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Trials & Filings

Lucanix Misses NSCLC Endpoint

Subgroups with early treatment fare better

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Phase III trial of NovaRx Corp.‘s Lucanix (belagenpumatucel-L) missed the primary endpoint of improving overall survival in 532 patients with non-small cell lung cancer (NSCLC). There were positive results in a prominent.

In the predefined subgroup of 305 stage 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.

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