OncoMed Pharmaceuticals, Inc. reported top-line results from the company’s randomized 145-patient Phase 2 PINNACLE clinical trial of tarextumab in combination with etoposide plus either cisplatin or carboplatin chemotherapy (“chemotherapy”) in previously untreated patients with extensive-stage small cell lung cancer. Results for the combination of tarextumab plus chemotherapy were undifferentiated from those of chemotherapy plus placebo, and therefore the trial did not meet its primary endpoint of progression-free survival or secondary endpoints of overall survival and biomarkers reflective of Notch pathway gene activation.
OncoMed also announced that it will discontinue enrollment in the Phase 1b clinical trial of brontictuzumab in combination with trifluridine/tipiracil in third-line colorectal cancer patients. The combination of brontictuzumab plus chemotherapy was not tolerable in this patient population. The median progression-free survival (mPFS) for tarextumab plus chemotherapy was 5.6 months versus 5.5 months for chemotherapy plus placebo (HR=0.969).