Saturday, July 13, 2024

FDA Approves Imfinzi for Endometrial Cancer: Significant Progress in Treatment

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Endometrial cancer that is mismatch repair deficient (dMMR) has a new treatment option as the Food and Drug Administration (FDA) has approved AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy, followed by Imfinzi monotherapy, for adults with primary advanced or recurrent cases. This approval is grounded in the promising results from the DUO-E Phase III trial. The study demonstrated that the combination therapy significantly reduced the risk of disease progression or death by 58% in patients with dMMR endometrial cancer compared to chemotherapy alone.

Principal investigator Shannon N. Westin, professor of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, emphasized the critical importance of introducing new and effective treatment options early in the patient care process. Westin highlighted the urgency in addressing the rising incidence and mortality rates of endometrial cancer, stating, “With the incidence and mortality of endometrial cancer expected to continue to increase significantly in the coming decades, it is more important than ever that we bring new treatment options to patients at the earliest possible moment in their care.”

Westin elaborated on the potential impact of this new approval, saying, “Endometrial cancer is a particularly challenging disease, with many patients facing limited treatment options after initial therapies fail. The approval of Imfinzi (durvalumab) in combination with chemotherapy, followed by durvalumab monotherapy, represents a significant advancement in the management of this disease, particularly for those with mismatch repair deficient endometrial cancer. This subgroup of patients often has a more aggressive disease course and fewer effective treatment options, making this approval a crucial development.”

Durvalumab and Chemotherapy Show Significant Benefits for Endometrial Cancer Patients

Westin continued, “The DUO-E Phase III trial has provided clear and compelling evidence that the combination of durvalumab and chemotherapy, followed by maintenance durvalumab monotherapy, can significantly improve clinical outcomes. The trial showed a remarkable 58% reduction in the risk of disease progression or death compared to chemotherapy alone, which is a substantial benefit for patients. This approval underlines the importance of continued research and development in the field of gynecologic oncology and the necessity of making innovative treatments available to patients as soon as possible.”

She also discussed the broader implications of this approval for the future of endometrial cancer treatment. “The data from the DUO-E trial not only demonstrate the efficacy of this combination therapy but also pave the way for future research into similar approaches for other gynecologic cancers. The success of this trial highlights the potential for immunotherapy and targeted treatments to transform the standard of care in oncology. By integrating these therapies earlier in the treatment regimen, we can offer patients improved survival outcomes and a better quality of life.”

Westin stressed the collaborative effort required to achieve such milestones, stating, “The progress we have made with durvalumab and chemotherapy for dMMR endometrial cancer is a testament to the dedication of researchers, clinicians, and the support from patients and their families who participate in clinical trials. This collective effort is essential in driving forward innovations in cancer treatment and ultimately improving patient outcomes. The approval of this new treatment regimen is a significant step forward, but our work is far from over. Continued investment in research and a commitment to developing new therapies will be crucial as we strive to combat the increasing burden of endometrial cancer.”

Endometrial Cancer

DUO-E Trial Demonstrates Significant Efficacy of Imfinzi for Endometrial Cancer

The DUO-E trial was a three-arm, randomized, double-blind, placebo-controlled, multicenter study that evaluated first-line Imfinzi (1120 mg) plus platinum-based chemotherapy (carboplatin and paclitaxel) followed by either Imfinzi monotherapy or Imfinzi plus Lynparza (olaparib) as maintenance therapy versus platinum-based solo chemotherapy for patients with newly diagnosed advanced or recurrent endometrial cancer. The trial included 699 patients who received treatment every three weeks alongside chemotherapy. For cycles 4-6, patients without disease progression received either a 1500 mg treatment of Imfinzi or a placebo every four weeks as maintenance therapy, with Lynparza (300 mg BID) or placebo until disease progression.

The study’s primary endpoint was progression-free survival, with secondary endpoints including overall survival, safety, and tolerability. The findings, published in the Journal of Clinical Oncology, revealed that durvalumab reduced the risk of disease progression or death by 29% compared to the control group. Furthermore, the combination therapy of durvalumab and chemotherapy reduced the risk of disease progression or death by 45% compared to the control group. AstraZeneca reported that the safety and tolerability profile of the combination therapy was consistent with previous findings, with no new safety signals.

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Adverse events (AEs) such as anemia, nausea, fatigue or asthenia, and alopecia were observed during the study. In the maintenance phase, the reported AEs were primarily nausea, anemia, and fatigue or asthenia, which were managed through dose modification rather than treatment discontinuation. Treatment discontinuation rates were 18.6% in the control arm, 20.9% in the durvalumab arm, and 24.4% in the durvalumab plus olaparib arm.

FDA Approval of Imfinzi Brings Hope Amid Rising Endometrial Cancer Mortality Rates

Endometrial cancer is the most common form of cancer affecting women in the United States. It is projected that by the end of 2024, 13,250 women will succumb to the disease. Alarmingly, endometrial cancer is one of the few cancers with an increasing mortality rate, with the death rate rising approximately 1.7% per year since the early 2000s.

Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted the significance of this advancement, stating, “There have been limited advances in the treatment of endometrial cancer in the last few decades, and continued innovation is critical as the burden of this cancer is expected to grow in the future. Immunotherapy in combination with chemotherapy is emerging as a new standard of care in this setting, and the approval of Imfinzi offers an important new option for patients with mismatch repair deficient disease.”

In summary, the FDA’s approval of Imfinzi in combination with chemotherapy, followed by Imfinzi monotherapy, marks a significant milestone in the treatment of primary advanced or recurrent dMMR endometrial cancer. This decision is supported by robust clinical trial results showing a substantial reduction in the risk of disease progression or death. The approval not only provides a new standard of care for this patient population but also underscores the critical need for ongoing innovation in the treatment of endometrial cancer, a disease with rising incidence and mortality rates. As new therapeutic options become available, they offer hope and improved outcomes for patients facing this challenging diagnosis.

 

Resource: AstraZeneca, June 17, 2024

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