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news.Agennix has reported that the FDA has approved the design of a single, pivotal, Phase III trial evaluating its lead molecule, talactoferrin alfa, in combination with chemotherapy as first-line treatment in patients with non-small cell lung cancer under the special protocol assessment process.
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The Phase III, multinational, randomized, double-blind, placebo-controlled study will enroll 1,100 previously untreated patients with Stage IIIB or IV non-small cell lung cancer (NSCLC). The patients will be randomly assigned to receive up to six cycles of standard chemotherapy (carboplatin and paclitaxel) plus either oral talactoferrin or placebo. Following six cycles of chemotherapy, or discontinuation prior to six cycles for reasons other than progression, patients will receive talactoferrin or placebo as maintenance therapy until disease progression. Progression-free survival and overall survival will be the primary endpoints for accelerated approval and regular approval, respectively. Secondary endpoints include adverse event reductions, confirmed response rate, duration of response and safety.
Agennix also received scientific advice from the European Medicines Agency (EMEA) indicating that this single trial will also support a marketing authorization application in the EU.
Waun Ki Hong, member of Scientific Advisory Board at Agennix, said: “Talactoferrin has the potential to be an important advance in the treatment of NSCLC. I look forward to confirmation of the Phase II results in the Phase III trials.”