Lynparza Meets Primary Endpoint in Phase III Trial in BRCA-Mutated Metastatic Breast Cancer

Excerpt:

“AstraZeneca today announced positive results from its Phase III OLYMPIAD trial comparing Lynparza (olaparib) tablets (300mg twice daily) to physician’s choice of a standard of care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline BRCA1 or BRCA2 mutations. Patients treated with Lynparza showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) compared with those who received chemotherapy (capecitabine, vinorelbine or eribulin).”

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Interim Results from Phase 1b/2 Study Evaluating the Combination of Merck’s KEYTRUDA® (pembrolizumab) and Eisai’s HALAVEN® (eribulin mesylate) Injection in Metastatic Triple-Negative Breast Cancer

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. today announced new interim data investigating Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in combination with Eisai’s microtubule dynamics inhibitor, HALAVEN® (eribulin) in patients with metastatic triple-negative breast cancer (TNBC). Findings presented during the 2016 San Antonio Breast Cancer Symposium (SABCS) were based on interim data from 39 evaluable patients and showed an overall response rate (ORR) of 33.3% (n=13/39; 95% CI, 19.5-48.1), with one complete response and 12 partial responses (Abstract #: P5-15-02). ORR was similar between PD-L1-positive and -negative cohorts [PD-L1 positive=29.4% (n=5/17; 95% CI, 11.1-51.1); PD-L1 negative=33.3% (n=6/18; 95% CI, 14.1-54.6)]. HALAVEN and KEYTRUDA are not approved for use in combination.”

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Eribulin Dose-Modification May Allow for Better Outcomes

“Women with breast cancer who received first-line treatment with the nontaxane microtubule dynamics inhibitor eribulin mesylate were able to stay on treatment longer and had better clinical outcomes when they received dose modifications during their treatment, according to the results of a poster presented at the 32nd Annual Miami Breast Cancer Conference, held February 26–March 1 in Miami Beach, Florida.

“According to the researchers, led by Joyce O’Shaughnessy, MD, of the Texas Oncology–Baylor Charles A. Sammons Cancer Center, and US Oncology, Dallas, Texas, these results suggests that ‘the use of dose modification to manage adverse events may allow patients to achieve a longer duration of eribulin therapy, which in turn may result in improved outcomes.’

“Eribulin mesylate is currently approved for the treatment of metastatic breast cancer in patients who have previously received at least two prior lines of chemotherapy, including a taxane and an anthracycline. Recently though, two phase II studies looked at eribulin as a first-line treatment and showed that the drug had clinical activity with an acceptable toxicity profile.

“The first, Study 206, included 56 patients with HER2-negative breast cancer. The second, Study 208, included 52 patients with HER2-positive disease. All patients were assigned to eribulin 1.4 mg/m2 on days 1 and 8 of a 21-day cycle. Patients enrolled in Study 208 also received trastuzumab on day 1 of each cycle.”


Eribulin Is as Good as Capecitabine in Metastatic Breast Cancer

The gist: In a recent clinical trial with locally advanced or metastatic breast cancer patients, women who took the drug eribulin did just as well as women who took capecitabine.  The results were particularly strong for women with triple-negative breast cancer. All women in the trial had received previous treatment with anthracycline- or taxane-based chemotherapy. More research is planned to determine just how beneficial eribulin might be.

“An international research team, led by Dartmouth’s Peter A. Kaufman, MD, published findings in the Journal of Clinical Oncology demonstrating that, while not superior to capecitabine, eribulin is an active and well-tolerated therapy in women with metastatic breast cancer (MBC) receiving this therapy as a first, second, or third line chemotherapy regimen. Additionally, these patients had all been previously treated with both an anthracycline and a taxane in either the adjuvant or metastatic setting. This study is the first to address the use of eribulin early in the course of metastatic breast cancer, specifically either the first or second line setting.

” ‘Additionally, it is of great interest that subset analysis suggests that eribulin may be particularly active and effective in triple negative MBC, which is known to be an aggressive subset of breast cancer, and one associated unfortunately with a particularly poor prognosis overall,’ said Kaufman.

“Eribulin has been approved in numerous countries in the third line or latter setting for the treatment of MBC, and is increasingly widely used. It is the only chemotherapeutic agent shown to have a survival benefit for patients with MBC in the third line or latter chemotherapeutic setting. Given previous research findings, and now findings from this large international trial, there has been great interest from oncologists and other clinicians in the potential impact that eribulin might have earlier in the course of MBC.”


Sea Sponge Drug Could Boost Advanced Breast Cancer Survival by Five Extra Months

“The cancer drug eribulin, originally developed from sea sponges, could give women with advanced triple negative breast cancer an average of five extra months of life, according to research presented at the National Cancer Research Institute (NCRI) Cancer Conference in Liverpool.

“Researchers led by Professor Chris Twelves, based at the University of Leeds and Leeds Teaching Hospitals NHS Trust, looked at two major clinical trials of more than 1,800 women with breast cancer that had started to spread to other parts of the body. The phase III trials – the final stage of testing before deciding whether a drug can be prescribed to patients – compared the survival of women treated with eribulin* to those given standard treatment.

“The two studies showed an overall improvement in survival of more than two months for women treated with eribulin**. The most significant improvement was seen in women with the advanced triple negative form of breast cancer, where there are limited treatment options; these women’s survival improved by nearly five months. There was also a survival boost of more than two months for women with the HER2 negative form of breast cancer***.

“Cancer spreading to other organs – called metastasis – is responsible for around 90 per cent of all cancer deaths. And, when patients with breast cancer are diagnosed after the disease has started to spread, 10-year survival is around one in 10, compared to nearly nine in 10 for those diagnosed at the earliest stage.

“Study author, Professor Chris Twelves, said: ‘Our results show a substantial improvement in survival for women with metastatic triple negative breast cancer, and a more modest, but significant, benefit for those with HER2 negative breast cancers.’

“ ‘Eribulin has previously been offered to women who’ve already been through several lines of chemotherapy. But the European Union has recently approved eribulin for patients who have received less treatment for their breast cancer, which means we hope to give more patients another treatment option in the not-too-distant future.’ “


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.”