Phase III Trial Data Reinforce Potential of Imfinzi and Lynparza and Imfinzi Regimen for Endometrial Cancer
Analysis of trial results show Imfinzi and Lynparza displayed a strong clinical benefit and more than doubled median duration of response vs. chemotherapy.
Analysis of results from the DUO-E Phase III trial have reinforced the potential of Imfinzi (durvalumab) plus platinum-based chemotherapy followed by Imfinzi plus Lynparza (olaparib) (Lynparza and Imfinzi arm) in patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer compared to chemotherapy alone, according to a press release.1
In patients assessed by mismatch repair (MMR) status, the median duration of response (DoR) in pMMR patients in the Lynparza and Imfinzi arm was more than double versus the control arm (18.7 months versus 7.6). 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.
The Imfinzi plus chemotherapy followed by Imfinzi monotherapy regimen showed consistent benefit regardless of MMR status, with the greatest benefit observed in patients with mismatch repair deficient (dMMR) disease across all secondary endpoints.
“Endometrial cancer diagnoses are rapidly rising, yet very little has changed in recent years to advance new treatments for the approximately eighty per cent of patients with advanced or recurring disease who are mismatch repair proficient,” Hye Sook Chon, gynaecologic oncologist at the Moffitt Cancer Center in Tampa, Florida, and trial investigator said in the press release. “DUO-E results demonstrate the benefit of durvalumab plus chemotherapy followed by durvalumab for patients with dMMR status and provide compelling evidence for the addition of olaparib to this regimen for patients with pMMR status.”
Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins. It is currently approved in several countries across multiple tumor types. Lynparza is a first-in-class PARP inhibitor, also approved across multiple tumors.
“DUO-E results have shown that adding Imfinzi to chemotherapy delivers better outcomes for patients with advanced endometrial cancer,” Susan Galbraith, executive vice president, oncology R&D, AstraZeneca said in the release. “In addition, to achieve optimal clinical benefit for patients with the greatest unmet need—those with mismatch repair proficient disease—the addition of Lynparza further enhances the effect of checkpoint inhibition in endometrial cancer.”
Reference
1. Lynparza and Imfinzi demonstrated strong clinical benefit and more than doubled median duration of response vs. chemotherapy in patients with mismatch repair proficient advanced or recurrent endometrial cancer. News release. March 18, 2024. Accessed March 19, 2024. https://www.astrazeneca.com/media-centre/press-releases/2024/lynparza-and-imfinzi-demonstrated-strong-clinical-benefit-and-more-than-doubled-median-duration-of-response-vs-chemotherapy.html
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Regulatory Compliance With eCOAs
April 26th 2024In the fourth and final part of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA discusses how the regulatory stance on electronic clinical outcome assessments has changed over the years and what it could look like in the future.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
