OncoMed starts dosing in Phase II trial of lung cancer drug tarextumab

Tarextumab is currently being evaluated in combination with chemotherapy in patients with previously untreated, extensive stage SCLC.

The randomized, placebo-controlled Phase II trial will compare progression-free survival (PFS) outcomes for patients treated with tarextumab administered at 15mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive chemotherapy alone.

In addition, PFS will be evaluated using a predictive biomarker for high tumour Notch3 expression.

According to the company’s scientists, high tumor Notch3 expression is estimated to occur in about 60% of SCLC patients.

The trial’s secondary endpoints include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers.

Around 130 patients are expected to be enrolled in the PINNACLE trial, which is being conducted at about 40 sites in the US.

OncoMed chairman and chief executive officer Paul Hastings said: "We are driving all of our pipeline programs toward advanced clinical read-outs and partner opt-ins.

"This is the second of four randomized Phase II programs expected to begin by late 2014 or early 2015.

"In addition to tarextumab in SCLC and pancreatic cancer, which are both now under way, we are very close to enrolling patients in randomized studies of our anti-DLL4 antibody, demcizumab, in pancreatic and non-small cell lung cancer.

"Our aim is to have multiple randomized Phase II data results between now and by the end of 2016."