Ganymed Pharmaceuticals’ immunotherapy found effective for gastric cancer in Phase II clinical study

Ganymed Pharmaceuticals AG, a biopharmaceutical company developing highly targeted immunotherapies against cancer, announced outstanding data from its randomised Phase II clinical study of IMAB362 in first-line treatment of gastric cancer at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in Chicago.

IMAB362 is a first-in-class monoclonal antibody targeting the cell surface molecule Claudin18.2. 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. Patients with the highest levels of Claudin18.2 had an even longer median overall survival (16.7 months vs 9.0 months).

IMAB362 was well tolerated during the study; most frequent adverse effects were vomiting, nausea and neutropenia.

"Patients diagnosed with advanced gastric cancer currently have a poor prognosis and few available therapeutic options. Results of our study clearly show clinically meaningful efficacy for patients and a favorable risk / benefit profile in this indication of high medical need," said Dr Salah-Eddin Al-Batran, a medical oncologist and director at the Institute of Clinical Cancer Research, Nordwest Hospital in Frankfurt, who presented the data at the ASCO.

"This antibody combines high precision targeting of Claudin18.2 positive tumours with strong immuno-oncological modes of action," said Dr. Özlem Türeci, Co-Founder and CEO of Ganymed. "We are very excited to see that patients in our study benefited very significantly from being treated with IMAB362 with more than twice the number of patients still living at the end of the study after receiving IMAB362 plus chemotherapy compared to chemotherapy alone."

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.

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 per cent of patients with grade 1/2 and 3.6 per cent with grade 3/4 in the control arm versus 55.8 per cent of patients with grade 1/2 and in 10.4 percent with grade 3/4 in the IMAB362 arm) and low blood counts (neutropenia; 21.4 per cent of patients with grade 1/2 and 21.4 per cent with grade 3/4  in the control arm versus 23.4 per cent of patients with grade 1/2 and in 32.5 per cent 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.