AstraZeneca: The U.S. FDA Approved IMFINZI in Combination with Carboplatin and Paclitaxel followed by IMFINZI Monotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer

US FDA Approval for AstraZeneca’s IMFINZI

AstraZeneca (AZN): The trial results of the FDA newly approved combination products demonstrated a reduction in the risk of disease progression or death by 58% in patients with dMMR endometrial cancer versus chemotherapy alone.  

Endometrial cancer is the fourth most common cancer in women In the United States.  More than 66,000 patients diagnosed and almost 12,000 deaths in 2022. 

Patients who are diagnosed at an early stage of the cancer have a five-year survival rate of approximately 80-90%. Those diagnosed in advanced stage, the survival rate falls to less than 20%, making new treatments options significantly required.  

The Basis for the Approval of the AstraZeneca Product

The FDA approval was based on the results of a prespecified exploratory subgroup analysis by MMR status in the DUO-E Phase III trial.  The results from the DUO-E were published in the Journal of Clinical Oncology.

Maintenance Therapy

LYNPARZA® (olaparib) and IMFINZI arm, which investigated IMFINZI plus chemotherapy followed by IMFINZI plus LYNPARZA as maintenance therapy, has also met the primary endpoint of progression-free survival (PFS). The trial continues to assess OS as a key secondary endpoint for both arms.

Regulatory applications for both IMFINZI as well as IMFINZI and LYNPARZA regimens are currently under review in the EU, Japan and several other countries based on the DUO-E results.

Shannon N. Westin, Professor of Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center, and principal investigator of the trial, said, “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. 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.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “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.”

The safety and tolerability profile of the IMFINZI and chemotherapy regimen was generally manageable, well tolerated and broadly consistent with prior clinical trials with no new safety signals. 

Patients and investors must read the Important Safety Information in the firm’s press release in the company’s website.  

Prohost Observations 

We believe that the FDA approval of the new combinations will bring a life saving new treatment option to adult patients with primary advanced or recurrent endometrial cancer.  

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