- An investigational oncology drug is well on its way to offering patients in China whose colorectal cancers have worsened or spread a third-line treatment option for their disease.
- Hutchinson China MediTech, often called Chi-Med, and Eli Lilly revealed more detailed results from the Phase 3 FRESCO study of their candidate, fruquintinib, at the American Society of Clinical Oncology's annual conference on Monday.
- Data showed patients taking drug along with best supportive care (BSC) had median overall survival (OS) of 9.3 months versus 6.57 months for participants receiving BSC and placebo. What's more, median progression-free survival (PFS) was 3.71 months in the treatment arm and 1.84 months in the control group.
Chi-Med plans to file its drug with the Chinese Food and Drug Administration "immediately," according to the statement. As for other markets, the company anticipates kicking off clinical investigations in the U.S. later this year.
While serious side effects did arise in the experimental arm, such as more than 20% of patients reporting grade 3 or higher hypertension, the companies noted in a June 5 statement that fruquintinib "had a manageable safety profile with lower off-target toxicities compared to other targeted therapies, and did not demonstrate the sometimes severe and fatal hepatotoxicity (liver toxicity) observed with other therapies in this disease setting."
Helping the drug's cause is the fact that it also hit several secondary endpoints in the Phase 3 study. Patients in the treatment arm had a disease control rate of 62.2% compared to 12.3% for those one placebo. The overall response rate between the two groups was 4.7% and 0%, respectively.
If fruquintinib ever does make it to market in the U.S., it will have some stiff competition. FRESCO, for instance, evaluated the drug in patients with locally advanced or metastatic forms of colorectal cancer who had not previously responded to at least two anti-tumor agents, such as fluoropyrimidine, oxaliplatin (the active ingredient in Sanofi's Eloxatin) and irinotecan (the active ingredient in Pfizer's Camptosar.)
There are already multiple drugs, however, that the Food and Drug Administration has green lit as third-line treatments for colorectal cancer. They include Taiho Oncology's Lonsurf (trifluridine and tipiracil) and Bayer's Stivarga (regorafenib). A combo of Lilly's Cyramza (ramucirumab) and FOLFIRI — itself a mixture of folinic acid, fluorouracil and Camptosar — has also been approved in the second-line setting for patients whose diseases advanced following treatment from Roche's Avastin (bevacizumab), oxaliplatin, and a fluoropyrimidine.
Fruquintinib works by inhibiting vascular endothelial growth factor receptor (VEGFR), proteins that promote the development of blood vessels and therefore can spur tumor growth. Where Chi-Med and Lilly can differentiate their drug is through a stronger safety profile than other VEGFR blockers, yet that still presents challenges. Whereas nearly one-fifth of those treated with fruquintinib experienced grade 3 or higher hypertension, 8% of patients receiving Stivarga in another clinical study reported serious hypertension, according to the FDA.
Chi-Med and Lilly aren't limiting the drug to just the colorectal cancer space, though. Mid- and late-stage studies of fruquintinib monotherapy and combination therapy for non-small cell lung cancer patients are already underway in China. The companies also have another Phase 3 study testing the drug as a gastric cancer therapy in the works.