The HORIZON Independent Data Monitoring Committee (IDMC) conducted a planned end of Phase II (EOP II) review of efficacy and tolerability data from HORIZON I, HORIZON II and HORIZON III. Data from HORIZON I, in second line colorectal cancer, would not by itself have contributed to a positive EOP II decision. However, when combined with a review of data from HORIZON II and III by the IDMC, the IDMC confirmed the HORIZON programme in 1st line CRC could continue and HORIZON II and III had met pre-defined EOP II criteria.
AstraZeneca today 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.
In addition to colorectal and non-small cell lung cancer, the RECENTIN development programme includes trials in recurrent glioblastoma and a number of signal search studies in other tumours.
John Patterson, AstraZeneca's Executive Director for Development, said: "Given there is such a high unmet patient need for more effective treatments in cancer, we are pleased that the HORIZON colorectal cancer programme has met its pre-defined criteria to continue recruitment into Phase III. 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.
"AstraZeneca supports the NCIC-CTG's BR24 recommendation and is working with them to understand the data more fully in NSCLC. As evidence of clinical activity was seen in BR24, AstraZenenca remains committed to investigating the potential of RECENTIN in lung cancer and reducing the incidence of serious adverse events."
RECENTIN™ is a trademark of the AstraZeneca group of companies.
AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For further ifnormation, visit www.astrazeneca.com.