Symphogen's Sym004 misses in Phase II for mCRC

Symphogen A/S (Copenhagen, Denmark) reported data from a Phase II trial in 254 patients with advanced metastatic colorectal cancer (mCRC) and acquired resistance to marketed anti-EGFR mAbs showing that low- and high-dose IV Sym004 each missed the primary endpoint of a 3-month improvement in median overall survival (OS) compared to investigator’s choice of chemotherapy or best supportive care (BSC) (10.3 and 7.9 months, respectively, vs. 9.6 months). Patients in the low-dose Sym004 arm received a 9 mg/kg loading dose followed by once-weekly 6 mg/kg Sym004 and patients in the high-dose Sym004 arm received once-weekly 12 mg/kg Sym004.

In 131 patients with triple-negative mCRC, low- and high-dose Sym004 led to a median OS of 12.8 and 10.6 months, respectively, vs. 7.3 months for investigator’s choice of chemotherapy or BSC. Data were presented at the European Society for Medical Oncology meeting in Madrid. Secondary endpoints in the open-label, international trial include best overall response, progression-free survival (PFS), time to treatment failure, quality of life (QOL), pharmacokinetics and safety...