Abemaciclib Effective for Ki67 Reduction in Certain Postmenopausal Women with Breast Cancer

Excerpt:

“Neoadjuvant abemaciclib with or without anastrozole led to significantly greater reductions in tissue Ki67 after 2 weeks of treatment than anastrozole alone among postmenopausal women with hormone receptor–positive, HER-2–negative breast cancer, according to interim phase 2 study results presented at the European Society for Medical Oncology Congress.”

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Expert Discusses Latest Data in Neoadjuvant HER2+ Breast Cancer

Excerpt:

“Results from the KRISTINE and NSABP B-41 trials presented at the 2016 ASCO Annual Meeting provided the latest data on the use of pertuzumab (Perjeta), trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), and lapatinib (Tykerb) for the neoadjuvant treatment of patients with HER2-positive breast cancer.

“In a lecture at the conference, Stephen K. Chia, MD, an assistant professor in the division of Medical Oncology at the University of British Columbia, highlighted the key findings from these trials and their implications for the treatment of HER2+ breast cancer.”

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FDA Accepts Neratinib NDA for HER2-Positive Breast Cancer

Excerpt:

“The FDA has accepted a new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin), according to a statement from the developer of the TKI, Puma Biotechnology.

“The application included findings from the phase III ExteNET study, in which neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, according to findings published in Lancet Oncology. The FDA completes a standard review within 12 months from the time of submission, which was completed for neratinib on July 21, 2016.”

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EMA Validation Puts Neratinib One Step Closer to Approval for HER2+ Breast Cancer

Excerpt:

“The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).

“The validation confirms the completion of the submission process and starts the formal review by the Committee for Medicinal Products for Human Use (CHMP) and the subsequent final approval decision by the European Commission.

“The application was based on findings from the phase III ExteNET study, which were published in the Lancet Oncology. In this study, extended treatment with neratinib demonstrated a 2-year disease-free survival (DFS) rate of 93.9% compared with 91.6% in the placebo arm, representing a 33% improvement versus placebo (HR, 0.67; P = .009).”

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Novel Findings Support Original Categorization of HER2

Excerpt:

“The original classifications of human epidermal growth factor receptor 2 (HER2) categorization by fluorescent in situ hybridization (FISH) have been supported by recent data, according to a report published online Aug. 29 in the Journal of Clinical Oncology.

“Michael F. Press, M.D., from the University of Southern California Norris Comprehensive Cancer Center in Los Angeles, and colleagues reevaluated the HER2 FISH status of patients from Breast Cancer International Research Group (BCIRG)-005/006/007 clinical trials according to current American Society of Clinical Oncology and the College of American Pathologists (ASCO-CAP) guidelines, which designate five groups based on HER2 FISH ratio and average HER2 gene copy number per tumor cell. Data were included for 10,468 patients.”

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Lead Investigator Emphasizes Impact of Equivalent Efficacy With Trastuzumab Biosimilar in HER2+ Breast Cancer

Excerpt:

“With drug prices continuing to rise, access to certain cancer treatments is becoming more challenging for patients facing financial limitations.

“Biosimilars could make it easier for some patients to afford their medications, especially those outside of the United States where these types of agents are more common, says Hope S. Rugo, MD.

“Rugo is the lead investigator on the Heritage study, which is evaluating MYL-1401O, a proposed biosimilar for trastuzumab (Herceptin), in patients with HER2-positive metastatic breast cancer.”

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Use of Anthracyclines Plus Taxanes Found to be Beneficial in Early, HER2-Negative Breast Cancer

Excerpt:

“Treatment with anthracyclines was proven to be beneficial for patients with high-risk, HER2-negative, early-stage breast cancer, according to a joint analysis of the “ABC” trials presented at the 2016 ASCO Annual Meeting.

“The analysis, which included more than 4000 patients, demonstrated that docetaxel plus cyclophosphamide (TC) was significantly inferior to various taxane-plus-anthracycline-based (TaxAC) chemotherapy regimens.

“ ‘Statistical noninferiority of the non-anthracycline regimen could not be demonstrated,’ said lead investigator Joanne Lorraine Blum, MD, PhD, medical oncologist with Texas Oncology at the Baylor-Sammons Cancer Center in Dallas. ‘In terms of the study’s primary endpoint, invasive disease-free survival, TC x 6 was significantly inferior to TaxAC.’ ”

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Updated Testing Guidelines Make More Women Eligible for Herceptin, yet Benefit Uncertain

Excerpt:

“Changes to HER2 testing guidelines for breast cancer in 2013 significantly increased the number of patients who test HER2-positive, according to a new study by Mayo Clinic researchers published in the Journal of Clinical Oncology. Cancers that have an excess of HER2 protein or extra copies of the HER2 gene are called HER2-positive and can be treated with drugs like Herceptin that target HER2. HER2 stands for human epidermal growth factor receptor 2.

“Mayo Clinic researchers found that the number of HER2-positive breast cancers doubled after testing guidelines were changed by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) in 2013. ‘The new guidelines were established to reduce the number of equivocal cases, where HER2 status is uncertain, but we found that they did just the opposite,’ says senior study author Robert Jenkins, M.D., Ph.D., the Ting Tsung and Wei Fong Chao Professor of Individualized Medicine Research and Professor of Laboratory Medicine and Pathology at Mayo Clinic. ‘The number of equivocal cases went up, resulting in additional testing and a much larger number of women with cancers ultimately labeled as HER2-positive.’ ”

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Novel Agents Emerging in Pipeline for HER2+ Breast Cancer

Excerpt:

“There have been significant advances for the treatment of HER2-positive breast cancer over the last decade, says Denise A. Yardley, MD.

“ ‘When we look at the HER2-positive patient, at this point, we have really come a long way with the initial approval of trastuzumab (Herceptin), followed by the addition of pertuzumab (Perjeta), based on the CLEOPATRA data,’ explains Yardley, senior investigator, Breast Cancer Research Program, principal investigator, Sarah Cannon Research Institute. ‘The EMILIA trial has now added T-DM1 (ado-trastuzumab emtansine; Kadcyla), a novel antibody-drug conjugate targeted against HER2.’

“While these FDA approvals have made a large impact for patients with HER2-positive breast cancer, there is still more work to be done. ‘We are really trying to extend the number of novel agents to add to the HER2-population arena,’ Yardley notes.”

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