HQ Team
June 17, 2024: The US Food and Drug Administration has approved AstraZeneca’s combination therapy, Imfinzi, for adult patients with endometrial cancer, according to a company statement.
The US drug regulator cleared the treatment in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy for patients with primary advanced or recurrent endometrial cancer.
The nod follows results from an end-stage trial which showed data that reduced the risk of disease progression or death by 58% in patients compared to chemotherapy alone.
Endometrial cancer, also known as uterine cancer, forms in the lining of the uterus called the endometrium. Treatment is most effective when it is diagnosed in its early stages.
Cardiovascular disease
It is the sixth most common cancer in women worldwide.
The most common cause of death in patients with endometrial cancer is cardiovascular disease because of the related metabolic risk factors.
In the US, endometrial cancer is the fourth most common cancer in women, with more than 67,880 patients diagnosed yearly and causing about 13,000 deaths in 2024, according to the National Cancer Institute.
Patients diagnosed at an early stage of disease have a five-year survival rate of approximately 80-90%, but there is a significant need for new treatment options for people with advanced disease, where the survival rate falls to less than 20%.
“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,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca.
Combination therapy
“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,” he said.
Shannon N. Westin, principal investigator of the trial, said: “This approval underlines clear evidence that durvalumab plus chemotherapy followed by durvalumab monotherapy delivers important clinical benefits for patients with mismatch repair deficient endometrial cancer.”
The safety and tolerability profile of Imfinzi and the chemotherapy regimen was generally manageable, “well tolerated and broadly consistent with prior clinical trials with no new safety signals,” according to the company statement.
22-nation trial
Regulatory applications are currently under review in the EU, Japan and several other countries based on the trial results.
The trial was conducted in 253 study locations across 22 countries including the US, Europe, South America and Asia.
Imfinzi, both as a single and in combination with other drugs, is being in other countries to treat small lung cancer, metastatic biliary tract cancer, bladder cancer, breast cancer and several gastrointestinal cancers.
