AstraZeneca has announced some mixed development news about its new oncology agent Recentin which is moving into late-stage trials for colorectal cancer but has fallen by the wayside in non-small cell lung cancer.
The company noted that its HORIZON III Phase II/III head-to-head study of Recentin (cediranib) with chemotherapy versus Genentech/Roche’s blockbuster Avastin (bevacizumab) with chemotherapy in patients with first line metastatic colorectal cancer will be progressing directly into Phase III at 20mg. However, it had less good news to offer in NSCLC.
AstraZeneca said that the National Cancer Institute of Canada Clinical Trials Group has informed the firm that the BR24 Phase II/III study of Recentin at 30mg in first line NSCLC will not continue into Phase III. This is due to a Phase II efficacy and tolerability analysis by the study’s data safety monitoring committee noting that “although evidence of clinical activity was seen, there appeared to be an imbalance in toxicity”.
John Patterson, AstraZeneca’s executive director for development said that due to the Phase II/III trial design, HORIZON III is able to move directly into late-stage studies “and this saves valuable time in assessing the potential benefit of Recentin in the first line metastatic colorectal cancer setting”. As for the NSCLC indication, he added that “AstraZeneca remains committed to investigating the potential of Recentin in lung cancer and reducing the incidence of serious adverse events”.
The announcement has led to a slight blip in AstraZeneca shares as investors got hold of the news and they had slipped 0.75% at 9.40am. Success as a treatment for NSCLC, a field where there is less competition, would be more lucrative financially than a colorectal cancer indication and analysts are now re-assessing whether Recentin will make it as a blockbuster.
However, shareholders are worried that the Recentin news is another example of AstraZeneca’s recent difficulties in getting drugs to market. Last April saw the late-stage failure of the heart disease treatment AGI-1067, while 2006 saw the termination of an intravenous formulation of AZD7009 for the treatment of atrial fibrillation. Galida (tesaglitazar) for diabetes and blood clot preventer Exanta (ximelegatran) also failed to make the grade and NXY-059 (formerly Cerovive), a candidate drug for stroke, also bombed in a Phase III trial.
