Two AstraZeneca Endometrial Cancer Treatments Approved in EU

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Imfinzi (durvalumab) and Lynparza (olaparib), two AstraZeneca products, have been approved as treatments for certain people who have primary advanced or recurrent endometrial cancer throughout the European Union (EU), AstraZeneca said in a press release on Aug. 14, 2024 (1). The European Commission’s approval follows a positive opinion by the Committee for Medicinal Products for Human Use based on a subgroup analysis of mismatch repair (MMR) status in a Phase III trial (DUO-E), the results of which were published in the Journal of Clinical Oncology (2).

The approval covers several conditions: first, Imfinzi plus chemotherapy as first-line treatment, followed by Lynparza and Imfinzi, may be used in patients with mismatch repair proficient (pMMR) disease, and second, Imfinzi plus chemotherapy followed again by Imfinzi alone can be used for patients with mismatch repair deficient (dMMR) disease (1).

“This approval of Imfinzi and Lynparza regimens marks the first-ever approval for a combination of an immunotherapy and PARP [poly-adenosine diphosphate ribose polymerase] inhibitor in endometrial cancer and a major step forward for patients,” Dave Fredrickson, executive vice president of AstraZeneca’s oncology business unit, said in the press release (1,2). “In Europe, endometrial cancer is the fourth-most common cancer in women, and until now, the 70% to 80% of patients who have mismatch repair proficient disease have had few available treatment options.”

Endometrial cancer originates in the tissue lining of the uterus and is most common in women who have experienced menopause, with an average age at the time of diagnosis of over 60 years old. Approximately 125,000 women in Europe were diagnosed with endometrial cancer in 2022.

“This approval is welcome news for patients with advanced or recurrent endometrial cancer in Europe, especially those with mismatch repair proficient disease who have limited options,” Els Van Nieuwenhuysen, gynecological oncologist at UZ Leuven, Belgium, and DUO-E trial investigator, said in a press release. “The olaparib and durvalumab as well as the durvalumab regimens now have the potential to improve outcomes for all patients in this setting in Europe, regardless of mismatch repair status.”

The regimen of Imfinzi and Lynparza investigated in the trial reduced the risk of disease progression or death in patients with pMMR disease by 43% versus a control group, with a median 15.0 months versus 9.7 months (1). While a median number of months was not reached in the portion that tested the Imfinzi regimen in patients with dMMR disease, efficacy was measured at 58% in terms of reducing disease progression or death risk.

Imfinzi plus chemotherapy has been approved for dMMR patients with primary advanced or recurrent endometrial cancer in the United States, and the results of the DUO-E trial are currently being studied in Japan and other countries which are considering regulatory submissions for both Imfinzi and Lynparza, according to AstraZeneca (1).

References

1. AstraZeneca. Lynparza and Imfinzi Combination Approved in the EU for Patients with Mismatch Repair Proficient Advanced or Recurrent Endometrial Cancer. Press Release. Aug. 14, 2024.
2. Westin, S.N.; Moore, K.; Chon, H.S.; et al. Durvalumab Plus Carboplatin/Paclitaxel Followed by Maintenance Durvalumab with or Without Olaparib as First-Line Treatment for Advanced Endometrial Cancer: The Phase III DUO-E Trial. J. Clin. Oncol. 2023, 42 (3) 283–299. DOI: 10.1200/JCO.23.02132