Methodology & Results
- This was a multi-arm Phase 1 study in which MM-111 was combined with commonly used HER2-targeting regimens. Each arm of the study ran as a separate Phase 1 using standard 3+3 dose escalation. Safety, Tolerability, PK and responses were evaluated.
- A total of 46 patients with documented advanced HER2 + cancer received weekly doses of MM-111 at 10 mg/kg and escalated up to 20 mg/kg.
- MM-111 was tolerable and could be safely combined at full dose with lapatinib / trastuzumab and paclitaxel / trastuzumab regimens. The capecitabine containing arm required dose reduction of capecitabine. Re-escalation of MM-111 is ongoing.
- The toxicity profile of the MM-111 combinations was consistent with that generally observed in patients receiving the underlying HER2 therapy.
- Across all dosing regimens, the overall clinical benefit rate, defined as complete response (CR), partial response (PR) and stable disease (SD) for at least 4 months, was 52 percent in 29 evaluable patients.
- Responses were observed across various tumor types including, breast, bladder, esophageal, colorectal and ovarian cancers.