Prima reports response data from Phase IIb of IMP321 in breast cancer
Prima BioMed Ltd. (ASX:PRR; NASDAQ:PBMD) reported additional data from 15 evaluable patients with hormone receptor-positive metastatic breast cancer in the open-label portion of the European Phase IIb AIPAC trial showing that IMP321 plus paclitaxel led to an overall response rate (ORR) of 47%, including 7 partial responses. The disease control rate (DCR) was 87% and included 6 cases of stable disease. Patients received 6 or 30 mg subcutaneous IMP321 on days 2 and 16 of each 4-week cycle plus IV paclitaxel on days 1,8 and 15. Data were presented at the American Society of Clinical Oncology meeting in Chicago.
The double-blind, placebo-controlled portion of the trial is evaluating 30 mg IMP321 every 2 weeks plus weekly paclitaxel in 226 patients with hormone receptor-positive metastatic breast cancer. AIPAC’s primary endpoint is progression-free survival (PFS). Secondary endpoints include safety, overall survival (OS), pharmacokinetics, quality of life (QOL) and ORR...