Johnson & Johnson abandons Erleada, Zytiga prostate cancer combination therapy regulatory application

CompilationFan Dongdong

After failing to reach the secondary endpoint of the key Phase III trial, Johnson & Johnson said it will not seek a regulatory application for the prostate cancer drug combination Erleada and Zytiga in the future.

Johnson & Johnson made this decision based on the results of the Phase III ACIS trial of the prostate cancer drug combination Erleada and Zytiga, which was published at the American Society of Clinical Oncology Symposium on Genitourinary Cancer in February this year.

In the trial, all subjects were divided into two groups, and received the treatment of the combination of Erleada and Zytiga and prednisone, or the control group of placebo and ZYTIGA and prednisone, respectively.

However, this test is not a complete failure.

The entire ACIS study population is heterogeneous in terms of androgen receptor (AR) resistance and sensitivity markers.

In this regard, Johnson & Johnson concluded that the combination therapy Erleada and Zytiga for prostate cancer did not show "significant clinical benefits" in the key secondary endpoints, including prolonging the life of patients, improving the long-term use of opioids, and improving the start The time of cytotoxic chemotherapy and the time of pain development, etc.

However, Johnson & Johnson also emphasized that this decision does not mean that the company will completely abandon the research and development results of Erleada and Zytiga.

As a new generation of androgen receptor (AR) inhibitor, Erleada, the world's first drug for the treatment of nmCRPC, can block the activity of male hormones (such as testosterone hormone) and delay the progression of the disease.

Since the introduction of generic drugs in late 2018, generic drugs have been suppressing Johnson & Johnson's Zytiga revenue.

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