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ARTICLE | Clinical News

MM-111: Phase I data

October 15, 2012 7:00 AM UTC

Data from 29 evaluable patients in an open-label, dose-escalation, U.S. Phase I trial showed that once-weekly MM-111 in combination with chemotherapy led to a clinical benefit rate (CBR) of 52%. Specifically, MM-111 plus cisplatin, capecitabine and trastuzumab produced 11 complete responses (CR), 2 partial responses (PR) and 9 cases of stable disease (SD). MM-111 plus lapatinib and trastuzumab produced 2 PRs. MM-111 plus paclitaxel and trastuzumab produced 4 PRs and 5 cases of SD. MM-111 was initiated at a dose of 10 mg/kg and was safely escalated up to a dose of 20 mg/kg when combined with full doses of lapatinib-, trastuzumab- and paclitaxel-based therapies. However, MM-111 required dose reduction to 5 mg/kg when given in combination with cisplatin, capecitabine and trastuzumab. Dose-limiting toxicities (DLTs) included myelosuppression, infection, vomiting, diarrhea, mucositis, hypokalemia, hyponatremia, hypophosphatemia, hyperuricemia and a report of congestive heart failure (CHF). Serious adverse events reported included pneumothorax, confusion, hemiparesis, seizure, sepsis, diarrhea, disease progression and CHF. Responses were seen in various tumor types including breast, bladder, esophageal, colorectal and ovarian cancer. Data were presented at the European Society for medical Oncology meeting in Vienna. ...