The green light from the National Medical Products Administration of China (formerly the China Food and Drug Administration) is for use of the oral VEGF inhibitor in patients with metastatic CRC who have failed at least two prior systemic rounds of therapy.
Elunate (fruquintinib) will be sold in China by Chi-Med’s commercial partner Eli Lilly, although there’s no word yet on whether the two companies are inclined to develop the drug for use in the US or Europe, particularly as the third-line CRC category is more competitive in those markets. China looks set to be a big market for the drug in its own right, however, as CRC is the second-most common form of cancer with an estimated 380,000 new cases every year.
Elunate will have to go up against well-established oral drugs like Bayer’s multikinase inhibitor Stivarga (regorafenib) and Taiho Oncology’s Lonsurf (trifluridine/tipiracil) in the third-line setting.
The approval has sparked a $13.6m milestone payment from Lilly to Chi-Med, and is a major achievement for the Chinese biopharma company, particularly as other companies have struggled to bring oral VEGF inhibitors to market for CRC.
Chi-Med’s chairman Simon To
“Today’s approval is a major achievement for Chi-Med,” said Simon To, Chairman of Chi-Med. “Elunate is the first home-grown, China-discovered and developed drug we are aware of in an oncology indication to be unconditionally approved through a randomised clinical trial in China,” he added, “This is the result of over a dozen years of steadfast commitment by Chi-Med in research and development in China’s emerging biotech ecosystem.”
Pfizer abandoned a trial of its lung cancer drug Sutent (sunitinib) in first-line CRC a few years ago, while AstraZeneca’s cedirinib failed in this form of cancer as well as other solid tumours. Meanwhile, other orally-active drugs that target VEGF – including Bayer’s Nexavar (sorafenib), Novartis’ Votrient (pazopanib), and Sanofi’s Caprelsa (vandetanib) – have been developed for a range of other solid tumours but not CRC.
Chi-Med says Elunate is a ‘best-in-class’ VEGF inhibitor, which in the phase III FRESCO trial improved overall survival to a median of 9.3 months from 6.6 months with placebo as a third-line therapy for Chinese CRC patients.
One explanation for the good performance of the drug in this trial versus other VEGF drugs tested in Western countries is that Chinese patients are much less likely to have been treated previously with intravenous VEGF drugs, such as Roche’s Avastin (bevacizumab) and Lilly’s Cyramza (ramucirumab).
The Chinese company is now planning to extend fruquintinib’s use into non-small cell lung cancer (NSCLC), as a third-line monotherapy and as part of a first-line regimen alongside AZ’s EGFR inhibitor Iressa (gefitinib), as well as gastric cancer.