AstraZeneca and Merck, known as MSD outside of the United States and Canada, today announced that LYNPARZA has been approved in China as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

In China, ovarian cancer is the third most common gynecologic cancer, and the five-year survival rate is approximately 39%, with more than 70% of women diagnosed with advanced disease (stage III or IV). In 2020, there were over 55,000 new cases of ovarian cancer diagnosed in China.

The approval by China’s National Medical Products Administration was based on an HRD-positive subgroup exploratory analysis of the Phase 3 PAOLA-1 trial, which showed LYNPARZAplus bevacizumab following response to platinum-based chemotherapy demonstrated a substantial progression-free survival (PFS) improvement versus bevacizumab alone for patients with HRD-positive advanced ovarian cancer.

During the European Society for Medical Oncology (ESMO) Congress 2022, updated results were presented from the PAOLA-1 trial, demonstrating that LYNPARZAplus bevacizumab provided a clinically meaningful improvement in overall survival (OS) in an exploratory subgroup analysis of HRD-positive patients with advanced ovarian cancer. These OS results were not statistically significant.

Professor Ding Ma, member of the Chinese Academy of Engineering, said, “Ovarian cancer has the highest fatality rate among gynecologic cancers in China. The emergence of PARP inhibitors and their application in the first-line treatment of ovarian cancer could help patients delay disease progression and achieve long-term remission. In the PAOLA-1 trial, the combination of olaparib and bevacizumab demonstrated clinically meaningful improvements in overall survival. This approval provides HRD-positive patients with a new option for first-line maintenance therapy.”

Professor Beihua Kong, chairman of the gynecological oncology branch of the Chinese Medical Association, said, "Ovarian cancer has entered the era of precision medicine, and HRD detection (including BRCA1/2 mutations) has important clinical value for newly diagnosed patients with advanced ovarian cancer to help guide first-line treatment decisions. The approval of the combination of olaparib and bevacizumab brings a clinically meaningful survival benefit to HRD-positive patients, and further reflects the importance of a precision approach to help guide treatment decisions in ovarian cancer."

Dave Fredrickson, executive vice president, oncology business unit, AstraZeneca, said, “The maintenance treatment of LYNPARZAin combination with bevacizumab has shown to both improve progression-free survival and provide a clinically meaningful improvement in overall survival in patients with HRD-positive advanced ovarian cancer following response to platinum-based chemotherapy. I am thrilled we can now bring this targeted treatment option to these patients in China.”

Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories, said, “This approval is an important milestone for patients with newly diagnosed advanced ovarian cancer in China and underscores the critical importance of HRD testing for all women with advanced ovarian cancer at the point of diagnosis.”

LYNPARZA in combination with bevacizumab is approved in the U.S., European Union and several other countries as a first-line maintenance treatment for patients with HRD-positive advanced ovarian cancer and is currently under regulatory review in other countries around the world.