Aflibercept Significantly Improves Survival In Previously Treated Metastatic Colorectal Cancer Patients
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.1 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).1 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).1 A similar effect was seen with aflibercept therapy whether or not patients had received prior bevacizumab therapy.1
“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.1 The study randomized 1,226 patients with mCRC who previously had been treated with an oxaliplatin-based regimen.1 Approximately 30 percent of patients in the trial received prior bevacizumab therapy.1 The primary endpoint was an improvement in overall survival.1 Secondary endpoints included progression-free survival, response to treatment, and safety.1 GB.ONC.11.06.06
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.1
About the Aflibercept Clinical Development Programme
Sanofi Oncology and Regeneron are collaborating on a broad oncology development programme, combining the investigational agent aflibercept with common chemotherapy regimens in the treatment of patients with advanced cancers. In addition to VELOUR, the programme includes one Phase III trial and one Phase II trial, both of which are fully enrolled: – VENICE: First-line treatment for hormone-refractory metastatic prostate cancer in combination with docetaxel and prednisone (Phase III). An interim analysis is expected to be conducted by an Independent Data Monitoring Committee in mid 2011; final results are anticipated in 2012. – AFFIRM: First-line treatment in metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX) (Phase II). Final results are expected during the second half of 2011.
About Colorectal Cancer2
Colorectal cancer is the third most common cancer after breast and lung – with 110 new cases diganosed in the UK each day. In 2008 there were 39,991 new cases of large bowel cancer registered in the UK ; around two-thirds (25,551) in the colon and one-third (14,440) in the rectum.
References
1. Van Cutsem E, Tabanero J, Lakomy R et al. Intravenous (IV) aflibercept versus placebo in combination with irinotecan/5-Fu (Folfiri) for second-line treatment of metastatic colorectal cancer (MCRC): Results of a multinational phase III trial (EFC10262-VELOUR). Annals of Oncology 22 (Supplement 5): v10-v18, 2011.
2. Cancer Research UK. Bowel (colorectal) cancer – UK incidence statistics. Accessed June 2011. See here.
Source:
Sanofi-aventis