Taiho scores expanded US label for Lonsurf in colorectal cancer
02 Aug 2023
Phase 3Clinical ResultDrug Approval
The FDA said Wednesday that it approved Taiho Oncology's Lonsurf (trifluridine/tipiracil) in combination with bevacizumab for previously treated adults with metastatic colorectal cancer (mCRC). Lonsurf has been cleared in the US for use as a single agent since 2015.
Specifically, the drug is now indicated either alone or with bevacizumab for mCRC patients previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. The decision comes on the heels of Taiho's partner Servier obtaining a similar EU nod for Lonsurf plus bevacizumab for third-line refractory mCRC earlier this week.
The latest FDA approval was backed by data from the Phase III SUNLIGHT trial evaluating Lonsurf either as a single-agent or in combination with bevacizumab in 492 patients with mCRC who received a maximum of two prior chemotherapy regimens and demonstrated progressive disease or intolerance to the last one.
Combo showed 39% OS benefit
Results demonstrated a statistically significant 39% improvement on the primary endpoint of overall survival (OS) in patients randomised to Lonsurf plus bevacizumab, versus Lonsurf alone. Median OS was 10.8 months for those given Lonsurf plus bevacizumab, versus 7.5 months for the single-agent arm. In addition, median progression-free survival (PFS) was 5.6 months for those who received the combination, compared to 2.4 months for Lonsurf alone, indicating a 56% relative risk reduction of disease progression.
Taiho said the combination of Lonsurf plus bevacizumab had a manageable safety profile, with the most frequent severe treatment emergent adverse events being neutropenia, which occurred at rates of 43.1% and 32.1% for the combination and single-agent arms, respectively, and anaemia, where the rates were 6.1% and 11%, respectively.
Lonsurf was also approved by the FDA in 2019 as a treatment for adult patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma.
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