The approval is based on the results of the Phase 3 SUNLIGHT trial in which the combination of Lonsurf and bevacizumab significantly and clinically meaningfully improved OS and PFS in mCRC patients
A micrograph of a moderately differentiated colorectal cancer. (Credit: Mikael Häggström, M.D. from Wikimedia Commons)
Taiho Oncology and Taiho Pharmaceutical have received the US Food and Drug Administration (FDA) approval for Lonsurf (trifluridine/tipiracil) as a single agent or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC).
The approval is indicated for patients who were previously treated with irinotecan-based chemotherapy and fluoropyrimidine-, oxaliplatin-, and if RAS wild-type, an anti-EGFR therapy.
Lonsurf is an oral nucleoside antitumor agent that has the thymidine phosphorylase (TP) inhibitor, tipiracil and thymidine-based nucleoside analogue, trifluridine.
The approval is based on the results of the Phase 3 SUNLIGHT trial.
According to the findings, the combination of Lonsurf and bevacizumab significantly and clinically meaningfully improved overall survival (OS) and progression-free survival (PFS) for patients with mCRC who had progressed or become intolerant to two prior chemotherapy regimens against Lonsurf alone.
Japan-based Taiho Oncology said that the improvement in OS characterised a reduction of 39% in the risk of death in patients with mCRC. The median PFS represented a 56% reduction in the relative risk of disease progression.
From baseline to cycle 6, the OS and PFS advantages of the nucleoside antitumor agent with bevacizumab were related to the maintenance of quality of life.
Additionally, no clinically significant changes in mean scores for any subdomains of the EORTC QLQ-C30 and EuroQol EQ-5D-5L health-related quality-of-life questionnaires were observed.
Taiho Oncology president and CEO Timothy Whitten said: “The treatment of advanced colorectal cancer has been a core focus of our work at Taiho Oncology since our inception and with good reason: approximately 22% of patients with colorectal cancer in the US are diagnosed after the cancer has metastasised.
“The FDA approval of LONSURF in combination with bevacizumab is another example of how we are continuing to advance care in this disease and provide new hope to patients and their families.”
SUNLIGHT is a randomised, active-controlled, open-label, two-arm Phase 3 clinical trial with a goal to assess the safety and efficacy of Lonsurf plus bevacizumab against the nucleoside antitumor agent alone.
It randomised 492 patients in a 1:1 ratio to receive Lonsurf / bevacizumab or Lonsurf monotherapy.
The primary endpoint was defined as the improvement in OS. Key secondary endpoints included PFS, overall response rate (ORR), disease control rate (DCR) and quality of life (QoL), along with safety and tolerability of both arms.