The enrolment of the first patient in Phase 1b/2 INvestigation of anti-Notch Antibody therapy with Cisplatin and etoposide in small cell Lung carcinoma Efficacy and safety (PINNACLE) trial will trigger $8m milestone payment from GSK to OncoMed.
PINNACLE trial will 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 and US Oncology Lung Committee developmental Co-Chair and PINNACLE principal investigator Dr. Robert Jotte said, "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."
A Phase 1b dose escalation and expansion phase is followed by a randomized Phase 2 trial designed to compare the efficacy of standard-of-care cisplatin and etoposide either with Anti-Notch2/3 or with placebo.
Progression-free survival in the Anti-Notch2/3 arm compared to a placebo arm in patients who have a particular biomarker is the primary endpoint of the Phase 2 part.
Overall survival, response rate, and safety are 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."