Lynparza™ Clinical Trial Demonstrates Survival Benefit in Relapsed Ovarian Cancer

AstraZeneca has announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of LynparzaTM (olaparib) oral therapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer.1 Results from the trial demonstrate a clinically-meaningful improvement in survival free of cancer progression.

Importantly, the median time to cancer progression for Lynparza-treated patients substantially exceeded that observed in a previous study in patients with platinum-sensitive relapsed ovarian cancer.2

Each year in the United States, roughly 22,000 women are diagnosed with ovarian cancer and more than 15,000 die of the disease. Treatment for ovarian cancer commonly involves surgery and/or chemotherapy. Researchers continue to study new approaches for improving the outcomes of all women affected by ovarian cancer but progress has been slow.

The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy. PARP inhibitors are thought to have the greatest effect in women with mutations of the BRCA genes, who represent about 15% of ovarian-cancer patients. But recent research, still ongoing, indicates that the drugs may benefit an additional 35% of patients with different genetic profiles.

Lynparza constitutes the first PARP inhibitor approved for treating ovarian cancer. Lynparza was approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.1

The FDA approved Lynparza3 with a genetic test called BRACAnalysis CDx, a companion diagnostic that will detect the presence of mutations in the BRCA genes (gBRCAm) in blood samples from patients with ovarian cancer. The BRCA genes are involved with repairing damaged DNA and normally work to suppress tumor growth. Women with mutations resulting in defective BRCA genes are more likely to get ovarian cancer, and it is estimated that 10 to 15 percent of all ovarian cancer is associated with these hereditary BRCA.

References

  1. National Institutes of Health. Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy. Available at: http://clinicaltrials.gov/show/NCT01874353. Last accessed October 2016.
  2. Ledermann J, Harter P, Gourley C, et al. Overall survival in patients with platinum-sensitive recurrent serous ovarian cancer receiving olaparib maintenance monotherapy: an updated analysis from a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Oncol. 2016; S1470-2045(16)3037 1-12
  3. FDA Approval Letter. U.S. Food and Drug Administration, Silver Spring, MD. Available Online. Accessed July, 2016.

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