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Daiichi enrolls first patient in two pivotal phase 3 trials of nimotuzumab

Daiichi Sankyo Company has announced the enrollment of the first patient in two pivotal phase 3 trials of nimotuzumab (DE-766) that is being evaluated as lung cancer and gastric cancer therapeutic.

The recombinant humanized monoclonal antibody nimotuzumab is developed to target the epidermal growth factor receptor (EGFR).

The multicenter, randomized phase 3 trial for lung cancer will enroll around 420 patients with unresectable and locally advanced squamous cell lung cancer in Japan.

Study patients will be randomized with either nimotuzumab plus concurrent chemoradiotherapy or placebo plus concurrent chemoradiotherapy.

The open-label, Japan-Korea collaborative Phase 3 study for gastric cancer (ENRICH study) will enroll 400 patients, previously treated with EGFR overexpressed advanced gastric and gastroesophageal junction cancer, in Japan and South Korea.

Kuhnil Pharmaceutical Company is implementing the ENRICH study in which the subjects will be randomized with either nimotuzumab and irinotecan hydrochloride hydrate combination therapy or irinotecan monotherapy.

Overall survival is the primary endpoint of both the studies while the secondary endpoints include progression free survival and safety.