Meaningful new treatment option for metastatic colorectal cancer from Taiho Oncology and Servier
Results from a multinational trial of trifluridine/tipracil, known as Lonsurf, with or without bevacizumab in refractory metastatic colorectal cancer (mCRC) have resulted in statistically significantly and clinically meaningful improvements.
These occurred in overall survival and progression free survival for patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens compared to trifluridine/tipiracil alone.
Results of this multinational trial, led by Josep Tabernero, head of medical oncology, Vall d’Hebron University Hospital, Spain, also showed the median time to worsening of Eastern Cooperative Oncology Group (ECOG) performance-status score was significantly delayed in patients receiving the investigational combination of trifluridine/tipiracil and bevacizumab.
The safety profile of the investigational combination was consistent with that of each agent.
Marwan Fakih, lead investigator in the US for the Sunlight trial, said: “Individuals living with metastatic colorectal cancer and who have progressed following fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-Epidermal Growth Factor Receptor (EGFR) antibodies – if RAS wild-type – have limited treatment options. There is a growing need for new approaches that improve survival in this population.
“The publication of the SUNLIGHT results in this month's New England Journal of Medicine speaks to the quality of the science and potential impact of this investigational combination on the treatment of metastatic colorectal cancer.”
Tabernero added: “Trifluridine/tipiracil plus bevacizumab may represent a meaningful new treatment option in patients with mCRC who have progressed after two lines of therapy.”
Based on results of the Sunlight trial, Servier and Taiho Oncology submitted respectively a type 2 variation for approval to the European Medicines Agency (EMA) and a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for trifluridine/tipiracil in combination with bevacizumab for the treatment of adult patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and RAS wild-type, an anti-EGFR therapy.
Taiho Oncology announced on April 18, 2023, that the FDA accepted the sNDA for Priority Review and set an anticipated Prescription Drug User Fee Act (PDUFA) action date of August 13, 2023.
Researchers say that colorectal cancer is the third most common cancer worldwide with nearly 1.4 million people diagnosed with colorectal cancer (CRC) each year equating to 10% of the global cancer cases.
SUNLIGHT is a multinational, randomized, active-controlled, open-label, two-arm phase 3 clinical trial to investigate the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone, in patients with refractory mCRC following two chemotherapy regimens.
A total of 492 patients were randomly allocated in a 1:1 ratio to receive trifluridine/tipiracil in combination with bevacizumab or trifluridine/tipiracil monotherapy.