Ligand Pharmaceuticals' shares have fallen close to 29% after its anticancer candidate, Targretin, failed to improve survival rates in two pivotal phase III lung cancer trials.
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The two studies were designed to evaluate whether adding Targretin (bexarotene) capsules to front-line cisplatin/vinorelbine or carboplatin/paclitaxel chemotherapy extends the survival of patients with advanced non-small cell lung cancer (NSCLC).
For both studies, the primary endpoint was overall survival and the secondary endpoint was Kaplan-Meier projected two-year survival. No statistically significant differences in primary or secondary endpoints in the intent to treat population were seen in either trial.
The initial daily dose of Targretin in both trials was similar to that used in prior phase II studies in which a positive trend in survival had been observed.
“We are very disappointed in the lack of survival advantage of Targretin/dual chemotherapy triple therapy in first-line NSCLC patients, particularly in view of the consistent positive trends seen in several phase I/II studies and in the preclinical data that provided strong mechanistic support for a potentially beneficial Targretin/chemotherapy combination,” said Dr Andres Negro-Vilar, Ligand’s executive vice president for R&D and chief scientific officer.
Ligand will continue to analyze the data and plans to continue evaluating Targretin in second- and third-line settings.