Sanofi lung cancer drug fails in late-stage trial
pharmafile | March 11, 2011 | News story | Research and Development | Cancer, NSCLC, Regeneron, Sanofi-Aventis, aflibercept, non-small cell lung cancer
Sanofi-Aventis’ lung cancer drug aflibercept has failed to meet its primary endpoint in a phase III trial.
The late-stage VITAL trial was evaluating the vascular endothelial growth factor receptor trap drug for the second-line treatment of non-small cell lung cancer.
The data showed that adding aflibercept to the chemotherapy drug docetaxel did not meet its primary endpoint of improving in overall survival compared with a regimen of docetaxel alone.
It did meet its secondary endpoints of extending progression free survival, with an overall objective response rate of 23.3% in the aflibercept arm compared to 8.9% in the placebo arm.
Dr Debasish Roychowdhury, head of global oncology at Sanofi, said: “Bringing new and innovative cancer therapies to patients can be incredibly challenging, especially in difficult-to-treat cancers such as second-line non-small cell lung cancer.
“Our phase III trials of aflibercept in metastatic colorectal cancer and hormone-refractory metastatic prostate cancer are underway to determine the clinical potential of aflibercept for patients with these advanced cancers.”
Sanofi and its partner Regeneron said they would conduct a “detailed analysis” of the efficacy and safety results of the VITAL study, which involved 913 patient, with full results to be presented at an upcoming medical meeting.
The VITALtrial also showed a 10% increase in adverse events (AEs) on the aflibercept arm with higher counts of stomatitis, weight decrease, hypertension, epistaxis and dysphonia.
AEs leading to treatment discontinuation occurred in 27.2% of patients in the aflibercept arm compared to 14.6% in the placebo arm.
However, the types and frequencies of AEs reported in the aflibercept treatment arm were generally consistent with those reported in previous studies with anti-VEGF agents.
Current first line treatments for non-small cell lung cancer include AstraZeneca’s Iressa and Roche’s Tarceva and Avastin.
Boehringer Ingelheim is studying its phase III candidate Vargatef as a second line treatment after the failure of Iressa or Tarceva.
Vargatef targets vascular endothelial growth factor receptors (VEGFRs), platelet-derived growth factor receptors (PDGFRs) and fibroblast growth factor receptors (FGFRs).
Ben Adams
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