AbbVie releases preliminary results from ABT-414 Phase I study in patients with recurrent or unresectable GBM

AbbVie (NYSE: ABBV) released preliminary results from an ongoing Phase I study with ABT-414, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate, in combination with temozolomide, which showed four objective responses, including one complete response, in patients with recurrent or unresectable glioblastoma multiforme. Specifically, one patient experienced a complete response (CR) and three patients experienced partial responses (PR) as measured with the Revised Assessment in Neuro-Oncology (RANO) criteria. These results were presented for the first time at the 50^th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 – June 3 in Chicago.

"Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor, and patients have few treatment options and a five-year survival rate of less than 3 percent," said Gary Gordon, M.D. divisional vice president, oncology clinical development, AbbVie. "We look forward to continuing evaluations of this compound in additional clinical trials."

The Phase I, open-label, multicenter, international trial was designed to evaluate the toxicities, pharmacokinetics and recommended Phase II dose of ABT-414 when administered every other week in combination with temozolomide in patients with recurrent or unresectable glioblastoma. Other important assessments included adverse events, pharmacokinetic parameters, objective response and tumor tissue epidermal growth factor receptor biomarkers.

"ABT-414 is designed to release the effects of the cytotoxic agent once inside targeted cancer cells," said Hui Gan, medical oncologist and senior research fellow at the Austin Health and Ludwig Institute for Cancer Research, Heidelberg, Australia. "The complete response and three partial responses call for further evaluation of this compound in this extremely difficult-to-treat patient population."

Common adverse events (>4 patients) included blurred vision (9 patients), nausea (7 patients), fatigue (6 patients), headache (6 patients), foreign body sensation in the eye (5 patients), photophobia (5 patients), pyrexia (5 patients), corneal deposits (4 patients), eye pain (4 patients) and keratitis (4 patients). Grades 3/4 AEs events (>2 patients) included keratitis (2 patients). Three dose limiting toxicities were reported, including grade 3 corneal deposits.

Later stage clinical trials are being planned to continue to investigate ABT-414 in patients with glioblastoma multiforme.