Sanofi-aventis and Regeneron Pharmaceuticals, Inc.  announced data on Saturday 25 June showing that the investigational agent aflibercept, also known as VEGF Trap, significantly improved survival in previously treated metastatic colorectal (bowel) cancer patients.

These data were presented at the ESMO World Congress on Gastrointestinal Cancer in Barcelona, Spain.  Patients with metastatic colorectal cancer (mCRC) previously treated with oxaliplatin were randomized to receive aflibercept or placebo in combination with the FOLFIRI regimen (irinotecan-5-fluorouracil-leucovorin).

The addition of aflibercept to the FOLFIRI regimen significantly improved both overall survival (13.5 months median overall survival vs. 12.06 months in the control arm; HR=0.817; p=0.0032) and progression-free  survival (6.9 months median progression-free survival vs. 4.67 months in the control arm ; HR=0.758;  p=0.00007).

 A similar effect was seen with aflibercept therapy whether or not patients had received prior bevacizumab therapy.

“Velour was an interesting study that recruited patients quickly,” said Dr Rob Glynne-Jones, McMillan Lead GI Cancer, Mount Vernon Centre for Cancer Treatment, Middlesex. He continued “The results are particularly pleasing given the amount of bowel cancer trials in recent years that have failed to meet their endpoints. I am encouraged by these data.”

“We are excited by these results and are committed to bringing this novel therapy to patients as soon as possible,” said Neale Harris, UK Oncology Division Business Director, Sanofi-aventis. “We plan to submit regulatory applications for marketing approval to the European Medicines Agency in the second half of the year.”

He continued “These results highlight the potential use of our novel anti-VEGF therapy in cancer settings where there continue to be significant medical need. We look forward to further developing aflibercept using innovative combinations that can help advance the management of patients with cancer.”

The Velour study was a multinational, randomized, double-blind trial comparing FOLFIRI in combination with either aflibercept or placebo in the treatment of patients with mCRC. The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen.

Approximately 30 percent of patients in the trial received prior bevacizumab therapy. The primary endpoint was an improvement in overall survival. Secondary endpoints included progression-free survival, response to treatment, and safety.

Grade 3 or 4 adverse events (AEs) that occurred with a more than 2 percent greater incidence in the aflibercept arm than in the placebo arm included diarrhoea, asthenia/fatigue, stomatitis/ulceration, infections, hypertension, GI/abdominal pains, neutropenia, neutropenic complications and proteinuria.

Deaths on study treatment due to AEs occurred in 2.6 percent of patients in the aflibercept arm and in 1.0 percent of patients in the placebo arm.

Source: Sanofi-aventis