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Immunomedics Reports Final Efficacy Results Of Phase Ib Trial With Yttrium-90-Labeled Clivatuzumab Tetraxetan In Patients With Metastatic Pancreatic Cancer

Stocks in this article: IMMU

CHICAGO, June 1, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today reported an overall disease response rate of 41%, including 2 patients (7%) with partial response and 10 patients (34%) with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 ( 90Y), in combination with low-dose gemcitabine as a radiosensitizer. This was compared to a control group of 29 similar patients who received 90Y-clivatuzumab tetraxetan without low-dose gemcitabine. Treatment responses were assessed by computed tomography (CT) based on RECIST criteria.

Results from the multicenter Phase Ib study were presented by Vincent J. Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, at the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO) .

Within the 2 subgroups of patients, adding low-dose gemcitabine extended the median overall survival (OS) for the 29 patients in Arm A to 3.9 months, a statistically significant ( p=0.017) improvement compared with the 2.8 month median OS for the 29 patients receiving only 90Y-clivatuzumab tetraxetan in Arm B.

Furthermore, for patients in Arm A, there were 48%, 34%, 21%, and 10% of patients alive at 3, 6, 9, and 12 months, respectively, indicating that the combination of radiolabeled antibody and gemcitabine improved survival throughout the study.

 
Treatment Number of Patients Survival Results
Arm Enrolled 3 Months 6 Months 9 Months 12 Months
A 29 14 (48%) 10 (34%) 6 (21%) 3 (10%)
B 29 10 (34%) 3 (10%) 1 (3%) 0 (0%)
 

Patients who received multiple cycles of the combination therapy had the best outcome, with a median OS of 7.9 months. This was statistically significant ( p=0.004) compared to the median OS of 3.4 months in patients receiving multiple cycles of 90Y-clivatuzumab tetraxetan only. Additionally, 2 patients in Arm A had a partial response and 2 patients are still alive 13 and 15 months after the start of their combination treatment.

Since patients' response and outcome are expected to deteriorate with each successive round of treatment, these results, obtained from patients who had received at least 2 prior therapies, appear to compare favorably with those from second-line investigational treatment regimens reported at the 2014 ASCO Gastrointestinal Cancers Symposium. 1

The only clinically significant side effect was reduction in platelets, which was transient and manageable.

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