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Tarextumab granted orphan drug designation for pancreatic, small cell lung cancers
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The FDA granted orphan drug designation to tarextumab for the treatment of pancreatic cancer and small cell lung cancer, the drug’s manufacturer announced today.
Preclinical studies have demonstrated that tarextumab (OMP-59R5, OncoMed) — a fully monoclonal antibody that targets Notch2 and Notch3 receptors — has anti-cancer stem cell activity and affects pericytes that impact the stromal and tumor microenvironment.
“We are excited to receive two separate orphan drug designations for tarextumab for the treatment of pancreatic and small cell lung cancer,” Paul J. Hastings, chairman and CEO of OncoMed, said in a press release. “OncoMed is enrolling patients in two randomized phase 2 clinical trials of tarextumab in pancreatic and small cell lung cancer, and we recently reported promising safety and early efficacy data from our phase 1b studies in these indications.”
Final results from a phase 1b clinical trial indicated that tarextumab was a safe and effective first-line treatment in combination with gemcitabine and paclitaxel (Abraxane, Celgene) for advanced pancreatic cancer. Results showed 21 of 29 (73%) patients achieved a partial response or stable disease with the combination.
Patients with elevated Notch3 expression demonstrated the greatest benefit from the combination. In this cohort, median PFS was 6.6 months and median OS was 14.6 months.
In another phase 1b study designed to evaluate the agent’s efficacy in extensive-stage small cell lung cancer, all 16 patients demonstrated a clinical benefit with first-line tarextumab in combination with etoposide and platinum chemotherapy. Thirteen patients (81.3%) achieved partial responses, and the other three patients demonstrated stable disease.