Eribulin Plus Trastuzumab Safe, Effective in HER-2–Positive Metastatic Breast Cancer

The gist: Researchers recently tested a breast cancer treatment in a clinical trial—a research study with volunteer patients. The treatment combines the drug trastuzumab (aka Herceptin) with a new drug called eribulin mesylate. The goal of the trial was to find out how well the combination might work for patients who had already been treated with trastuzumab. All patients who participated had HER-positive metastatic breast cancer. It was found that the treatment was safe and effective, regardless of whether patients had already taken trastuzumab.

“Eribulin mesylate plus trastuzumab demonstrated activity in patients with HER-2–positive metastatic breast cancer regardless of prior treatment with trastuzumab, according to phase 2 study results presented at the Breast Cancer Symposium.

“Joyce O’Shaughnessy, MD, of the Texas Oncology Baylor Charles A. Sammons Cancer Center, and colleagues sought to evaluate whether prior trastuzumab (Herceptin, Genentech) affected the efficacy of eribulin mesylate (Halaven, Eisai) plus trastuzumab. Previous data indicated the combination conferred a 71% objective response rate as a first-line treatment.

“The analysis included 52 patients (median age, 59.5 years) who had not undergone prior chemotherapy for metastatic breast cancer. Twenty-one patients had previously received trastuzumab and 31 had not. A median of 23 months had passed since previous treatment.

“Patients received 1.4 mg/m2 IV eribulin mesylate on days 1 and 8 of a 21-day cycle. They also received an initial trastuzumab dose of 8 mg/kg, followed by 6-mg/kg doses on day 1 of each cycle. Median treatment duration was approximately 30 weeks.

“Researchers reported similar rates of objective clinical response (62% vs. 77%) and clinical benefit (81% vs. 87%) between patients who had received prior trastuzumab and those who had not.”


Eisai Announces Top-Line Phase III Trial Results of Eribulin in Patients with Advanced Non-Small Cell Lung Cancer Following at Least Two Prior Regimens

Editor’s note: Researchers conducted a clinical trial with volunteer patients to test whether anticancer drug eribulen (brand name Halaven) might help treat people with advanced non-small cell lung cancer that has worsened despite two or more treatment attempts. Some of the patients enrolled in the trial were treated with eribulen and, for comparison, the rest received standard treatments. Unfortunately, the patients who were treated with eribulen did not survive significantly longer than the patients who received standard treatments, so at this time, it does not appear to be a good alternative for these types of patients.

“Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, ‘Eisai’) announced today top-line results of the investigational Phase III study (Study 302) of its in-house developed anticancer agent eribulin mesylate (‘eribulin,’ Brand name: Halaven®) in patients with advanced non-small cell lung cancer (NSCLC) that has progressed following two or more prior treatment regimens.

“Study 302 was a global, multicenter, randomized, open-label Phase III trial comparing the efficacy and safety of eribulin with a single treatment of physician’s choice (TPC) consisting of either docetaxel, pemetrexed, gemcitabine or vinorelbine in 540 patients with advanced NSCLC and disease progression following at least two prior regimens for advanced disease, which included a platinum-based regimen.

“The preliminary analysis of the study showed that Study 302 did not meet its primary endpoint of improving overall survival (OS); the median OS in both arms was 9.5 months (Hazard Ratio 1.16; p=0.1343). The preliminary safety analysis showed that the most common adverse reactions in the eribulin arm were decreased appetite, neutropenia, alopecia, nausea and fatigue, which were consistent with the known side-effect profile of eribulin.”