Chief Scientific and Medical Officer of Symphogen, Ivan Horak, MD, FACP, commented: “I am very pleased to see that the safety profile of this bi-weekly regimen is consistent with previous findings observed with the weekly schedule and the clinical activity of Sym004 in this very difficult to treat patient population with metastatic colorectal cancer, who are resistant to approved anti – EGFR antibodies. This administration schedule offers the potential to combine Sym004 with biweekly chemotherapy regimens used in first and second line therapy of metastatic CRC.”
The ASCO data reports on 29 patients, whose median age was 64 years. Of the 29 patients, 86% had received more than two prior lines of therapy. One cohort of 12 patients was treated at 12 mg/kg and an additional 17 patients were treated at 18 mg/kg of Sym004 Q2W.
No new or unexpected toxicities were identified. Drug-related adverse effects were manageable with dose reduction and supportive medication. In the 12 and 18 mg/kg cohorts, grade 3 skin rash was seen in 4/12 [33%] and 7/17 [41%] patients, respectively (no grade 4), and grade ≥ 3 hypomagnesaemia was seen in 3/12 [25%] and 6/17 [35%] patients, respectively. Grade 3 diarrhea was seen in one patient of each cohort (8%; 6%; no grade 4). Infusion-related reactions were observed in 2/29 (7%) patients (grade 1 and 2, each).
Antitumor activity, measured as disease control (stable disease [SD] + partial response [PR]), was documented in 14/29 (48%) patients.
Sym004 is comprised of two antibodies that are not only designed to block ligand binding, block receptor activation and downstream signaling but are also removal of the EGFR receptors from the cancer cell surface by inducing EGFR internalization and degradation.
For additional information, please contact:
Ivan Horak, MD FACP