Lynparza Becomes China's First PARP Inhibitor Approved for First-Line Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer

Today, AstraZeneca and MSD jointly announced that the National Medical Products Administration of China has officially approved their PARP inhibitor Lynparza (generic name: olaparib) for first-line maintenance treatment in patients with BRCA-mutated advanced ovarian cancer. Benefiting from strong support in ChinaPharmaceuticalsInnovation and Accelerated Approval of New Drugs for Urgent Clinical Needs: Olaparib Becomes the First PARP Inhibitor Approved in China for First-Line Maintenance Therapy in Ovarian Cancer.

This approval is based on the positive results from the pivotal Phase III SOLO-1 trial. The study results demonstrated that, compared with the placebo group, olaparib as first-line maintenance therapy reduced the risk of disease progression or death by 70% in patients with BRCA-mutated advanced ovarian cancer who had achieved a complete or partial response following platinum-based chemotherapy. After a median follow-up of 41 months, the median progression-free survival (PFS) was not reached in the olaparib group, whereas the median PFS in the placebo group was 13.8 months. In the olaparib group, 60% of patients were free from disease progression at 3 years, compared with 27% in the placebo group.

“Ovarian cancer is the most aggressive malignancy among gynecologic cancers, with the lowest 5-year survival rate of only 39%, and 70% of patients experience recurrence within three years. Over the past three decades, treatment for ovarian cancer has primarily relied on surgery and chemotherapy, with a lack of significant breakthroughs,” said Professor Wu Xiaohua, Director of the Department of Gynecologic Oncology at Fudan University Shanghai Cancer Center. “In fact, beyond traditional therapies, maintenance therapy is a crucial strategy for controlling disease progression in advanced ovarian cancer. The approval of olaparib for first-line maintenance treatment will guide personalized, precision medication from the initial stage of intervention, holding promise for long-term delay of disease progression. This represents a milestone in the history of precision treatment for ovarian cancer in China.”

Olaparib is a significant outcome of the strategic collaboration on innovative oncology drugs between AstraZeneca and MSD. Mr. Wang Lei, Executive Vice President of AstraZeneca, President of International Business and China, stated, “As the first PARP inhibitor approved in China, olaparib has breakthroughly ushered the treatment of advanced ovarian cancer into the era of targeted therapy. Today, with the further expansion of its indications and approval as a first-line maintenance therapy for ovarian cancer, olaparib once again demonstrates AstraZeneca’s commitment and action in providing ‘patient-centric’ disease solutions based on the pain points and needs of Chinese patients. In the future, we will work closely with the government and industry partners to further explore the integration of diagnosis and treatment in the field of ovarian cancer, bringing patients comprehensive disease management solutions from prevention, diagnosis to treatment and rehabilitation, thereby helping to improve the level of diagnosis and treatment of female tumors in China.”

“The approval of olaparib is based on the SOLO-1 study, particularly the data from the Chinese subgroup population first presented during the 2019 ASCO Annual Meeting. The approval of this indication reflects the Chinese government’s commitment to accelerating the review and approval of innovative medicines to benefit a broad population of cancer patients,” said Lo Wan-li, Senior Vice President of MSD globally and President of MSD China. “The approval of olaparib for first-line maintenance treatment in advanced ovarian cancer with BRCA mutations is the result of collaborative efforts between the Chinese government and industry partners, grounded in robust clinical data, to jointly benefit more cancer patients. We extend our gratitude to the Chinese government, physicians, and patients for their contributions to the SOLO-1 study, and we look forward to working closely with AstraZeneca to further enhance the accessibility of olaparib in China.”

Previously, olaparib was first approved in China in August 2018 for maintenance therapy in patients with platinum-sensitive recurrent ovarian cancer, and it was successfully included in the National Reimbursement Drug List (2019 Edition) on November 28, 2019.

# About Ovarian Cancer

According to statistics, there are approximately 52,100 new cases of ovarian cancer and about 22,500 deaths in China each year. Over the past decade, the incidence rate of ovarian cancer in China has increased by 30%, and the mortality rate has risen by 18%. Among gynecological malignancies, ovarian cancer ranks third in incidence after cervical cancer and endometrial cancer, yet it has the lowest five-year survival rate at only 39%¹, and the highest three-year recurrence rate, reaching 70%². Due to the lack of effective screening methods, more than 70% of Chinese patients are diagnosed at an advanced stage, highlighting an urgent need to address this significant clinical challenge.

About Olaparib

Olaparib is the first oral poly(ADP-ribose) polymerase (PARP) inhibitor that targets and inhibits the DNA damage repair enzyme PARP, thereby killing cancer cells. Relevant in vitro studies have shown that olaparib-induced cytotoxicity may involve the inhibition of PARP enzymatic activity and promote the formation of PARP-DNA complexes, ultimately leading to DNA damage and cancer cell death. In the field of ovarian cancer treatment, the emergence of olaparib has broken the therapeutic stalemate. Currently, olaparib is undergoing clinical trials for a range of tumors with DNA damage response (DDR) deficiencies or DDR dependencies.

About the SOLO-1 Study

SOLO-1 was a Phase III, randomized, double-blind, placebo-controlled, multicenter trial designed to evaluate the efficacy and safety of olaparib tablets (300 mg twice daily) versus placebo as maintenance monotherapy in patients with BRCA-mutated advanced ovarian cancer who had received first-line platinum-based chemotherapy. The study randomly enrolled 391 patients with deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 mutations who had achieved a complete or partial response following platinum-based chemotherapy. Patients were randomized (2:1 ratio) to receive either olaparib or placebo for two years or until disease progression. For patients who remained in partial response after two years, investigators determined whether they could continue treatment. The primary endpoint was progression-free survival; key secondary endpoints included time to second disease progression or death, time to first subsequent therapy, and overall survival.