Ipsen has released strong phase II trial data for Cabometyx that compares its new advanced kidney cancer treatment to the standard of care, Pfizer’s Sutent (sunitinib).
The CABOSUN study, presented yesterday at the European Society for Medical Oncology (ESMO) 2016 congress, showed Cabometyx (cabozantinib) can decrease the rate of disease progression or death by 31% in advanced renal cell carcinoma (RCC).
In addition to meeting the primary endpoint of the study, Ipsen and development partner Exelixis said the trial also showed median progression free survival of 8.2 months versus Sutent‘s 5.6 months.
Ipsen and Exelixis will use the findings to pursue new first-line indications in RCC, a prevalent and difficult to diagnose cancer.
David Meek, Ipsen’s chief executive officer, said: “Following the European Commission approval of cabozntinib in second-line advanced RCC, cabozantinib continues to show and expand potential clinical benefit in patients with RCC.
“We look forward to sharing these important data with regulatory authorities and to define the path forward.”
Exelixis’ chief medical Officer Gisela Schwab told a meeting of press and analysts in Copenhagen yesterday that work was underway to prepare the data for submission to the FDA for a supplementary new drug application for Cabometyx. She added that Ipsen was in discussions with the EMA about the next steps for updating its licence in the EU.
Cabometyx was approved by European regulators just last month as a treatment for advanced renal cell carcinoma (RCC) in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy.
Ipsen said then it was hopeful that the once daily oral drug could become a new standard of care in the second line setting of RCC, which represents 2-3% of all cancers, with the highest incidence occurring in western countries.
Meanwhile, the treatment won green light from the FDA in April for its use in the US to treat patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
French biotech Ipsen signed and exclusive licensing agreement with Exelixis in February for the commercialisation and further development of Cabometyx indications outside of the US.