AstraZeneca, Merck & Co.'s Lynparza hits main goal of study as first-line maintenance treatment for advanced ovarian cancer

AstraZeneca and Merck & Co. said Wednesday that a Phase III study of the PARP inhibitor Lynparza (olaparib) as a first-line maintenance treatment for women with newly-diagnosed advanced ovarian cancer met its primary endpoint of progression-free survival (PFS). "The positive results from the PAOLA-1 trial demonstrate a clear potential benefit of adding Lynparza to the standard-treatment bevacizumab for women with advanced ovarian cancer," noted José Baselga, executive vice president of oncology R&D at AstraZeneca.

The trial included women with newly-diagnosed advanced FIGO Stage III-IV high grade serous or endometroid ovarian, fallopian tube or peritoneal cancer, who had a complete or partial response to first-line treatment with platinum-based chemotherapy and Roche's Avastin (bevacizumab). Subjects, which included women both with or without BRCA gene mutations, were randomised to receive Lynparza added to standard-of-care Avastin or Avastin alone.

AstraZeneca and Merck noted that a significant and clinically-meaningful improvement in PFS was seen in the trial, with Lynparza plus Avastin increasing the time women lived without disease progressing or death compared to those taking Avastin alone. The companies indicated that results, including biomarker sub-group analyses, will be presented at an upcoming medical meeting.

"Following positive results from the SOLO-1 trial for women with a BRCA gene mutation, the PAOLA-1 trial marks yet another positive Phase III trial for Lynparza as a first-line maintenance treatment for women with advanced ovarian cancer," remarked Baselga, adding "we look forward to discussing the results with global health authorities as soon as possible."

Last year, AstraZeneca and Merck reported that in the SOLO-1 trial, women with BRCA-mutated advanced ovarian cancer who received Lynparza as first-line maintenance therapy had a significant and clinically-meaningful improvement in PFS compared to placebo. Results later detailed at the European Society for Medical Oncology (ESMO) congress showed that two-year maintenance therapy with Lynparza led to a 70% reduction in the risk of progression or death versus placebo, while 60.4% of patients given the PARP inhibitor remained progression-free at 36 months, versus 26.9% in the placebo arm.

Meanwhile, earlier this month, AstraZeneca and Merck said that a late-stage study of Lynparza in certain men with metastatic castration-resistant prostate cancer met its primary endpoint of radiographic PFS. The drug, which generated sales of $283 million in the second quarter, is approved in over 60 countries for the maintenance treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. It is also authorised in a number of markets as first-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy, as well as being cleared for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy.

Commenting on the latest study results, Bloomberg Intelligence analysts Sam Fazeli and Cinney Zhang said the "success…significantly expands its reach into the first-line ovarian cancer maintenance setting." Analysts expect Lynparza to generate sales of about $2.6 billion in 2023, with Fazeli noting that positive results from the PAOLA-1 trial would add to those estimates.

To read more Top Story articles, click here.