NovaRx Announces Results of Lucanix® Phase III Therapeutic Vaccine Trial for Post-frontline Maintenance Therapy in Non-small Cell Lung Cancer to Be Presented at ESMO.
NovaRx Corporation announced that the detailed results from the randomized Phase III trial of Lucanix® (belagenpumatucel-L) post-frontline maintenance therapy in non-small cell lung cancer will be presented at the European Society for Medical Oncology 2013 annual meeting in Amsterdam. The results will be presented in "Presidential Session I: Best and Late Breaking Abstracts" on 28 September 2013, which starts at 1:45 pm.
The primary endpoint of improving overall survival in 532 patients was not met primarily due to the inclusion of patients more than 12 weeks following the completion of frontline chemotherapy. In this predefined subgroup of 305 stage IIIB/IV patients, a median survival of 20.7 months was observed for Lucanix compared to 13.4 months for the control (HR 0.75). In a the predefined subgroup of these patients with a histology of squamous cell carcinoma a media survival of 20.7 months was observed for Lucanix compared to 12.3 months for the control (HR 0.58). In the predefined subgroup of these patients who received radiation therapy prior to enrollment a media survival of 40.1 months was observed for Lucanix compared to 10.3 months for the control (HR 0.45).