AstraZeneca announces analysis from its DUO-E Phase III trial

The latest analysis of the results from the DUO-E Phase III trial showed Imfinzi plus platinum-based chemotherapy followed by Imfinzi plus Lynparza demonstrated an improvement in multiple key secondary efficacy endpoints, particularly in patients with mismatch repair proficient advanced or recurrent endometrial cancer compared to chemotherapy alone. These results will be presented in a late-breaking session at the 2024 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in San Diego, California. A post-hoc exploratory subgroup analysis assessed patients by mismatch repair status, a biomarker of interest in endometrial cancer. In this analysis, median duration of response in pMMR patients in the Lynparza and Imfinzi arm was more than double versus the control arm. Additional secondary endpoints showed consistent results for pMMR patients treated with Lynparza and Imfinzi, demonstrating a reduction in the risk of second progression or death by 32% for the combination versus the control arm, and improvement in time to first and second subsequent treatments. Imfinzi plus chemotherapy followed by Imfinzi monotherapy showed consistent benefit regardless of MMR status, with the greatest benefit observed in patients with mismatch repair deficient disease across all secondary endpoints. In the overall trial population, results in the Lynparza and Imfinzi arm showed extended ORR and DoR, as well as consistently improved benefit in secondary endpoints, including overall survival, time to first subsequent therapy, PFS2 and time to second subsequent therapy. These data are consistent with the positive primary analysis presented last year, which showed that the Imfinzi arm and the Lynparza and Imfinzi arm both demonstrated a statistically significant and clinically meaningful improvement in PFS compared to chemotherapy alone in the overall trial population. The safety profiles of both experimental regimens were manageable, well-tolerated and broadly consistent with the known profiles of the individual agents. Regulatory filings for DUO-E have been accepted for review by regulatory authorities across the world including in the US, Europe and Japan.