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SQUIRE: Necitumumab improved OS in stage IV NSCLC
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The addition of necitumumab to gemcitabine and cisplatin as a first-line treatment extended OS compared with chemotherapy alone among patients with stage IV metastatic squamous non–small cell lung cancer, the drug’s manufacturer announced.
The recently completed phase 3 SQUIRE trial assessed the efficacy necitumumab (IMC-11F8, Eli Lilly), an investigational anti-epidermal growth factor receptor antibody, as a treatment for advanced NSCLC. The trial included 1,093 patients.
The most common adverse events among patients who received necitumumab were rash and hypomagnesemia. Serious but less frequent adverse events that occurred more frequently in patients assigned to necitumumab included thromboembolism.
“We are pleased with these data, which represent a potential advance in treatment for patients with squamous non–small cell lung cancer, which is a difficult cancer to treat,” Richard Gaynor, MD, vice president of product development and medical affairs for Lilly Oncology, said in a press release. “If approved, necitumumab could be the first biologic therapy indicated to treat patients with squamous lung cancer.”
Lilly plans to present results from the SQUIRE trial at a scientific meeting in 2014 and expects to submit to regulatory authorities before the end of next year, according to the release.