OGX-011 early results promising

[JimJimJimJim]

Clusterin is a protein in the body with a lot of activity, including cell death.

A new drug - OGX-011 - inhibits clusterin activity.

This seems to have a cancer-slowing effect.

In the small trial below, all the men had standard chemotherapy for castrate resistant prostate cancer (docetaxel and prednisone).

Half the men had OGX-011 added, half did not.

The men who had the OGX-011 added lived an average of 7 months more.

OGX-011 is experimental.

Small trials like this one can sometimes get good results by chance.

So good results from a larger (Phase III) trial will be needed before this drug becomes available.

J Clin Oncol. 2010 Sep 20;28(27):4247-54. Epub 2010 Aug 23.

Randomized phase II study of docetaxel and prednisone with or without OGX-011 in patients with metastatic castration-resistant prostate cancer.

Chi KN, Hotte SJ, Yu EY, Tu D, Eigl BJ, Tannock I, Saad F, North S, Powers J, Gleave ME, Eisenhauer EA.

Source

British Columbia Cancer Agency, Vancouver, British Columbia, Canada. kchi@bccancer.bc.ca

Abstract

PURPOSE:

To determine the clinical activity of OGX-011, an antisense inhibitor of clusterin, in combination with docetaxel/prednisone in patients with metastatic castration-resistant prostate cancer.

PATIENTS AND METHODS:

Patients were randomly assigned 1:1 to receive docetaxel/prednisone either with (arm A) or without (arm OGX-011 640 mg intravenously weekly. The primary end point was the proportion of patients with a prostate-specific antigen (PSA) decline of ≥ 50% from baseline, with the experimental therapy being considered of interest if the proportion of patients with a PSA decline was more than 60%. Secondary end points were objective response rate, progression-free survival (PFS), overall survival (OS), and changes in serum clusterin.

RESULTS:

Eighty-two patients were accrued, 41 to each arm. OGX-011 adverse effects included rigors and fevers. After cycle 1, median serum clusterin decreased by 26% in arm A and increased by 0.9% in arm B (P < .001). PSA declined by ≥ 50% in 58% of patients in arm A and 54% in arm B. Partial response occurred in 19% and 25% of patients in arms A and B, respectively. Median PFS and OS times were 7.3 months (95% CI, 5.3 to 8.8 months) and 23.8 months [jm:with OGX-011] (95% CI, 16.2 months to not reached), respectively, in arm A and 6.1 months (95% CI, 3.7 to 8.6 months) and 16.9 months [jm:without OGX-011] (95% CI, 12.8 to 25.8 months), respectively, in arm B. Baseline factors associated with improved OS on exploratory multivariate analysis were an Eastern Cooperative Oncology Group performance status of 0 (hazard ratio

---

, 0.27; 95% CI, 0.14 to 0.51), presence of bone or lymph node metastases only (HR, 0.45; 95% CI, 0.25 to 0.79), and treatment assignment to OGX-011 (HR, 0.50; 95% CI, 0.29 to 0.87).

CONCLUSION:

Treatment with OGX-011 and docetaxel was well tolerated with evidence of biologic effect and was associated with improved survival. Further evaluation is warranted.

PMID: 20733135

This extract can be found on http://PubMed.com, and is in the public domain.

On PubMed.com there will be a link to the full paper (often $30, sometimes free).

Any highlighting (except the title) is not by the author, but by Jim Marshall.Jim is not a doctor.