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Immunomedics Reports First Results From Phase Ib Study Of 90Y-Clivatuzumab In Patients With Metastatic Pancreatic Cancer After 2 Or More Prior Therapies

-- Repeated Cycles of 90 Y-Clivatuzumab Treatments Extended Survival When Compared to Single Cycle -- -- Low-Dose Gemcitabine in Combination with 90 Y-Clivatuzumab Significantly Improved Efficacy of Treatment Regimen -- -- Company Planning Phase III Registration Trial --

BARCELONA, Spain, July 3, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced encouraging results from the Phase Ib study with clivatuzumab labeled with the radioisotope, yttrium-90 ( 90Y), in patients with metastatic pancreatic cancer who had received at least 2 prior treatments. Results from this trial were reported by Edith Mitchell, MD, from the Kimmel Cancer Center of Thomas Jefferson University in Philadelphia, PA, in an oral presentation at the European Society for Medical Oncology (ESMO) 15 th World Congress on Gastrointestinal Cancer.

Clivatuzumab is a humanized antibody developed by the Company for the treatment of pancreatic cancer. It targets a specific tumor marker produced by almost all pancreatic cancers that is not usually present in pancreatitis, normal pancreas or most other normal tissues. The Company has previously reported a median overall survival (OS) of 11.8 months in patients with newly diagnosed, untreated, advanced pancreatic cancer after receiving repeated cycles of the 90Y-labeled antibody in combination with low-dose gemcitabine. 1

The current Phase Ib study of clivatuzumab was undertaken in pancreatic cancer patients with two or more prior therapies. For these relapsed patients, there is no agreed standard-of-care, and options for further therapy are limited. Clivatuzumab may offer an attractive alternative, especially for those patients with adequate performance status who are unable or unwilling to accept the side effects of additional chemotherapy. The objective of this multicenter trial was to evaluate the safety, tolerability, and evidence of efficacy of the 90Y-labeled-clivatuzumab treatment regimen in previously-treated patients with metastatic pancreatic cancer, and to determine the contribution of low-dose gemcitabine to the treatment regimen.

A total of 58 patients were randomized to receive either 90Y-labeled-clivatuzumab once-a-week for 3 weeks at 6.5 mCi/m 2 with gemcitabine 200 mg/m 2 given weekly x 4 weeks (Arm A) or 90Y-labeled-clivatuzumab alone (Arm B). This treatment cycle was repeated every 4 weeks until unacceptable toxicity, patient deterioration or patient withdrawal. Patients were followed for one year or until death. The median age of these patients was 65, with a median of 1.6 years from initial diagnosis, and a median of 3 (2-6) prior treatments.

Results from 53 patients who completed at least one treatment cycle were presented. The median overall survival (OS) for Arm A ( 90Y-labeled-clivatuzumab with low-dose gemcitabine, N=27) was 119 days, a significant improvement over Arm B ( 90Y-labeled-clivatuzumab alone, N=26), with a median OS of 80 days (P=0.04). Furthermore, for the 23 patients who received multiple cycles of therapy, the median OS increased to 157 days in Arm A compared with 103 days in Arm B.

Survival was also related to patients' Karnofsky Performance Status (KPS) scores at study entry, increasing from a median of 79 days for patients with 80% KPS to 119 days for patients with 90-100% KPS. In contrast, increased number of prior treatments is a negative prognostic indicator for survival. The median OS decreased from 90 to 82 to 73 days for patients who received 2, 3, or 4-5 prior treatments, respectively.

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