Phase III study of Lucanix fails to meet endpoint in NSCLC

Results from the randomized Phase III trial of Lucanix (belagenpumatucel-L), from NovaRX, find that the primary endpoint of improving overall survival in 532 patients with Non-Small Cell Lung Cancer was not met. However, in the predefined subgroup of 305 stages IIIB/IV patients enrolled within 12 weeks of the completion of frontline chemotherapy, a median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control.

In a predefined subgroup of these patients with squamous cell carcinoma a median survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control. In another predefined subgroup of these patients who received radiation therapy prior to enrollment a median survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control. The endpoint was not met due to patients enrolled more than 12 weeks following the completion of chemotherapy. Data will be presented at the European Society for Medical Oncology 2013 annual meeting in Amsterdam.