#erleada

 Findings of a phase 3 clinical trial published in The Lancet Oncology on September 30, 2021, by an international research team led by Dr. Fred Saad, a researcher at the CHUM Research Centre, a Université de Montréal professor and the holder of the Raymond Garneau Chair in Prostate Cancer Research indicate that the combination of Zytiga (abiraterone), prednisone and Erleada (apalutamide) can delay the progression of metastatic castrate-resistant prostate cancer. 

The trial was a collaboration with 167 hospitals in 17 countries. The study, called ACIS, identified for the first time a combination of three drugs that slowed the progression of metastases by more than seven months. This finding is a significant therapeutic breakthrough for treating advanced prostate cancer. 

The trial evaluated 982 men between the end of 2014 and the middle of 2016 and divided them randomly into two groups (randomized, double-blind trial). Of the volunteers, 492 received apalutamide (an anti-androgen) combined with abiraterone (an androgen synthesis inhibitor) and prednisone (an anti-inflammatory drug). 

The control group of 490 men received only abiraterone and prednisone.  This well-tolerated therapeutic trio was administered to men with metastatic castration-resistant prostate cancer. Prostate cancer is considered castration-resistant when cancer progresses despite hormone therapy. 

By following the progression of the cancer through radiologic scans, the researchers were able to show that the men in the triple treatment group lived 24 months (median) without signs of disease progression, compared to 16.6 months for those in the standard of care control group. 

The researchers have suggested that additional studies will help to accurately identify the sub-categories of men who would most benefit from this combination of drugs. 

At Cancer ABCs, we acknowledge the great value that the many current, ongoing clinical trials of combinations of approved drugs can bring to our treatment protocol. However, we suggest that, in addition to combination studies, there need to be other studies that evaluate the survival benefit of sequencing the same drugs and comparing these results to the combination trials. Included in the comparison, we wish to see an evaluation of patient-reported side effects between the sequenced and combination trials.

 REFERENCES 

According to Janssen Pharmaceuticals a preplanned early analysis of the Phase III TITAN trial shows that Erleada (apalutamide) has met the both of the trial’s primary endpoints in the treatment of men with metastatic castration-sensitive prostate cancer (CSPC). Janssen has indicated that they will be seeking regulatory approval for this expanded indication.

According to TITAN's primary endpoints, once-daily 240 mg oral Erleada plus androgen deprivation therapy (ADT) significantly improved both radiographic progression-free survival (rPFS) and overall survival (OS) vs. placebo plus androgen deprivation therapy. 

TITAN is a double-blind, international trial that enrolled 1,052 newly diagnosed men with metastatic disease, regardless of prognostic risk, volume of disease, prior treatment with docetaxel or therapy of localized disease.