- Sensitivity for Detection of a Partial Response (PR) was 100% with a 68% Specificity
- Preclinical Results of Combining Clivatuzumab Tetraxetan and Antibody-Drug Conjugate also Reported
Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today reported that a new blood test using the Company's proprietary humanized antibody, clivatuzumab or PAM4, predicted a partial response in an initial set of patients treated with a combination of the antibody labeled with yttrium-90 (Y-90) and gemcitabine. Results were presented at the 101st Annual Meeting of the American Association for Cancer Research.
"We have now demonstrated that the blood assay for PAM4-protein can not only detect early-stage pancreatic cancer, as has recently been reported by us, but may also predict a lack of response to therapy or an early relapse," remarked Cynthia L. Sullivan, President and CEO. "As a result, we believe we may be one step closer to offering an individualized approach for the management of this lethal disease," Ms. Sullivan added.
The challenge in pancreatic cancer is early diagnosis, before the disease has spread and treatment options become limited. To that end, the Company has recently developed a new serum-based enzyme immunoassay (ELISA) employing clivatuzumab that has a sensitivity of 62% for detecting stage-1 pancreatic cancer (disease confined to pancreas), 86% for stage 2 disease, and 91% for stage 3/4 (local and distant spread) cancers. (Please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR01212010.pdf for details of these results). Using the same ELISA test, the current study examined changes in PAM4-protein level in the serum of patients treated with Y90-clivatuzumab, as a means to predict a partial response.
At the recent 2010 ASCO-GI Symposium, the Company reported an overall response rate of 68% with 5 patients having a partial response (PR), 10 with stable disease (SD) and 7 with progressive disease (POD). (For more information on the Phase I/II studies of clivatuzumab as a treatment for patients with pancreatic cancer, please refer to the Company's press release at www.immunomedics.com/news_pdf/2010_PDF/PR01252010.pdf). From this initial group of 22 patients, 17 were evaluable as having both baseline and follow-up sera available for PAM4 testing, of which 4 were PR, 11 patients with SD and 2 patients with POD. Notably, 1 patient was negative for PAM4 in the circulation and excluded from the evaluation.