Servier, Taiho score in phase 3 colorectal cancer trial to support Lonsurf combo nod

After gaining FDA approvals in 2015 and 2019 for Lonsurf, Servier and Taiho Oncology are due for a third nod this year for the cancer treatment.

Based on data from a phase 3 trial of Lonsurf in combination with Avastin, the companies could be on track to meet their every-four-years routine.

In the SUNLIGHT trial, which included 492 patients with refractory metastatic colorectal cancer who had shown intolerance to two prior chemo treatments, Lonsurf produced a statistically significant improvement in overall survival.

Patients who received Lonsurf plus Roche's Avastin lived a median of 10.8 months compared to 7.5 months for those on Lonsurf alone. This equates to a 39% reduction of in the risk of death. As for a secondary endpoint, patients on the combo stayed alive without disease progression for an average of 5.6 months versus 2.4 months.  

“Coupled with the fact that cases of colorectal cancer are increasing, there is an urgent need for new treatment options that can extend survival in patients with metastatic colorectal cancer in the later stages of disease,” Professor Josep Tabernero, M.D., Ph.D., the head of medical oncology at Vall d’Hebron University Hospital in Barcelona, Spain, and principal investigator for the trial, noted in the companies' press release.

Servier and Taiho will submit the results to regulatory authorities in the coming months, the companies said. They will present the results Saturday at the ASCO Gastrointestinal Cancers Symposium in San Francisco.

The primary competition in third-line colorectal cancer is another aging treatment, Bayer’s Stivarga, which has been on the market for 10 years. Hutchmed’s fruquintinib showed promise in the same indication and could eventually join the competition.

Lonsurf was approved in 2015 as a solo agent for third-line colorectal cancer following two chemotherapy treatments. In 2019, an approval in third-line gastric cancer followed, again for those who resisted two chemotherapy treatments.