Phase III Ovarian Cancer Clinical Trial to be Discontinued

According to a story from finanzen.ch, the drug companies Pfizer and Merck recently released a joint statement in which they announced that the companies’ Phase III clinical trial would be discontinued. This clinical trial was testing a combination treatment of chemotherapy and avelumab followed by combination maintenance therapy of avelumab and talazoparib as a treatment for ovarian cancer that was metastatic or locally advanced that had received no prior treatment. 

About Ovarian Cancer

Ovarian cancer can appear on or within the ovary. Ovarian cancer rarely causes distinctive symptoms in its early stages, so many patients are often diagnosed with advanced disease. The risk of getting ovarian cancer is connected to how long a woman has ovulated during her life; women who ovulate for longer periods are at greater risk. Late menopause or early puberty are risk factors, as are not having children, fertility medication, certain genetic variants and mutations (such as BRCA mutations), and exposure to talc, herbicides, and pesticides. Some symptoms of ovarian cancer include fatigue, bloating, a feeling of fullness, loss of appetite, indigestion, abdominal swelling, and pelvic pain. Treatment can include chemo, radiation, surgery, hormone therapy, and immunotherapy. There are many different kinds of ovarian cancer. Five year survival rate is 45 percent in the US. To learn more about ovarian cancer, click here.

Why Discontinue?

The primary reason for this clinical trial’s continuation were the disappointing interim data results for the trial. From these results, both Merck and Pfizer have agreed that the limited benefit from avelumab as observed in these results suggests that continuation of the Phase III clinical trial was not warranted. Other more secondary reasons for the decision include recent changes in the treatment of ovarian cancer, such as the recent approval of a PARP inhibitor. Safety concerns did not factor in to the decision.

Immunotherapy and Ovarian Cancer

The role of immunotherapy such as avelumab in the future treatment of ovarian cancer is still not entirely clear. This trial was the first to test a treatment of this type for this disease. Currently, avelumab is an approved therapy for Merkel cell carcinoma in 45 different countries. 

 


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