Saturday, July 13, 2024

Breakthrough Combo Therapy for Advanced Endometrial Cancer

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AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) have received a recommendation for approval in the European Union (EU) for treating certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as a first-line treatment followed by Lynparza and Imfinzi has been recommended for patients with mismatch repair proficient (pMMR) disease. Imfinzi plus chemotherapy followed by Imfinzi alone has been recommended for patients with mismatch repair deficient (dMMR) disease.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the DUO-E Phase III trial results. This trial, published in the Journal of Clinical Oncology, showed a significant improvement in progression-free survival (PFS) for patients treated with these regimens compared to chemotherapy alone.

Improving Progression-Free Survival

The DUO-E Phase III trial demonstrated a 43% reduction in the risk of disease progression or death for pMMR patients treated with Lynparza and Imfinzi, showing a median PFS of 15.0 months versus 9.7 months with chemotherapy alone. For dMMR patients, Imfinzi alone reduced the risk of disease progression or death by 58%, with a median PFS not reached compared to 7.0 months for the control group.

Endometrial cancer is the fourth most common cancer among women in Europe, with nearly 125,000 diagnoses and over 30,000 deaths in 2022. Patients diagnosed at an early stage have a five-year survival rate of 80-90%, but this rate drops to less than 20% for those with advanced disease. The new treatment options provided by Imfinzi and Lynparza address the significant need for better therapies, particularly for the 70-80% of patients with pMMR disease.

Potential Benefits for Patients

Els Van Nieuwenhuysen, a gynecological oncologist and trial investigator, highlighted the poor prognosis for patients with advanced or recurrent endometrial cancer, especially those with pMMR disease. The recommendation for the combination of durvalumab and olaparib marks a significant step towards improving outcomes for these patients in Europe. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the potential clinical benefits of the Lynparza and Imfinzi combination for patients with endometrial cancer, particularly those with pMMR disease.

The safety profiles of both experimental regimens were manageable and consistent with the known profiles of the individual agents. Regulatory submissions for Imfinzi and Lynparza are under review in Japan and several other countries based on the DUO-E trial results. Imfinzi plus chemotherapy was recently approved for dMMR patients with primary advanced or recurrent endometrial cancer in the US.

Innovative Treatments for Endometrial Cancer

Endometrial cancer originates in the tissue lining of the uterus and is most common in post-menopausal women, with the average age of diagnosis being over 60 years. Most patients are diagnosed at an early stage and treated with surgery and/or radiation, leading to high survival rates. However, patients with advanced disease face a much poorer prognosis.

The DUO-E trial is a three-arm, randomized, double-blind, placebo-controlled, multicenter Phase III trial of first-line Imfinzi plus platinum-based chemotherapy followed by either Imfinzi monotherapy or Imfinzi plus Lynparza as maintenance therapy. The trial randomized 699 patients with newly diagnosed advanced or recurrent epithelial endometrial carcinoma. The primary endpoint was progression-free survival, with secondary endpoints including overall survival, safety, and tolerability.

Endometrial Cancer

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Impact of DUO-E Trial

The DUO-E trial showed that the combination of Imfinzi and Lynparza significantly improves progression-free survival in patients with mismatch repair proficient and deficient endometrial cancer. This marks an important advancement in the treatment of this highly heterogeneous disease, which affects a significant number of women globally.

Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein, blocking its interaction with PD-1 and CD80 proteins, thereby enhancing immune responses against tumors. Imfinzi is already approved for various cancer types, including non-small cell lung cancer, small cell lung cancer, and biliary tract cancer. Lynparza, a first-in-class PARP inhibitor, targets DNA damage response mechanisms in cells with homologous recombination repair deficiencies, such as BRCA mutations.

It is approved for multiple cancer types, including ovarian, breast, pancreatic, and prostate cancers. AstraZeneca’s comprehensive immuno-oncology portfolio includes a broad range of innovative treatments aimed at improving cancer care and outcomes for patients worldwide. The combination of Imfinzi and Lynparza represents a significant step forward in the treatment of endometrial cancer, providing new hope for patients with advanced or recurrent disease.

 

Resource: AstraZeneca, July 01, 2024

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