Date: 2014-05-27
Type of information: Results
phase: 2a
Announcement: results
Company: Ganymed Pharmaceuticals (Germany)
Product: IMAB362
Action
mechanism: IMAB362 is a first-in-class 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: gastroesophageal cancer
Therapeutic area: Cancer - Oncology
Country:
Trial
details: This international, multi-center, open-label phase II study aims to establish efficacy and safety of multiple doses of IMAB362 as monotherapy in patients suffering from metastatic, refractory or recurrent adenocarcinoma of the stomach or the lower esophagus. In the trial, patients with CLDN18.(NCT01197885)
Latest
news: * On May 27, 2014, Ganymed Pharmaceuticals announced that its Ideal Monoclonal Antibody IMAB362 demonstrated significant safety and therapeutic benefits in a Phase IIa trial in gastroesophageal cancer (GEC). The trial involved 54 patients who had exhausted all other therapeutic options. In the trial, patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC received 600 mg/m2 IMAB362 as a monotherapy every 2 weeks for 5 cycles. Final analyses indicate that partial response and stabilization of disease was achieved following IMAB362 treatment. A per protocol set of 21 patients showed a Disease Control Rate of 48%: Of these patients, 19% underwent partial remission and 29% achieved stable disease state according to the Response Evaluation Criteria In Solid Tumors (RECIST). The median Progression Free Survival (PFS) was 102 days (95% CI), ranging from 70 to 146 days. Patients with clinical benefits had a median PFS of 262 days as compared to a median PFS of 70 days for patients with disease progression. Nine patients continued treatment beyond 5 cycles due to clinical benefit and one patient has been benefiting from treatment for over 16 months. IMAB362 was safe and well tolerated during the study with nausea and vomiting being the most frequent drug related adverse event. “We are looking forward to seeing the results of the ongoing randomized Phase IIb study that includes 210 patients with gastroesophageal cancer receiving IMAB362 as first-line therapy in combination with chemotherapy. Based on preclinical data a synergistic effect of adding IMAB362 to best standard care is expected, ” said Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed.
