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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CDK4/6 Inhibitor Shows Promise as Single Agent in HR+ Breast Cancer

Excerpt:

“As a single agent, abemaciclib has shown exciting potential in heavily pretreated patients with refractory, hormone-receptor (HR)–positive, HER2-negative advanced breast cancer, following phase II findings of the MONARCH 1 trial.

“Results of the single-arm study, which were presented during the 2016 ASCO Annual Meeting1, show that the CDK4/6 inhibitor induced a response rate of nearly 20% in this patient population. The median progression-free survival (PFS) was 6 months (95% CI 4.2-7.5) and the median overall survival (OS) was 17.7 months (95% CI, 16 to not reached). Previously, abemaciclib received a breakthrough therapy designation in this setting from the FDA in October 2015.”

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Puma Biotechnology Submits Marketing Authorization Application for PB272 (Neratinib) as Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer in Europe

Excerpt:

“Puma Biotechnology, Inc. (NYSE: PBYI), a biopharmaceutical company, announced that it has submitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for neratinib. The potential indication is for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with trastuzumab (Herceptin®)-based adjuvant therapy. The submission is based upon the ExteNET Phase III study, which reached its primary endpoint whereby neratinib demonstrated a statistically significant reduction of risk of invasive disease recurrence or death versus placebo.”

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Neoadjuvant HER2+ Breast Cancer Options Need Refinement, Expert Says

Excerpt:

“While recent findings from the I-SPY 2 trial have shown potential with the combination of ado-trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) for patients with HER2-positive breast cancer, the neoadjuvant space still has a lot of work ahead, according to Lisa A. Carey, MD.

“Results presented at the 2016 AACR Annual Meeting1 showed that, out of the 249 patients enrolled on the I-SPY 2 study, 54% of those who received T-DM1/pertuzumab experienced a pathological complete response (pCR) rate compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“This suggests that T-DM1 could increase overall survival (OS) in this patient population, but Carey adds more research with the regimen needs to be conducted.”

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Comparing Combination Treatments in HER2-Positive Early Breast Cancer

Excerpt:

“In patients with HER2-positive early breast cancer, data from a phase III trial has shown a significantly higher pathological complete response (pCR) rate with neoadjuvant docetaxel plus carboplatin plus trastuzumab plus pertuzumab (TCH+P) versus trastuzumab emtansine plus pertuzumab (T-DM1+P).

“According to the results of the KRISTINE trial, the TCH+P regimen was also associated with a higher rate of breast conserving surgery. However, researchers reported that T-DM1+P had a notably better safety profile and that health-related quality of life and physical functioning were maintained longer.

“ ‘Neoadjuvant TCH+P achieved a superior pCR rate compared with T-DM1+P and was associated with a higher breast-conserving-surgery rate,’ said Sara A. Hurvitz, MD, General Internal Medicine, Hematology & Oncology, UCLA Medical Center in Santa Monica, CA. ‘However, neoadjuvant T-DM1+P had a more favorable safety profile, with lower incidence of grade 3 or greater adverse events, serious adverse events, and adverse events leading to treatment discontinuation.’ ”

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Lilly Announces Results from MONARCH 1 Trial of Abemaciclib Monotherapy

Excerpt:

“Eli Lilly and Company (LLY) today announced results from the MONARCH 1 Phase 2 study of abemaciclib, a cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor, in patients with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. The data, which were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting by Maura Dickler, M.D., of Memorial Sloan Kettering Cancer Center, showed that single-agent activity was observed in metastatic breast cancer patients, for whom endocrine therapy was no longer a suitable treatment option. The MONARCH 1 results (abstract #510) confirmed objective response (ORR), durability of response (DoR), clinical benefit rate (CBR) and progression-free survival (PFS).

“The single-arm study, designed to evaluate the safety and efficacy of abemaciclib monotherapy, enrolled 132 patients who were given 200 mg of abemaciclib orally every 12 hours until disease progression. Patients enrolled in the study were heavily pretreated, having experienced progressive disease on or after prior endocrine therapy, and had received prior chemotherapy with one or two chemotherapy regimens for metastatic disease. The primary objective of the trial was investigator-assessed ORR, with secondary endpoints of DoR, CBR and PFS.”

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