AstraZeneca (AZ) has shared positive results from a late-stage study of Imfinzi (durvalumab) and Lynparza (olaparib) in advanced or recurrent endometrial cancer.
Endometrial cancer is the sixth most common cancer in women worldwide, with the incidence of the disease expected to increase by approximately 61% in 2050.
Immunotherapy combined with chemotherapy is emerging as a new standard of care for advanced endometrial cancer, particularly for patients with mismatch repair deficient (dMMR) disease. However, AZ has outlined that there remains a “high unmet need” for treatments for the remaining 80% of endometrial cancer patients with mismatch repair proficient (pMMR) disease.
The phase 3 DUO-E study has been evaluating Imfinzi plus platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza as maintenance therapy versus chemotherapy alone.
According to a post-hoc exploratory subgroup analysis of the trial presented at this year’s Society of Gynecologic Oncology Annual Meeting on Women’s Cancer, the median duration of response in pMMR patients in the Lynparza and Imfinzi arm was more than double compared to the control arm, at 18.7 months versus 7.6.
Further secondary endpoints demonstrated “consistent results” for pMMR patients treated with the Lynparza/Imfinzi regimen, AZ said, showing a reduction in the risk of second progression or death by 32% and improvement in time to first and second subsequent treatments.
In the overall trial population, the Lynparza/Imfinzi regimen was shown to extend overall response rate and duration of response, as well as consistently improve benefit in secondary endpoints.
For Imfinzi plus chemotherapy followed by Imfinzi alone, consistent benefits were observed regardless of MMR status, with the greatest benefit observed in patients with dMMR disease across all secondary endpoints, including objective response rate and duration of response.
Susan Galbraith, executive vice president, oncology research and development, AZ said: “DUO-E results have shown that adding Imfinzi to chemotherapy delivers better outcomes for patients with advanced endometrial cancer.
“In addition, to achieve optimal clinical benefit for patients with the greatest unmet need – those with mismatch repair proficient disease – the addition of Lynparza further enhances the effect of checkpoint inhibition in endometrial cancer.”
The company has said that regulatory filings for DUO-E have been accepted for review by regulatory authorities across the world, including in the US and Europe.