, reported at a general session at the San Antonio Breast Cancer Symposium.

“The three-drug combination led to a median of 18.89 months without progression, compared with 15.8 months for the two drugs.”

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Neoadjuvant Abemaciclib Active in HR+/HER2- Breast Cancer

Excerpt:

“A neoadjuvant regimen combining the CDK4/6 inhibitor abemaciclib with anastrozole induced a response rate of 54.7% in patients with HR+/HER2-negative early-stage breast cancer, according to findings from the phase II neoMONARCH trial presented at the 2016 San Antonio Breast Cancer Symposium.

“The study also met its primary endpoint of reduction in Ki67 expression level at week 2. The abemaciclib combination yielded a geometric mean change in Ki67 from baseline to day 15 of -92.6%.”

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Adding Everolimus to Fulvestrant Improved Outcomes for Postmenopausal Patients With HR-positive Breast Cancer

Excerpt:

“Progression-free survival was more than doubled for patients with metastatic hormone receptor (HR)-positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data from the PrECOG 0102 phase II clinical trial presented at the 2016 San Antonio Breast Cancer Symposium, held Dec. 6–10.

” ‘Endocrine therapy, often with an aromatase inhibitor, is the standard of care for most patients with HR-positive advanced breast cancer,’ said Noah S. Kornblum, MD, assistant professor of medicine at Albert Einstein College of Medicine and attending physician, medicine at Montefiore Einstein Center for Cancer Care. ‘However, over time, resistance to aromatase inhibitors develops and treating patients with aromatase inhibitor–resistant disease remains a challenge.’ ”

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