Date: 2016-06-05
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Ganymed Pharmaceuticals (Germany)
Product: IMAB362 in combination with epirubicin, oxaliplatin, and capecitabine
Action
mechanism: monoclonal antibody. IMAB362 is a first-in-class monoclonal antibody that is selective and specific for the tight junction protein CLDN18.2. This unique target is present only on differentiated cells of the stomach mucosa and is absent from all other healthy tissues. CLDN18.2 is however expressed in up to 80% of gastrointestinal adenocarcinomas, 60% of pancreatic tumors as well as in subsets of lung, ovarian and bile duct cancers.
Disease: CLDN18.2-positive, advanced, unresectable, recurrent or metastatic gastroesophageal cancer
Therapeutic area: Cancer - Oncology
Country: Bulgaria, Czech Republic, Germany, Latvia, Russian Federation, Ukraine
Trial
details: The randomized three-arm Phase 2 FAST (First-line treatment of patients with CLDN18.2-positive advanced Adenocarcinomas of the STomach, the esophagus or the gastroesophageal junction) clinical trial aims to evaluate the efficacy and safety of IMAB362 in combination with the chemotherapy agents epirubicin, oxaliplatin, and capecitabine (EOX) in 210 patients with CLDN18.2-positive, advanced, unresectable, recurrent or metastatic GEC. CLDN18.2 expression in patients is being determined using Ganymed’s Claudetect™18.2 diagnostic test. The primary endpoints are progression-free survival and safety of IMAB362 in combination with EOX while median overall survival, time to progression, and objective tumor response rate are among the secondary endpoints.(NCT01630083).
Latest
news: * On June 5, 2016, Ganymed Pharmaceuticals announced outstanding data from its randomized Phase 2 clinical study of IMAB362 in first-line treatment of gastric cancer at the ASCO 2016 Annual Meeting. The Phase II study in patients with advanced biomarker-positive gastric cancer reached all its endpoints. As a key finding, IMAB362 significantly extended median overall survival when added to standard chemotherapy (13.2 months vs. 8.4 months, HR 0.51, p=0.0001). Patients with the highest levels of Claudin18.2 had an even longer median overall survival (16.7 months vs 9.0 months, HR 0.45, p<0.0005). IMAB362 was well tolerated during the study; most frequent adverse effects were vomiting, nausea and neutropenia. The study included 161 patients with advanced or recurrent gastric or gastroesophageal junction cancer with a specific minimal level of Claudin18.2 in the tumor. Claudin18.2 levels were assessed from tumor biopsy specimen using the validated CE-marked diagnostic assay Claudetect®18.2. Patients were then randomly assigned to receive standard chemotherapy (epirubicin, oxaliplatin and capecitabine) with IMAB362 (800/600 mg/m2) or chemotherapy alone. Moreover, an additional 85 patients were treated in an added exploratory arm with a higher IMAB362 dose. * On July 22, 2014, Ganymed Pharmaceuticals AG, a biopharmaceutical company developing Ideal Monoclonal Antibodies (IMABs) for the treatment of cancer, announced that it has completed recruitment of 210 patients for its Phase 2 FAST clinical trial to evaluate the combination of IMAB362 and chemotherapy as first-line therapy in patients with gastroesophageal cancer. Top line results from this trial are expected end 2015/early 2016.
Compared to chemotherapy alone, IMAB362 extended the median time to disease progression from 4.8 to 7.9 months (HR 0.47, p=0.0001) and the median overall survival from 8.4 to 13.2 months (HR 0.51, p=0.0001). Among the patients with the highest levels of Claudin18.2, the median overall survival was 16.7 months with IMAB362 and 9 months with chemotherapy alone (HR 0.45, p<0.0005). Treatment with IMAB362 was well tolerated during the study. Vomiting (34.5% of patients with grade 1/2 and 3.6% with grade 3/4 in the control arm versus 55.8% of patients with grade 1/2 and in 10.4% with grade 3/4 in the IMAB362 arm) and low blood counts (neutropenia; 21.4% of patients with grade 1/2 and 21.4 % with grade 3/4 in the control arm versus 23.4% of patients with grade 1/2 and in 32.5% with grade 3/4 in the IMAB362 arm) were slightly more common in the IMAB362 group. The rates of severe adverse effects were not increased with IMAB362 compared to chemotherapy alone.
