Research from AstraZeneca and Merck & Co., Inc. (NJ, USA) has revealed that the use of Lynparza® therapy to treat women with BRCA-mutated advanced ovarian cancer results in a statistically significant delay of disease progression.
Ovarian cancer is one of the leading causes of cancer death in women, resulting in approximately 152,000 deaths worldwide in 2012. The 5-year survival rate for ovarian cancer worldwide is between 30 and 40%.
Lynparza, also known as olaparib, is a PARP inhibitor. Studies have revealed that it may work by inhibiting PARP–enzymatic activity, while increasing PARP–DNA complex formation. This means that PARP cannot carry out cell repair, and ultimately leads to death of cancer cells.
This study – a randomized, double-blind, placebo-controlled, Phase III trial known as SOLO-1 – was set up to investigate the use of Lynparza tablets as a first-line therapy for the treatment of BRCA-mutated advanced ovarian cancer. The researchers randomly selected 391 patients with a BRCA mutation to receive either Lynparza or placebo tablets twice-daily. Researchers anticipated a significant difference in the progression-free survival between the two groups.
The results from this trial demonstrated that treatment with Lynparza delivered an improvement in the progression-free survival of ovarian cancer patients. This means that the progression of the disease was significantly more delayed in patients being treated with Lynparza as opposed to the placebo.
In addition to this, the safety and tolerability profile of the drug was found to be safe, which was consistent with previous studies.
This study is the first to demonstrate that Lynparza improves progression-free survival in BRCA-mutated ovarian cancer patients. These promising results indicate that Lynparza could become a treatment option for ovarian cancer in the near future. AstraZeneca and Merck are already planning to begin talks with the relevant health authorities on regulatory submissions.
“Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza’s ability to provide meaningful disease control with a well-characterized safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the first-line maintenance setting as quickly as possible,” concluded Roy Banes, Chief Medical Officer at Merck.