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Phase 1/2 Trial OXG-011 in NSCLC/Update 2-Year Survival Data


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Excerpt from ARTICLE:

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OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced the two-year survival rate from a Phase 1/2 clinical trial of OGX-011 in combination with first-line chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC). At two years, 30% of patients who had received OGX-011 with first-line chemotherapy were alive. OncoGenex has previously reported a mature median survival of 14.1 months and a one-year survival rate of 54%.

For comparison, published studies using a platinum-based regimen plus gemcitabine as first-line chemotherapy for advanced NSCLC reported median survivals of 8 to 11 months and one-year survival rates of 33% to 43%. Market approval for Avastin plus paclitaxel and carboplatin chemotherapy for NSCLC was based on results showing a median survival of 12.3 months compared to 10.3 months for patients treated with chemotherapy alone. Survival rates for Avastin plus chemotherapy versus chemotherapy alone were reported as 51% versus 44% at one year and 23% versus 15% at two years, respectively.

"The two-year survival rate of 30% in our Phase 1/2 NSCLC study compares favorably to the survival reported for Avastin plus paclitaxel and carboplatin chemotherapy," said Scott Cormack, president and CEO of OncoGenex. "These data remain consistent with our Phase 2 data in prostate cancer suggesting that OGX-011 when added to chemotherapy may improve survival by blocking the production of clusterin, the protein associated with treatment resistance in various cancers."

This single-arm, open-label study enrolled 81 patients with Stage IIIB (18 percent) or Stage IV (82 percent) NSCLC who were treated with OGX-011 in combination with a standard first-line NSCLC chemotherapy regimen that included a platinum-based regimen plus gemcitabine. 51% of patients had adenocarcinoma, 16% had squamous cell carcinoma and 33% of patients had undifferentiated or unspecified non-small cell lung cancer. The primary objectives of the study were designed to estimate objective response rates of OGX-011 in combination with a gemcitabine/platinum-based regimen, establish the recommended dose of OGX-011, and determine the safety and tolerability. Secondary objectives were aimed to estimate the progression-free survival, overall survival, the pharmacokinetic profile of OGX-011, and the effect of OGX-011 on serum clusterin levels.

69% of patients experienced disease control (complete response =1%, partial response =30%, stable disease =38%), 26% experienced disease progression, and response was not assessable in 5%. Median progression-free survival was 4.6 months (0.06 - 17.7 months). Investigators concluded that the treatment with OGX-011 was generally well tolerated, and toxicities were consistent with the adverse event profile for gemcitabine in combination with a platinum-based regimen in this population.

Serum clusterin analysis for this NSCLC study showed that OGX-011 treatment significantly decreased the mean average serum clusterin levels during treatment when compared to baseline levels (p (less than) 0.0001) and that achieving low average serum clusterin levels during treatment correlated with improved survival (p=0.012).

About OGX-011

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance and is currently being evaluated in Phase 2 clinical studies in prostate, lung and breast cancer. Recently, OncoGenex Pharmaceuticals announced that OGX-011 showed an overall survival advantage in a randomized, controlled Phase 2 Study in first-line treatment of metastatic castrate resistant prostate cancer, in which the median survival for patients receiving OGX-011 in combination with docetaxel and prednisone was 27.5 months, compared to 16.9 months in patients receiving docetaxel and prednisone alone. At the 2008 Annual Meeting of the American Society of Clinical Oncology meeting, OncoGenex reported OGX-011 Phase 2 data in second-line treatment of metastatic castrate resistant prostate cancer showing better than expected survival results in combination with chemotherapy, reduction in levels of clusterin, durable reductions in pain, and a decline in PSA, a protein that is often elevated in patients with prostate cancer.

Based on clinical results to date, OncoGenex intends to conduct Phase 3 registration studies with OGX-011 in metastatic castrate resistant prostate cancer, subject to the receipt of additional funding. The U.S. Food & Drug Administration (FDA) has agreed on the design of one Phase 3 registration trial in combination with second-line chemotherapy investigating overall survival as the primary endpoint via the Special Protocol Assessment (SPA) process. In addition, the FDA has confirmed that durable pain palliation is an acceptable primary endpoint for a registration trial in metastatic castrate resistant prostate cancer. OncoGenex intends to obtain an agreement with FDA on the design of a second Phase 3 registration trial featuring pain palliation via the SPA process. OGX-011 has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.

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(Medical News Today, Lung Cancer; Cancer/Oncology, February 8, 2009 [Contains Forward-Looking Statements])


The information contained in these articles may or may not be in agreement with my own opinions. They are not being posted with the intention of being medical advice of any kind.

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