Cardiff Oncology(US:CRDF)2023-08-15 17:46Clinical Trial Results - The Ph1b/2 trial showed an Overall Response Rate (ORR) of 29% (19 out of 66 patients) for all evaluable patients [12], with a median Duration of Response (mDoR) of 12 months [12] - In Bev Naive patients, the ORR was significantly higher at 73% (11 out of 15 patients) [12], with a mDoR of 13 months [12] - In Bev Exposed patients, the ORR was 16% (8 out of 51 patients) [12], with a mDoR of 89 months [12] - The median Progression-Free Survival (mPFS) for all patients was 93 months [1], while for Bev Naive patients it was 15 months [1] Safety and Tolerability - The trial reported various Treatment-Emergent Adverse Events (TEAEs), with Fatigue being the most common at 72% [2] - Other common TEAEs included Dyspepsia at 43%, Hypocalcemia at 37%, Dehydration and Hypokalemia each at 34% [2] Strategic Direction - The company is advancing its RAS-mutated mCRC program to the 1st line setting, based on FDA agreement [30, 82, 99] - A Phase 2 trial (CRDF-004) is underway for 1st line RAS-mutated mCRC with 90 patients randomized across different treatment arms [32, 87]