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2018-12-28| R&DTrials & Approvals

First PARP inhibitor approved for 1L maintenance therapy of BRCAm advanced ovarian cancer

by GeneOnline
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By Ajay V. Patil

US FDA approved Lynparza®Olaparib for the maintenance treatment of adult patients with deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.

Ovarian Cancer

Ovarian cancer has a five-year survival rate of 19% worldwide. In this year, 295,000 new cases and about 185,000 deaths are correlated with ovarian cancer. For newly diagnosed patients the overall survival at 5 years has slightly improved during the last 20 years. The two most important factors for the lack of improvement are a high rate of advanced disease at diagnosis and lack of new therapeutic options.

Phase III clinical trial

Significant improvement in objective response rate (ORR) – the primary endpoint of the trial along with improved secondary endpoint of progression-free survival (PFS) in comparison to chemotherapy are key highlights of the trial. Safety and tolerability of olaparib was found similar to earlier studies. It is first phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer. These results from Olaparib are crucial for relapsed patients with gBRCAm advanced ovarian cancer following multiple lines of chemotherapy.

We have covered initial development of Olaparib in collaboration by Astrazeneca and Merck & Co. in our previous article (PARP inhibitors in cancer – BRCA or no BRCA).

Besides this recent approval for ovarian cancer, Olaparib is already approved for gBRCAm HER2-negative metastatic breast cancer patients who have previously been treated with chemotherapy.

Companion diagnostics

Along with this approval of Olaparib, US FDA also approved companion diagnostic test from Myriad Gnetics Inc. – BRACAnalysis CDx®, to identify patients with advanced ovarian cancer who have a germline BRCA mutation (gBRCAm). Assay analyses variants of protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes. Lloyd Sanders, president, Myriad Oncology explained, “We estimate there are more than 20,000 patients newly diagnosed with ovarian cancer in the United States every year who qualify for a BRACAnalysis CDx test.”

Astrazeneca and Merck & Co. strategic collaboration

In July 2017, AstraZeneca and Merck & Co., announced a global strategic oncology collaboration to co-develop and co-commercialise olaparib (PARP inhibitor) and selumetinib (MEK inhibitor), for multiple cancer types. The companies will be independently developing Lynparza and selumetinib in combination with their respective PD-1 and PD-L1 medicines as well.

References

  1. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2018/lynparza-meets-primary-endpoint-in-phase-iii-solo-3-trial-for-the-treatment-of-relapsed-brca-mutated-advanced-ovarian-cancer20122018.html
  2. https://globenewswire.com/news-release/2018/12/19/1669803/0/en/BRACAnalysis-CDx-Approved-by-U-S-Food-and-Drug-Administration-as-Companion-Diagnostic-for-AstraZeneca-s-Lynparza-olaparib-in-Patients-with-Advanced-Stage-BRCA-Mutated-Ovarian-Cance.html
  3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5524247/
  4. https://globenewswire.com/news-release/2018/12/19/1669803/0/en/BRACAnalysis-CDx-Approved-by-U-S-Food-and-Drug-Administration-as-Companion-Diagnostic-for-AstraZeneca-s-Lynparza-olaparib-in-Patients-with-Advanced-Stage-BRCA-Mutated-Ovarian-Cance.html
  5. https://www.geneonline.com/2018/07/03/parp-inhibitors-in-cancer-brca-or-no-brca/?doing_wp_cron=1545791980.8506059646606445312500

 

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