AstraZeneca also announced that the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) has informed AstraZeneca that the BR24 Phase II/III study of Recentin at 30mg in first line non-small cell lung cancer (NSCLC) will not continue into Phase III following the planned end of Phase II efficacy and tolerability analysis by the study’s Data Safety Monitoring Committee. Although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity and therefore the study was considered not to have met the pre-defined criteria for automatic continuation into Phase III. AstraZeneca is working in close collaboration with the NCIC-CTG to understand the BR24 data further.
Patients will continue to be recruited at 20mg into the first line CRC Horizon II study of Recentin with chemotherapy versus chemotherapy alone. In addition to colorectal and non-small cell lung cancer, the Recentin development program includes trials in recurrent glioblastoma and a number of signal search studies in other tumours.
John Patterson, executive director for development, AstraZeneca, said: “Due to the Phase II/III trial design, Horizon III is able to move directly into Phase III utilising all the Phase II data and this saves valuable time in assessing the potential benefit of Recentin in the first line metastatic colorectal cancer setting.