Date: 2014-05-31
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 50th American Society of Clinical Oncology (ASCO) Annual Meeting, May 30 to June 3, 2014, in Chicago
Company: AbbVie (USA - IL) Seattle Genetics (USA - WA)
Product: ABT-414
Action mechanism:
Disease: glioblastoma
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On May 31, 2014, Seattle Genetics announced data from several collaborator antibody-drug conjugate (ADC) programs presented at the American Society of Clinical Oncology(ASCO) 50th Annual Meeting being held May 30 to June 3, 2014 in Chicago, IL. AbbVie presented preliminary data from an ongoing phase 1 clinical trial evaluating the ADC ABT-414 in combination with temozolomide in glioblastoma. This program utilizes Seattle Genetics’ ADC technology. A phase 1 study evaluating ABT-414 in combination with temozolomide for subjects with recurrent or unresectable glioblastoma (Abstract #2021, poster presentation Friday, May 30th, 1:00-4:00 p.m. Central Time [CT]) A phase 1 clinical trial is being conducted by AbbVie to evaluate the safety and efficacy of ABT-414 in combination with temozolomide in patients with recurrent or unresectable glioblastoma. ABT-414 is an ADC consisting of a unique antibody targeting epidermal growth factor receptor (EGFR) conjugated to the cytotoxic agent monomethyl auristatin F (MMAF) using Seattle Genetics’ ADC technology. Preliminary results from an ongoing phase 1 clinical trial were reported evaluating the safety, activity and recommended phase 2 dose of ABT-414 when administered every other week in combination with temozolomide. In this preliminary analysis, 21 patients were evaluable for safety and 15 patients were evaluable for efficacy.
ABT-414 in combination with temozolomide demonstrated antitumor activity in the treatment of glioblastoma. In the preliminary analysis, 15 patients with measurable disease at baseline were assessed for best response on study and four patients experienced an objective response, including one complete response and three partial responses. Thirteen patients remained on therapy at the time of data analysis. The recommended phase 2 dose was determined to be 1.25 milligrams per kilogram (mg/kg) in combination with temozolomide. Adverse events of all grades occurring in more than three patients included blurred vision (43 percent), nausea (33 percent) and fatigue and headache (29 percent each). The only Grade 3 or 4 adverse event occurring in more than one patient was keratitis (10 percent). The phase 1 study is ongoing and phase 2 studies are being planned.
