AstraZeneca's Lynparza puts kibosh on ovarian cancer in SOLO-1 trial

AstraZeneca, along with its partner Merck & Co, announced detailed results from the Phase III SOLO-1 trial testing ‘Lynparza’ (olaparib) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy.

The FTSE 100 drugmaker said the results of the trial confirmed the “statistically-significant and clinically-meaningful” improvement in progression-free survival for Lynparza compared to placebo, reducing the risk of disease progression or death by 70%.

At 41 months of follow-up, it said the the median progression-free survival for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo.

Of those receiving Lynparza, 60% remained progression-free at 36 months compared to 27% of women in the placebo arm.

“There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70% of women relapse within the first three years after their initial treatment,” said AstraZeneca’s executive vice-president of global medicines development and chief medical officer Sean Bohen.

“The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly-diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparza as a maintenance therapy in the first-line setting.”

Roy Baynes, senior vice-president and head of global clinical development, and chief medical officer at Merck’s MSD Research Laboratories, added that the collective goal of the two firms in oncology research was to improve long-term outcomes for people living with cancer.

“Based on the SOLO-1 trial results, Lynparza is the only PARP inhibitor to have demonstrated a significant and clinically-meaningful improvement in reducing the risk of progression for newly-diagnosed patients with advanced BRCA-mutated ovarian cancer following platinum-based chemotherapy.

“We are working with regulatory authorities as quickly as possible to seek approval of Lynparza for these patients.”

Kathleen Moore, co-principal investigator of the SOLO-1 trial and associate director for clinical research at the Stephenson Cancer Center at the University of Oklahoma, explained that women with ovarian cancer were often diagnosed with advanced disease, which was associated with poor long-term survival rates.

“The newly-diagnosed setting is our best opportunity to achieve a sustained remission, since once a patient's ovarian cancer recurs, it is typically incurable,” Moore said.

“The SOLO-1 results demonstrate the potential of Lynparza maintenance therapy earlier in the treatment pathway and reinforce the importance of identifying a patient's BRCA mutation status at the time of diagnosis.

“These results could change the way we treat women with advanced BRCA-mutated ovarian cancer.”

The SOLO-1 safety profile was in line with that observed in prior clinical trials, AstraZeneca reported, with the most common adverse events being nausea, fatigue or asthenia, vomiting, anaemia, and diarrhoea.

AstraZeneca said it and Merck were exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1.

That trial was testing the effect of Lynparza in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status.

Results from that trial were expected during the second half of 2019.

Lynparza was currently approved in over 60 countries for the treatment of platinum-sensitive relapsed ovarian cancer regardless of BRCA status and in the US, Canada, Japan and Australia for germline BRCA-mutated HER2-negative metastatic breast cancer.