THE "NEW" PROSTATE CANCER INFOLINK

Exelixis has announced that the COMET-1 trial of cabozantinib in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) has failed to show a statistically significant survival benefit. The company has also stopped enrollment into the COMET-2 trial.

The COMET-1 trial was a Phase III, randomized trial comparing treatment with cabozantinib to treatment with prednisone among men who had already progressed after earlier treatment on standard hormonal therapy, after docetaxel-based chemotherapy, and after treatment with abiraterone acetate and/or emnzalutamide. According to the first of two media releases, issued yesterday, top-line results showed a median overall survival of 11.0 months for men in the cabozantinib arm of the trial was 11.0 months compoared to 9.8 months for men in the prednisone arm (hazard ratio [HR] = 0.90; p-value 0.212).

In a second media release, issued this morning, the company announced that it would be halting enrollment in the COMET-2 trial, which had been designed to investigate whether cabozantinib had a palliative effect on cancer-related pain in a very similar set of patients with mCRPC.

There is little doubt that it is becoming a great deal harder to demonstrate a significant survival benefit in men with mCRPC who are treated with third-line therapy after docetaxel-based chemotherapy and after either abiraterone acetate or enzalutamide (or both). For new drugs to demonstrate real value in such patients, it seems highly likely that they are going to need to work in ways that are very different to those of available forms of treatment.

Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: cabozantinib, castration-resistant, mCRPC, metastatic |