Ganymed’s IMAB362 Shows Strong Evidence of Single-Agent Activity in Phase IIa Trial in Gastroesophageal Cancer

Ganymed Pharmaceuticals AG has 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.

“This study establishes IMAB362’s high potential as novel treatment for patients with advanced gastroesophageal cancers,” commented Professor Martin Schuler, West German Cancer Center, Essen, who coordinated the study. “The clinical activity seen in this heavily pretreated study population is very promising for an antibody monotherapy.”

In the trial, patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC (NCT01197885) received 600 mg/m2 IMAB362 as a monotherapy every 2 weeks for five 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 five cycles due to clinical benefit and one patient has been benefiting from treatment for more than 16 months.

IMAB362 was safe and well tolerated during the study with nausea and vomiting being the most frequent drug related adverse event.

“I find it exciting that even as single agent, IMAB362 brought therapeutic benefits to patients to whom we have no other therapeutic options to offer,” said Professor Emeritus Christoph Huber, Co-founder and Supervisory Board member of Ganymed. “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.”