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GEN News Highlights : Aug 13, 2013

Lilly Phase III Candidate Meets Primary Endpoint of NSCLC Overall Survival

Officials at Eli Lilly say that SQUIRE, a recently completed Phase III study, met its primary endpoint. The trial found that patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC) experienced increased overall survival when administered necitumumab (IMC-11F8) in combination with gemcitabine and cisplatin as a first-line treatment, as compared to chemotherapy alone.

The most common adverse events occurring more frequently in patients on the necitumumab arm were rash and hypomagnesemia. Serious, but less frequent, adverse events occurring more often on the necitumumab arm included thromboembolism.

“If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer,” noted Richard Gaynor, M.D., vice president, product development and medical affairs for Lilly Oncology.

This is good news for Lilly, who have encountered multiple Phase III failures over the past year including the halted Phase III PRELUDE study back in May, which assessed the drug candidate enzastaurin as a monotherapy in the prevention of relapse in patients with diffuse large B-cell lymphoma (DLBCL). Enzastaurin reportedly failed to show a statistically significant increase compared to placebo in disease-free survival in patients at high risk of DLBCL relapse following rituximab-based chemotherapy.