AZ redefines endometrial and ovarian cancer playbook

AstraZeneca Korea is expanding the therapeutic footprint of its PARP inhibitor Lynparza (ingredient: olaparib) in gynecologic cancers, following the drug’s recent approval for advanced or recurrent endometrial cancer and continued evidence of long-term benefit in ovarian cancer.

At a media session held on Tuesday at AstraZeneca Korea’s Seoul headquarters, the company presented updated clinical data on Lynparza’s latest indication in endometrial cancer and reaffirmed its clinical value in ovarian cancer.

The session follows Lynparza’s recent approval from the Ministry of Food and Drug Safety (MFDS) as a maintenance therapy in combination with Imfinzi (ingredient: durvalumab) for patients with mismatch repair-proficient (pMMR) advanced or recurrent endometrial cancer whose disease had not progressed following chemotherapy with carboplatin and paclitaxel in April.

This marks the first-ever approved regimen combining a PARP inhibitor and an immune checkpoint inhibitor for endometrial cancer, offering a novel therapeutic pathway for pMMR patients, who historically derive less benefit from immunotherapy compared to those with mismatch repair-deficient (dMMR) tumors.

“Endometrial cancer is the second most common gynecologic cancer and the sixth most prevalent cancer among women globally,” Professor Lee Jung-yun of the Department of Obstetrics and Gynecology at Severance Hospital said during the session. “The majority of endometrial cancer cases are pMMR, and this subgroup has long represented a therapeutic challenge due to its heterogeneity and limited response to existing immunotherapies.”

According to results from the global phase 3 DUO-E trial, which Lee participated in, the median progression-free survival (PFS) for pMMR patients treated with the combination maintenance therapy of Imfinzi and Lynparza reached 15 months, compared to 9.7 months for those receiving chemotherapy alone.

Although overall survival (OS) data are not yet mature, early trends favor the Lynparza-inclusive regimen.

“Not only did the combination regimen deliver statistically significant and clinically meaningful PFS benefit, it also maintained a quality of life comparable to chemotherapy alone, with manageable adverse events and a relatively low treatment discontinuation rate,” Lee said. “This opens a new chapter for pMMR endometrial cancer, which has long lacked effective options.”

The event also highlighted Lynparza’s leadership in ovarian cancer treatment, reinforced by unprecedented long-term data from the SOLO-1 study. Professor Kim Byoung-gie of the Department of Obstetrics and Gynecology at Samsung Medical Center emphasized that Lynparza remains the only PARP inhibitor with seven-year survival data for BRCA-mutated advanced ovarian cancer.

In SOLO-1, 67 percent of patients treated with first-line Lynparza maintenance were alive at seven years, compared to 46.5 percent in the placebo arm.

"Roughly two out of three women with BRCA-mutated ovarian cancer remained alive seven years after starting Lynparza,” Professor Kim said. “This is a remarkable and clinically meaningful milestone, and many of these patients are considered functionally cured.”

Real-world data from Korea appear to support the global trial results. A retrospective analysis conducted by Asan Medical Center on 70 patients treated with Lynparza monotherapy showed a two-year PFS rate of 75.5 percent and a three-year OS of 98.5 percent, figures that either match or exceed those observed in the SOLO-1 trial.

“This consistency between randomized controlled trial results and Korean real-world experience further underscores the treatment’s relevance in our local clinical practice,” Professor Kim said.

Meanwhile, Lynparza currently holds five approved indications in Korea, covering ovarian, breast, pancreatic, prostate, and now endometrial cancers.

Since its initial approval in ovarian cancer, the drug has become a cornerstone therapy, particularly in BRCA-mutated cases. In October 2021, it gained reimbursement for first-line maintenance in ovarian cancer.

“We are proud to see Lynparza contributing to better outcomes and quality of life for women with cancer,” AstraZeneca Korea Oncology Business Unit Director Lee Hyun-ju said. “With over 10 years of treatment experience in Korea, this latest endometrial cancer approval further elevates Lynparza’s role as a foundational therapy in women’s cancers.”