OncoMed Pharmaceuticals has initiated a Phase Ib/II trial of anti-cancer stem cell therapeutic OMP-59R5 (Anti-Notch2/3) in small cell lung cancer (SCLC).
The enrolment of the first patient in the Phase Ib/II Pinnacle trial will trigger an $8m milestone payment from GSK, OncoMed's strategic collaborator.
The Pinnacle trial is designed to assess Anti-Notch2/3 in combination with cisplatin and etoposide in first-line extensive-stage SCLC patients.
Rocky Mountain Cancer Centers in Denver, Colorodo, medical oncologist, US Oncology Lung Committee developmental co-chair and trial principal investigator Dr Robert Jotte said Anti-Notch2/3 works by a novel anti-cancer stem cell mechanism to treat patients with small cell lung cancer.
"This disease is an aggressive form of cancer where patients are in need of new treatment options. We hope Pinnacle yields important data for these patients," Jotte said.
After a Phase Ib dose escalation and expansion phase, a randomised Phase II clinical trial will compare the efficacy of standard-of-care cisplatin and etoposide either with Anti-Notch2/3 or with placebo.
Progression-free survival (PFS) in the Anti-Notch2/3 arm compared to placebo in patients who have a particular biomarker will be the primary endpoint of Phase II.
Overall survival, response rate and safety will be the secondary and exploratory endpoints.
OncoMed president and chief executive officer Paul Hastings said; "We have now initiated two proof-of-concept trials for our novel Anti-Notch2/3 antibody in the high un-met medical need indications of small cell lung cancer and pancreatic cancer."
In 2012, OncoMed initiated the antibody therapy in first-line pancreatic cancer investigating anti-notch efficacy and safety (Alpine) trial in first-line advanced pancreatic cancer patients.
The Anti-Notch2/3 (OMP-59R5) Phase 1b/2 Alpine trial has now been amended to include gemcitabine and abraxane chemotherapy.
Image: Histopathogic image of pancreatic adenocarcinoma arising in the pancreas head region. Photo: KGH.