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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BRCA2 Mutations Herald Poor Prognosis in Screen-Detected Prostate Cancer

Editor’s note: You may have heard about the BRCA2 mutation, which can increase a person’s risk for breast cancer. Studies have also shown that it can increase a man’s risk of prostate cancer. Studies have also shown that prostate cancer patients with BRCA2 mutations generally do not survive as long as prostate cancer patients without BRCA2 mutations. A new study explored this more in depth by looking at survival rates for BRCA2+ men who were diagnosed with prostate cancer after standard screening. These men did indeed have shorter survival times than prostate cancer patients without BRCA2 mutations. The researchers say these patients might “benefit from additional therapies, such as with cis-platinum or a PARP [poly ADP-ribose polymerase] inhibitor.”

“Among men with prostate cancer detected on screening, survival among those with a mutation in the BRCA2 gene is much poorer than in those without such a mutation, researchers report.

“The findings suggest that BRCA2 mutation carriers may warrant additional treatments to improve their prognosis, say Steven Narod (Women’s College Hospital, Toronto, Ontario) and fellow authors writing in the British Journal of Cancer.

“BRCA2 mutations are known to confer an increased risk for developing prostate cancer and also to be associated with more aggressive tumours. However, the effect of BRCA2 mutations status on mortality in the setting of screen-detected cancers is unclear.”


Sarah Cannon Research UK and BioMarin Collaborate on EMBRACA Clinical Study in Hereditary Breast Cancer With BRCA Mutation

The gist: Researchers are conducting a clinical trial with volunteer patients to test a new breast cancer treatment called BMN673. BMN673 is a “PARP inhibitor” drug that may benefit patients who have hereditary mutations in the BRCA genes. Patients involved in the trial must have locally advanced and/or metastatic breast cancer, and must have undergone no more than two prior chemotherapy treatments for metastatic disease.

” ‘We are excited to collaborate with BioMarin on this landmark trial to increase the treatment opportunities for patients with BRCA related breast cancer,’ said Dr Alison Jones, Consultant Medical Oncologist and Principal Investigator for the EMBRACA Phase 3 trial at Sarah Cannon Research Institute UK.

” ‘This study is an important milestone for both organizations to foster future collaborations,’ highlighted Dr Hendrik-Tobias Arkenau, FRCP, PhD, Medical Oncologist and Medical Director at Sarah Cannon Research Institute UK.

” ‘Sarah Cannon Research UK has a long history of pioneering significant advances in medical therapy, and we are thrilled to commence enrollment outside of the United States to evaluate the safety and efficacy of BMN 673 in patients with hereditary breast cancer,’ said Hank Fuchs, M.D., Chief Medical Officer of BioMarin. ‘Breast cancer patients with germline BRCA-associated tumors have no targeted treatment options. There is an unmet need for therapies that target specific molecular defects in tumors, and PARP inhibitors offer that potential in BRCA-related breast cancer.’

“The EMBRACA Phse 3 study began in the United states in the fall of 2013 and has expanded internationally. BioMarin plans to enroll patients from sites around the world and to work with partners outside of the United States. The EMBRACA Phase 3 study is an open-label, randomized, parallel, two-arm, multi-center study of BMN 673 versus physician’s choice in approximately 430 germline BRCA mutation patients with locally advanced and/or metastatic breast cancer, who have received no more than two prior chemotherapy regimens for metastatic disease. The primary objective of the study is to measure progression free survival (PFS). Secondary objectives include evaluating the objective response rate (ORR) and the overall survival (OS).”


Olaparib Maintenance for Ovarian Cancer Most Effective in Women with BRCA Mutations

Editor’s note: After initial treatment, some cancer patients receive maintenance therapy to keep their cancer from returning. In a recent clinical trial with volunteer patients, scientists tested the effectiveness of maintenance therapy for platinum-sensitive recurrent serous ovarian cancer. Some of the women had BRCA1 or BRCA2 mutations, and some did not. Also, all of the women had previously been treated with platinum-based chemotherapy, and experienced tumor shrinkage or complete disappearance of their tumors. In the clinical trial, scientists randomly divided the women into two groups. One group received maintenance therapy with the drug olaparib, and for comparison, the other group was treated with a “fake” placebo drug. The scientists found that women with BRCA1 or BRCA2 mutations were more likely to benefit from the maintenance therapy treatment than women without BRCA mutations.

“Women with platinum-sensitive recurrent serous ovarian cancer who harbored BRCA mutations are more likely than BRCA wild-type patients to benefit from maintenance monotherapy with olaparib, results of a phase 2 study suggest.

“ ‘To our knowledge, our study is the first phase 2 trial in ovarian cancer to show that patients with BRCA1 or BRCA2 mutations respond preferentially to a PARP inhibitor,’ Jonathan Ledermann, MD, of UCL Cancer Institute at University College London, and colleagues wrote.

“Ledermann and colleagues conducted a randomized, double blind study that included 265 women with platinum-sensitive recurrent serous ovarian cancer. All patients received at least two platinum-based regimens and demonstrated a complete or partial response to their most recent platinum-based regimen.”