AstraZeneca and Merck see positive ovarian cancer results from Lynparza

AstraZeneca, alongside Merck, announced positive results from the randomised, double-blinded, placebo-controlled, Phase III SOLO-1 trial of Lynparza (olaparib) tablets on Wednesday.

The FTSE 100 drugmaker said women with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with Lynparza maintenance therapy had a “statistically significant and clinically meaningful” improvement in progression-free survival compared to placebo.

It said the safety and tolerability profile of Lynparza was consistent with previous trials.

Based upon the data, AstraZeneca said it and Merck planned to initiate discussions with health authorities regarding regulatory submissions.

“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,” said AstraZeneca’s executive vice president of global medicines development and chief medical officer Sean Bohen.

“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.”

Roy Baynes, senior vice president and head of global clinical development, and chief medical officer at Merck’s MSD Research Laboratories, added that building on the “strong data” seen with Lynparza to date, the data from SOLO-1 reinforced its 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 regulatory authorities to bring Lynparza to women with ovarian cancer in the first-line maintenance setting as quickly as possible.”

AstraZeneca said that additionally, the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1, was testing the effect of Lynparza in combination with bevacizumab as a first-line maintenance treatment in women with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.

Results from that were expected in 2019.