Functional profiling using EVA/PCD for prescribing treatment regimens for Stage IV NSCLC improve survival

A team of investigators at Rational Therapeutics, Inc. (http://www.rationaltherapeutics.com) and the Malcolm Todd Cancer Institute (Long Beach, Calif.) has reported that functional profiling using ex-vivo analysis of programmed cell death (EVA/PCD) can be used to prescribe treatment regimens that double the response rate and survival in patients with Stage IV non-small cell lung cancer (NSCLC). The findings of their phase II clinical trial will be presented on Sunday, June 6th at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

“It's not the drugs per se, but rather how they were selected, that changed the outcomes so dramatically. While everyone is talking about 'personalized' cancer treatment, we're doing it.”

Functional profiling provides a real-time window on how human tumors will respond to therapy. By capturing cells within their natural microenvironment, it approximates human biology in the laboratory. NSCLC - the leading cause of cancer death in the US, with little change in survival for decades - offers an ideal target for this approach.

The ASCO study presentation titled, "Phase II Trial of Personalized Chemotherapy In Stage IV NSCLC: Clinical Application Of Functional Profiling In First-Line Therapy" (Abstract No. 7617; Citation: J. Clin Oncol 28:7s, 2010), describes results achieved in patients who received first-line therapy based on their individual ex vivo analyses.

"This method for treating NSCLC allows doctors to optimize the use of existing chemotherapeutics and explore novel therapies in a way that can change the natural history of the disease," said Dr. Nagourney. "What makes the EVA/PCD approach unique is its capacity to capture human tissues in their native state, recapitulating cellular conditions found in the human body."

While the study used only FDA-approved NSCLC drugs, it resulted in a 62 percent response rate - more than double>

"While most cancer researchers explore genomic and proteomic platforms in an effort to 'individualize' treatment, such techniques cannot approach the capacity of functional analyses to examine the complexities and redundancies of human tumor signaling pathways," added Dr. Nagourney. "Yet, it is these cellular signaling pathways that determine clinical response. Experts must be willing to accept that genotype doesn't equal phenotype."

The study prescribed treatments selected among established NSCLC drugs including Gemcitabine, Pemetrexed (Eli Lilly), Paclitaxel, Carboplatin (Bristol Myers), Vinorelbine (Roche) and Erlotinib (Genentech).

While these are the same agents already used widely by oncologists, Dr. Nagourney concluded, "It's not the drugs per se, but rather how they were selected, that changed the outcomes so dramatically. While everyone is talking about 'personalized' cancer treatment, we're doing it."

SOURCE Rational Therapeutics