Results from primary analysis of the DUO-E Phase III trial presented at ESMO

Results from the primary analysis of the DUO-E Phase III trial showed that IMFINZI plus platinum-based chemotherapy, followed by either IMFINZI monotherapy or IMFINZI plus LYNPARZA, both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to chemotherapy alone in the overall trial population of patients with newly diagnosed advanced or recurrent endometrial cancer. These results will be presented today in a proffered paper session at the 2023 European Society for Medical Oncology Congress in Madrid, Spain and simultaneously published online in the Journal of Clinical Oncology. In the overall trial population, results showed that treatment with IMFINZI plus chemotherapy followed by IMFINZI plus LYNPARZA and treatment with IMFINZI plus chemotherapy followed by IMFINZI monotherapy demonstrated a reduction in the risk of disease progression or death, by 45% and 29%, respectively, versus chemotherapy alone. Median PFS was 15.1 months in the IMFINZI plus LYNPARZA Arm and 9.6 months in the Control Arm. Mismatch repair status is a biomarker of interest in endometrial cancer, therefore a prespecified exploratory subgroup analysis by MMR status was conducted in DUO-E. Results from the analysis of mismatch repair proficient patients showed a reduction in the risk of disease progression or death in both the IMFINZI plus LYNPARZA and the IMFINZI Arms, by 43% and 23%, respectively, versus the Control Arm. Median PFS was 15 months in the IMFINZI plus LYNPARZA Arm and 9.7 months in the Control Arm. Results from the analysis of mismatch repair deficient patients showed a similar reduction in the risk of disease progression or death in both the IMFINZI plus LYNPARZA and the IMFINZI Arms, by 59% and 58%, respectively, versus the Control Arm. Interim overall survival data showed a favorable trend for both treatment regimens in the overall population. PD-L1 is a known biomarker for IMFINZI in other indications and a prespecified analysis based on PD-L1 status showed, in the PD-L1 positive population, that treatment reduced the risk of disease progression or death by 58% and 37% in the IMFINZI plus LYNPARZA and the IMFINZI Arms, respectively, versus the Control Arm. Median PFS was 20.8 months in the IMFINZI plus LYNPARZA Arm and 9.5 months in the Control Arm. In the PD-L1 negative population, treatment reduced the risk of disease progression or death by 20% and 11% in the IMFINZI plus LYNPARZA and the IMFINZI Arms, respectively, versus the Control Arm. The safety and tolerability profiles of both regimens were broadly consistent with those observed in prior clinical trials and the known profiles of the individual medicines. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation.