In a groundbreaking development, the DUO-E Phase III trial has demonstrated that Imfinzi (durvalumab), in combination with platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib), significantly improves progression-free survival (PFS) in patients with newly diagnosed advanced or recurrent endometrial cancer. These findings were presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the Journal of Clinical Oncology.
The results of the DUO-E trial revealed that patients treated with Imfinzi in combination with chemotherapy, followed by either Imfinzi monotherapy or Imfinzi plus Lynparza, experienced a substantial reduction in the risk of disease progression or death. In the overall trial population, the risk of disease progression or death was reduced by 45% and 29%, respectively, compared to chemotherapy alone. The median PFS was 15.1 months for the Imfinzi plus Lynparza arm, emphasizing the clinical significance of this combination therapy.
Additionally, the study conducted an exploratory subgroup analysis based on Mismatch Repair (MMR) status, a key biomarker in endometrial cancer. Results showed a reduction in the risk of disease progression or death in both the Imfinzi plus Lynparza and Imfinzi arms for patients with proficient MMR (pMMR) and deficient MMR (dMMR), indicating the broad potential of this treatment approach.
Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine, hailed these findings as groundbreaking, highlighting the potential of combining immunotherapy with a PARP inhibitor to enhance outcomes for endometrial cancer patients.
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, expressed enthusiasm for these results, emphasizing the need for new treatment options for advanced endometrial cancer patients, especially those with proficient MMR status.
The study also explored Imfinzi’s performance based on PD-L1 status. In patients with PD-L1 positivity, the combination therapy reduced the risk of disease progression or death by 58%, demonstrating the potential for significant benefit in this subgroup.
For the PD-L1 negative population, treatment still showed promise with a 20% risk reduction in the Imfinzi plus Lynparza arm and an 11% reduction in the Imfinzi arm.
The safety profiles of both regimens were consistent with previous clinical trials and the known profiles of the individual medicines. Common adverse events included anemia, nausea, fatigue, and neuropathy, with variations between the two arms of the study.
Endometrial cancer is a heterogeneous disease, and these results provide hope for a more effective treatment approach, particularly for patients with advanced or recurrent forms of the disease.
These promising findings from the DUO-E trial represent a significant step forward in the treatment of endometrial cancer. Discussions with regulatory authorities are underway, to bring these innovative treatment approaches to patients as soon as possible.
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