Non-Small Cell Lung Cancer (NSCLC)
A randomized Phase II clinical trial is underway to evaluate the efficacy of current standard of care Cisplatin/Pemetrexed with and without CBP501 in the treatment of NSCLC. Participating clinical sites are in the US, Russia, Canada, Argentina, Brazil and Peru. We anticipate completing target enrollment of 192 patients in 2011.
NSCLC accounts for about 80% of all lung cancers and is the leading cause of cancer-related mortality in the US, claiming an estimated 222,520 new cases and 157,300 lives in 2010. The majority of NSCLC cases present at late stage, when survival is less than 10%. While NSCLC has been a focus of many novel drug development programs, molecular targeted therapies have yet to deliver improved efficacy over platinum-based cytotoxic drugs. Results of recent large scale Phase III studies conducted by major pharmaceutical companies on novel molecular targeted compounds in an aggregate of 15,000 NSCLC patients were all negative.
This was predictable because only 5% to 20% of NSCLC patients have the right target mutation for the novel molecular targeted compounds. More than 50% of patients do not show any known mutations in the target molecules. Moreover, even the patient with known mutations can easily develop resistance. Current standard of care chemotherapy continues to be a combination of Cisplatin plus Pemetrexed, the efficacy of which we believe will be significantly enhanced by the addition of CBP501.