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news.US-based biopharmaceutical firm Exelixis has reported positive results from a Phase II clinical trial (Study E1512) evaluating cabozantinib to treat EGFR wild-type non-small cell lung cancer (NSCLC).
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Conducted by the ECOG-ACRIN Cancer Research Group as part of Exelixis’ collaboration with the US National Cancer Institute (NCI), the Study E1512 is a randomized phase II trial of cabozantinib and erlotinib, alone or in combination, as second- or third-line therapy in patients with metastatic EGFR wild-type NSCLC.
The company said that the Phase II trial met its primary endpoint, showing significant increases in progression-free survival (PFS) for cabozantinib and the combination of cabozantinib plus erlotinib when individually compared to the erlotinib arm.
ECOG-ACRIN group co-chair Robert Comis said: "Despite the availability of new therapies, lung cancer continues to pose significant clinical challenges.
"The magnitudes of improvement in progression-free survival and overall survival delivered by the combination and single agent cabozantinib arms in this randomized phase II trial are encouraging, and they provide a strong rationale for further evaluation of cabozantinib in non-small cell lung cancer."
Exelixis president and chief executive officer Michael Morrissey said: "Exelixis is committed to working with our partners at ECOG-ACRIN and the National Cancer Institute to evaluate that potential, and we look forward to discussing possible next steps, including combination trials with immunotherapies, as well as potential pivotal studies in late-line disease."
The median PFS for the combination of cabozantinib and erlotinib was 4.7 months versus 1.9 months for erlotinib alone, while the median PFS for cabozantinib monotherapy was 4.2 months versus 1.9 months for erlotinib alone.
A total of 125 patients with metastatic EGFR wild-type NSCLC who had received at one or two prior chemotherapy regimens were enrolled in the trial and they were randomized 1:1:1 to receive erlotinib (150mg daily), cabozantinib (60mg daily), or the combination of erlotinib plus cabozantinib (150mg plus 40mg daily).
Earlier, the company had reported positive top-line results from this trial in November 2014.