There's been both good and bad news in cancer drug development this week. A phase 3 trial of the first targeted drug for squamous non–small cell lung cancer (NSCLC), necitumumab (under development by Eli Lilly) was successful, but another phase 3 trial investigating a novel immunotherapeutic in melanoma has failed.
Necitumumab met its primary endpoint in a phase 3 trial conducted in patients with stage 4 metastatic squamous NSCLC, Lilly announced.
When the drug was added to the chemotherapy doublet of gemcitabine and cisplatin, it improved overall survival compared with that seen with chemotherapy alone. The data will be presented at a scientific meeting next year, and the drug will be submitted for approval by the end of 2014.
The most common adverse events seen with necitumumab were rash, hypomagnesemia, and thromboembolism, the company said.
The failed phase 3 trial in melanoma was studying the investigational immunotherapeutic velimogene aliplasmid (Allovactin, under development of Vical Inc).
The product, which contained a plasmid expressing 2 immune-stimulating genes, HLA-B7 and β2 microglobulin, was designed to stimulate both innate and adaptive immune responses in local tumors and distal metastases.
However, results from the trial, which involved 390 patients, showed no improvement when compared with chemotherapy either in overall survival or in reducing tumor size. The product has now been dropped from development, the company said.
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