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Phase 2 trial of tarextumab for small cell lung cancer fails to meet primary, secondary endpoints
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A phase 2 trial designed to evaluate tarextumab for the treatment of small cell lung cancer failed to meet its primary and secondary endpoints, according to the drug’s manufacturer.
Tarextumab (anti-Notch2/3, OMP-59R5; OncoMed) is a fully human monoclonal antibody that targets the Notch2 and Notch3 receptors.
“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,” Paul Hastings, chairman and CEO of OncoMed, said in a company-issued press release. “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.”
The randomized phase 2 PINNACLE trial evaluated tarextumab in combination with etoposide plus cisplatin or carboplatin chemotherapy in 145 patients previously untreated for extensive-stage small cell lung cancer.
PFS served as the primary endpoint. Secondary endpoints included OS and biomarkers that were to reflect activation of the Notch pathway gene.
Patients treated with tarextumab plus chemotherapy demonstrated no significant benefit in median PFS (5.6 months vs. 5.5 months) or overall response rate (68.5% vs. 70.8%) compared with those assigned placebo.
In another development, OncoMed discontinued enrollment of its phase 1b trial of brontictuzumab (anti-Notch1, OMP-52M51; OncoMed) in combination with trifluridine/tipiracil (Lonsurf, Taiho Oncology) in patients with third-line colorectal cancer. The combination appeared intolerable among the patient population, according to the press release.