With Takeda and Hutchmed hot on the trail, Taiho wins FDA nod for stronger Lonsurf regimen in colorectal cancer

Eight years after an initial FDA approval in heavily pretreated colorectal cancer, Taiho Oncology’s Lonsurf has won another green light in the same indication but as part of a more powerful regimen.

Instead of a single-agent regimen, the FDA on Wednesday cleared Lonsurf to be used alongside bevacizumab for previously treated metastatic colorectal cancer. Patients who have tried an anti-VEGF inhibitor such as bevacizumab—originally developed by Roche as Avastin—may also qualify for this new combo.

The Lonsurf-bevacizumab cocktail proved to be more efficacious than Taiho’s drug alone. Compared with Lonsurf monotherapy, the new combination significantly reduced the risk of death by 39% in a group of patients who had previously received a maximum of two prior chemotherapy regimens and an anti-VEGF agent, plus, in some cases, an anti-EGFR therapy such as Eli Lilly’s Erbitux.

In that phase 3 trial, patients who received the combo lived a median 10.8 months, while those in the Lonsurf arm lived a median 7.5 months.

The FDA doled out this approval under the priority review pathway. It comes as Lonsurf nears a clash with Takeda and Hutchmed’s fruquintinib in colorectal cancer.

In a group of colorectal patients who have exhausted treatments, fruquintinib reduced the risk of death by 34% over placebo. Patients who got the VEGFR inhibitor lived a median 7.4 months. But fruquintinib achieved that overall survival number in the FRESCO-2 trial in a more heavily pretreated population; some patients had also tried Bayer’s Stivarga, Lonsurf or a PD-1 agent.

After Hutchmed released those data last fall, Takeda in January put down $400 million upfront and promised up to $730 million in potential milestones to in-license fruquintinib outside of China. In China, the drug is already approved under the brand name Elunate.

The FDA has also put fruquintinib’s application in colorectal cancer under priority review, having assigned the application a target decision date of Nov. 30.

Besides colorectal cancer, Hutchmed is also gunning for Lonsurf’s stomach cancer indication with a positive China phase 3 readout in the second-line setting. But that study likely won’t be able to support a U.S. approval given the FDA's stance on China-only studies.