A phase 2 study of OncoMed Pharmaceuticals' tarextumab in small cell lung cancer has failed to meet its primary and secondary endpoints.
The randomized phase 2 clinical trial, dubbed PINNACLE, featured 145 patients. Tarextumab was administered in combination with etoposide plus either cisplatin or carboplatin chemotherapy in patients who were previously untreated for extensive-stage small cell lung cancer.
The trial’s primary endpoint, which was progression-free survival, was not met as the results from the experimental arm were not different from those who were treated with chemotherapy plus placebo.
OncoMed said the secondary endpoints of the phase 2 trial were also unmet. The secondary endpoints were overall survival and biomarkers which were to reflect activation of the Notch pathway gene.
Following the negative top-line results of the phase 2 trial, OncoMed has also decided to stop enrollment in its phase 1b clinical study of brontictuzumab (anti-Notch1, OMP-52M51) in combination with trifluridine/tipiracil (Lonsurf) in patients with third-line colorectal cancer.
The brontictuzumab plus chemotherapy combination was shown to be intolerable in this patient population.
OncoMed chairman and CEO 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 2 trial.
"We deeply appreciate the participation by the investigators and staff, patients and caregivers who all contributed to the conduct and completion of this Phase 2 clinical trial."
Hastings added that the company will be launching a comprehensive portfolio prioritization review and examine the available data thoroughly along with its resources and the opportunities to re-focus efforts.