06 Jun 2013, BioSpectrum Bureau , BioSpectrum
Singapore: Bionomics presented an update on its renal cancer candidate's (BNC105) clinical trial program at the annual American Society for Clinical Oncology (ASCO) meeting in Chicago, US. The trial is a multinational, multi-center phase I/II clinical trial of BNC105 in combination with everolimus (Afinitor) in patients with progressive metastatic renal cell carcinoma that have previously progressed on treatment with tyrosine kinase inhibitors.
Afinitor is an mTOR inhibitor used as a treatment after patients have failed therapy with tyrosine kinase inhibitors such as Sutent. Afinitor, approved by the US FDA for the treatment of renal cancer in 2009 and marketed by global pharma company Novartis, clocked sales of $700 million in 2012.
The poster was presented by Dr John Sarantopoulos, Institute for Drug Development Cancer Therapy and Research Center, University of Texas Health Science Center, San Antonio, US. It provided an update and additional data from the phase I component of the trial.
Phase I data are indicative of clinical benefit and sustained therapy, with patients staying on therapy for up to 18 months. The combination of BNC105 and Afinitor is well tolerated with no dose limiting toxicities or evidence of cumulative toxicity. Eight-of-the-12 patients achieved disease stabilization.
The median treatment period across these eight patients was 11 cycles. Dose related changes in biomarkers indicative of vascular response suggest that BNC105 reaches plasma levels of pharmacological significance. The phase II component of the study is ongoing at 77 US, Australian and Singaporean clinical trial sites.