US-based OncoMed Pharmaceuticals' tarextumab (anti-Notch2/3, OMP-59R5) has not met the endpoints in a Phase II clinical trial to treat patients with extensive-stage, small-cell lung cancer.

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Tarextumab is a fully human monoclonal antibody designed to target the notch2 and notch3 receptors.

The trial's top-line results showed that tarextumab has not met the primary endpoint of progression-free survival or secondary endpoints of overall survival and biomarkers related to notch pathway gene activation.

The randomised, double-blinded, multi-centre Phase II PINNACLE trial evaluated the combination of 15mg/kg of tarextumab with etoposide and either cisplatin or carboplatin chemotherapy in 145 patients at 36 sites within the country.

"Small-cell lung cancer is a very difficult-to-treat disease and unfortunately, tarextumab did not show benefit over placebo in this Phase II trial."

OncoMed chairman and chief executive officer Paul Hastings said: "Small-cell lung cancer is a very difficult-to-treat disease and unfortunately, tarextumab did not show benefit over placebo in this Phase II trial.

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"We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and completion of this Phase II clinical trial."

It was found that the median overall survival (mOS) analysis did not indicate any favourable outcome for tarextumab and chemotherapy combination, when compared to the combination of chemotherapy and placebo.

The firm also plans to discontinue recruiting patients in the Phase Ib clinical trial of brontictuzumab (anti-Notch1, OMP-52M51) in combination with trifluridine / tipiracil (Lonsurf) for the treatment of patients with third-line colorectal cancer, as the combination was found to be intolerable.

Image: Micrograph of small-cell lung cancer. Photo: courtesy of Nephron/Wikipedia.

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