AstraZeneca’s Lynparza proves efficacy in first-line BRCA-mutated advanced ovarian cancer

pharmafile | June 27, 2018 | News story | Research and Development, Sales and Marketing AstraZeneca, Cancer, MSD, Merck, ovarian cancer, pharma 

AstraZeneca is celebrating alongside partner MSD with the reveal of new data on the use of Lynparza in the first-line treatment of BRCA-mutated advanced ovarian cancer, showing that the poly (ADP-ribose) polymerase (PARP) inhibitor met its primary endpoint and “significantly delays” disease progression – the first such drug to do so.

Lynparza was shown to produce “statistically significant and clinically meaningful improvement” in progression-free survival compared to placebo in treatment of the disease, while its safety profile was shown to be consistent with previous findings.

On the back of this data, AZ and MSD announced that they plan to strike up discourse with regulatory authorities in order to pursue marketing authorisation. Lynparza is already approved as a viable treatment for use in patients with BRCA mutations, but only as an option after other treatments have failed; an approval as a first-line treatment could increase the number of eligible, newly diagnosed patients for the drug by 30-50%, according to the manufacturer.  

“For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor,” remarked Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “The SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”

Dr Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer at Merck Research Laboratories, commented: “Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforce Lynparza’s ability to provide meaningful disease control with a well-characterised safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with the regulatory authorities to bring Lynparza to women with ovarian cancer in the first-line maintenance setting as quickly as possible.”

Matt Fellows

Related Content

Merck invests €35m in biosafety testing in Scotland

Merck has announced that it has invested €35m in biosafety testing at its sites in …


AstraZeneca’s Ultomiris approved in Japan for prevention of relapses in patients with NMOSD

AstraZeneca has announced that Ultomiris (ravulizumab) has been approved in Japan as a long-acting C5 …


AstraZeneca shares oncology data at ASCO 2023

AstraZeneca plans to share data from its oncology pipeline at the American Society of Clinical …

Latest content