Custirsen Shows Promise For Advanced Non-small Cell Lung Cancer

Editor's Choice
Academic Journal
Main Category: Lung Cancer
Also Included In: Cancer / Oncology
Article Date: 06 Jan 2012 - 9:00 PST


Data assessing custirsen (OGX-011/TV-1011), an investigational compound, in individuals with advanced non-small cell lung cancer (NSCLC) were published online in the January 2012 issue of the Journal of Thoracic Oncology, OncoGenex Pharmaceuticals, Inc. announced January 4th.

Results from the trial provide further clinical evidence of the potential of custirsen, a medication developed to prevent clusterin generation. Clusterin is a cell survival protein frequently over-produced in many types of cancer.

The single-arm trial was carried out at 15 locations in North America. The team assessed custirsen treatment in conjunction with a gemcitabine/platinum-based regimen in individuals with previously untreated, advanced NSCLC. At least one dose of custirsen was given to 81% of the participants who were included in the initial examination.

Vital findings from the investigation include:

• The one year survival rate was 54% and the rate of two-year survival was 30%. At a median follow-up of 41 months (range 38-59 months), 12% of patients were still alive.
• 31% of participants had tumor responses defined as complete or partial responses, while 69% of participants had a clinical response defined as stable disease or objective response.
• 14.1 months was the median overall survival, while progression-free survival was 4.3 months.
• In 95% of participants assessed, custirsen treatment lowered serum clusterin levels. Furthermore, participants who reached a threshold minimum serum clusterin level of < / = 45 mcg/mL had a median survival of 27.1 months in comparison to 15.6 months for participants who did not achieve this level.

According to the researchers, survival data in this study compared quite favorably with published data of individuals receiving a gemcitabine/platinum-based regimen in a comparable regimen and dose, with median survivals of around 7 to 11 months. In addition, the team concluded that toxicity of the combination did not significantly differ from previously reported gemcitabine/platinum combinations.

Dr. Janessa Laskin, a medical oncologist at the British Columbia Cancer Center and lead researcher of the investigation said:

"The identification and targeting of new therapeutic pathways, such as clusterin inhibition, are required in order to improve outcomes for cancer patients.

The data reported in this clinical trial warrant the need to further evaluate custirsen in a randomized, Phase III study in advanced lung cancer."

Lung cancer is the primary cause of cancer-related death. In 2012, in the U.S., roughly 220,000 individuals will be diagnosed with lung cancer. This year, plans are in motion for OncoGenex and Teva to start a Phase III clinical trial of custirsen in non-small cell lung cancer.

About Custirsen

Custirsen is an investigational medication designed to inhibit the generation of clusterin, a protein that, when over-produced, can be linked to tumor cell survival. This can result in faster rates of disease progression, lower survival rates in several types of cancer, as well as resistance to treatment.

In Phase I and Phase II clinical trials, 297 individuals with different types of cancer received custirsen. The majority of participants experienced one or more side effects. Some of the adverse events were the result of either the disease itself or additional treatments in the protocol.

The majority of side effects were mild and those frequently linked to custirsen consisted of flu-like symptoms. 25% (74 participants) experienced serious adverse events (SAEs). The researchers believed that the SAEs for 36 participants (12%) were possibly, probably, or definitely associated to study treatment (chemotherapy in conjunction with custirsen). In 2% of participants, the most prevalent SAEs connected with custirsen were pyrexia, dyspnea, pleural effusion, and febrile neutropenia.

Written by Grace Rattue
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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