Oncogenex makes SATURN trial of custirsen (OGX-011) more accessible

The Phase III SATURN clinical trial of OGX-011 in treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) after initial chemotherapy with docetaxel + prednisone required men to be randomized to either docetaxel + prednisone + OGX-011 or to docetaxel + prednisone + a placebo.

The original primary objective of the SATURN trial was to ascertain whether docetaxel + prednisone + OGX-011 was better at palliating durable pain in men with mCRPC compared to docetaxel + prednisone + a placebo.

After discussions with the U.S. Food & Drug Administration (FDA), OncoGenex has announced today that the company has been able to expand the inclusion criteria for the SATURN trial such that eligible patients may now be randomized to treatment with either docetaxel or cabazitaxel + prednisone + OGX-011 or docetaxel or cabazitaxel + prednisone + a placebo. All other aspects of the study design are unchanged; all patients must have stable pain at study entry.

Dr. Tomasz Beer, one of the principal investigators for the SATURN trial, is quoted in the company media release as saying:

Until recently, docetaxel was the only standard of care for chemotherapy treatment of mCRPC with a demonstrated survival benefit. With the recent approval of cabazitaxel for mCRPC treatment after docetaxel, men have a new option that extends survival.  In an effort to improve the palliative benefits of this new treatment, we are evaluating custirsen with cabazitaxel for pain palliation. Pain palliation in patients treated with cabazitaxel was reported at 9.2% and pain is one of the most common and devastating consequences of very advanced prostate cancer.

Clearly the ability to prevent pain in men after failure of chemotherapy to prevent disease progression remains a critical clinical objective for patients with mCRPC. At this time, mitoxantrone + prednisone remains the only form of chemotherapy actually approved for the management of pain in men with mCRPC.

A separate Phase III clinical trial (the SYNERGY trial) is also evaluating the ability of docetaxel + prednisone + OGX-011 (compared to docetaxel + prednisone + a placebo) to extend the survival of men with mCRPC previously treated with docetaxel + prednisone.

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