MM-121: Phase II data
Top-line data from a cohort of NSCLC patients whose disease progressed after EGFR therapy (n=50) in a single-arm, open-label, international Phase II trial showed that MM-121 plus Tarceva erlotinib missed the primary endpoint of a 4-month PFS rate of >=40%. Merrimack declined to disclose details. The trial is also evaluating MM-121 plus Tarceva in 2 other patient cohorts - NSCLC patients with EGFR wild-type tumors who have recurring or progressive disease following >=1 chemotherapy regimen in the metastatic setting and have received no prior EGFR therapy (Group A); and NSCLC patients with a known EGFR-activating mutation who have received no prior EGFR therapy in the metastatic setting (Group B). Merrimack expects to report data from Group A, which will enroll about 120 patients, in 2H13 and from Group B, which will enroll about 70 patients, in 2014. The company said the primary endpoint of both cohorts is PFS, but with different thresholds. ...