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Gastroesophageal Cancer Treatment Shows Promise in Mid-Stage Trial

Antibody reduces disease progression

The monoclonal antibody IMAB362 (Ganymed Pharmaceuticals) has demonstrated safety and therapeutic benefits in a phase IIa trial in patients with gastroesophageal cancer (GEC) who had exhausted all other treatment options.

In the study, 54 patients with CLDN18.2-positive, metastatic, refractory or recurrent advanced GEC received IMAB362 (600 mg/m2) as monotherapy every 2 weeks for five cycles. Final analyses indicated that a partial response and stabilization of disease were achieved after therapy. A per-protocol set of 21 patients showed a disease control rate of 48%. Of these patients, 19% experienced partial remission and 29% achieved a stable disease state, according to the Response Evaluation Criteria in Solid Tumors (RECIST).

The median progression-free survival (PFS) was 102 days (range: 70 to 146 days). Patients with clinical benefits had a median PFS of 262 days compared with 70 days for patients with disease progression. Nine patients continued treatment beyond five cycles because of clinical benefit, and one patient benefited from therapy for more than 16 months.

Nausea and vomiting were the most common drug-related adverse events.

IMAB362 is a first-in-class antibody that is selective and specific for the tight junction protein CLDN18.2. This target is present only on differentiated cells of the stomach mucosa and is absent from all other healthy tissues. CLDN18.2 is expressed in up to 80% of gastrointestinal adenocarcinomas and in 60% of pancreatic tumors, as well as in subsets of lung, ovarian, and bile-duct cancers.

More than a million people worldwide are diagnosed with GEC each year. Most cases are diagnosed at an advanced stage, which reduces the effectiveness of current therapies, resulting in a 5-year survival rate of less than 25%. Major unmet medical needs include the lack of safe and effective systemic first-line therapy, poor control of metastatic tumors, and an absence of second-line treatment options. Consequently, the need for earlier diagnosis and more effective therapies is high.

Source: Ganymed Pharmaceuticals; May 27, 2014.

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