News Release

Moffitt Cancer Center: Growing interest in prognostic test for non-small cell lung cancer

ERCC1 analysis guides patient treatment decisions

Business Announcement

H. Lee Moffitt Cancer Center & Research Institute

Tampa, FL (April 23, 2010) – Moffitt Cancer Center announces steadily growing interest in the ERCC1 Analysis, the first test developed for selecting chemotherapy for Non Small Lung Cancer patients. Each year, more than 200,000 Americans are diagnosed with lung cancer.

The ERCC1 Analysis measures ERCC1 levels in cells to predict response to cisplatin-based chemotherapy. The correlation between ERCC1 levels and therapy response was discovered at Moffitt Cancer Center and exclusively licensed to Genzyme Corporation in November of 2007. Genzyme Genetics, a business unit of Genzyme Corporation, officially launched the ERCC1 Analysis on May 1, 2009.

Several studies1-6 have shown that evaluating the expression levels of excision repair cross-complementation group 1 (ERCC1) may help physicians identify patients that may benefit from platinum-based chemotherapy - currently considered the standard of care in advanced NSCLC. Specifically, low expression levels of ERCC1 have been related to a better response and survival benefit from adjuvant cisplatin-based chemotherapy.

"We are very pleased that many medical oncologists have begun utilizing this lung cancer test to better identify chemotherapy for non small cell lung cancer patients," said Jarett Rieger, Director of the Office of Technology Management and Licensing at Moffitt. "This test is an example of personalized medicine emanating from Moffitt Cancer Center, and as a result of our licensing partnership with Genyzme this test can now benefit lung cancer patients."

"The ERCC1 test complements our growing menu of personalized tests that predict response to treatment in NSCLC, said Celeste Chenet-Monte, Director Marketing, Oncology at Genzyme Genetics. "Other tests on our menu include EGFR and KRAS mutation analysis, ALK gene rearrangements and EGFR amplification, all of which can be used for prediction of response to targeted therapies used to treat patients with advanced NSCLC."

According to a 5-year retrospective study (n= 389) published in the New England Journal of Medicine, overall survival was significantly longer for patients with ERCC1-negative tumors who had received adjuvant cisplatin chemotherapy when compared to the control group treated by surgery alone (56 months vs 42 months, respectively). Among patients with ERCC1-positive tumors, there was no significant difference in survival between the adjuvant chemotherapy group and the control group (50 months vs 55 months respectively).

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To learn more about Genzyme Genetics ERCC1 Analysis, please visit the website: www.genzymegenetics.com/ercc1

About Moffitt Cancer Center

Located in Tampa, Florida, Moffitt Cancer Center is an NCI Comprehensive Cancer Center - a designation that recognizes Moffitt's excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt currently has 15 affiliates in Florida, one in Georgia and two in Puerto Rico. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer. Moffitt's sole mission is to contribute to the prevention and cure of cancer.

1) Vilmar A, et al. Excision repair cross-complementation group 1 (ERCC1) in platinum-based treatment of non-small cell lung cancer with special emphasis on carboplatin: A review of current literature. Lung Cancer (2008), doi:10.1016/j.lungcan.2008.08.006.

2) Fujii T, et al. ERCC1 predicts the response of cisplatin-based neoadjuvant chemotherapy in non-small-cell lung cancer. Lung Cancer 2007; 08:025.

3) Lord RV, et al. Low ERCC1 expression correlates with prolonged survival after cisplatin plus gemcitabine chemotherapy in non small cell lung cancer. Clin Cancer Res 2002; 8:2286—91.

4) Olaussen K, et al. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 2006; 355:983󈟇.

5) Hwang IG, et al. ERCC1 expression as a predictive marker in stage IIIA, N2 positive non-small lung cancer patients treated with neoadjuvant concurrent chemoradiotherapy followed by surgery. J Thorac Oncol 2007; 2:S367.

6) Reed E. ERCC1 measurements in clinical oncology. N Engl J Med 2006; 355:1054-5.


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