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SYNERGY: Novel compound may be effective in mCRPC patients with poor prognosis
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CHICAGO — The addition of the novel custirsen to docetaxel improved outcomes in patients with metastatic castration-resistant prostate cancer who had negative prognostic factors, according to findings presented at the ASCO Annual Meeting.
Cindy Jacobs, MD, PhD, chief medical officer of OncoGeneX Pharmaceuticals, presented data from 984 men who had been treated with docetaxel with or without custirsen (OGX-011, OncoGeneX) — a novel clusterin blocker — as first-line therapy.
After 509 patients had died, overall results from the SYNERGY trial indicated patients in the custirsen arm demonstrated a similar median OS as patients in the control arm (23.4 months vs 22.2 months; HR = 0.93).
The researchers hypothesized that clusterin inhibition may be more useful among a subgroup of patients with poor prognostic factors. Thus, researchers retrospectively dichotomized patients into good and poor risk groups using a prognostic statistical model based on commonly known risk factors in prostate cancer, including presence of liver metastasis, opioid use, a Karnofsky Performance Status of 80 or lower, PSA 59 ng/mL or higher, lactate dehydrogenase 331 IU/L or higher, alkaline phosphatase 92 U/L or higher and hemoglobin less than 124 g/L.
The researchers stratified the analysis for 492 patients in the poor prognosis group. Median OS in the study drug arm was 17 months, compared with 14 months for controls (HR = 0.73; 95% CI, 0.59-.9).
Researchers then conducted an additional analysis for patients with two or fewer of the five negative prognostic factors. In this subgroup, the median OS in the study drug group was 16 months, compared with 13.7 months for controls (HR = 0.73; 95% CI, 0.58-0.92).
“This analysis showed that patients who had increased poor prognostic risk factors and who were treated with custirsen in combination with docetaxel therapy had a statistically significant improvement in overall survival of 3 months, compared to docetaxel alone,” Jacobs told HemOnc Today. — by Rob Volansky
Perspective
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Sumanta Pal, MD
Chemotherapy has an evolving role in advanced prostate cancer. We are starting to use it earlier on the basis of several encouraging trials. One of the challenges we have is that we have not been able to build on chemotherapy. Chi and colleagues previously reported the principal results of this study in which there was no significant benefit of custirsen with chemotherapy. What we see here is that researchers teased out the subset of patients who receive benefit from the drug. Those tend to be patients with a poor prognosis based on laboratory-based data and clinical factors. This is an important study that points to the need to correctly select patients for these clinical trials that may improve outcomes in the future of prostate cancer.
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