Trifluridine/Tipiracil Plus Bevacizumab Reaches Survival Endpoint in mCRC

Trifluridine/tipiracil (Lonsurf) and bevacizumab (Avastin) yielded a statistically significant improvement in the primary endpoint of overall survival (OS) compared with trifluridine/tipiracil alone in patients with refractory, metastatic colorectal cancer (mCRC), according to a press release on initial findings from the open-label, randomized phase 3 SUNLIGHT study (NCT04737187).

The SUNLIGHT trial met its primary endpoint of OS, measured through a time frame of approximately 12 months. The study’s OS data and other findings will be presented at an upcoming international conference.

“Findings from the SUNLIGHT trial could potentially represent a significant advancement in the treatment of patients with metastatic colorectal cancer who have progressed after two lines of standard chemotherapy. Combining trifluridine/tipiracil with bevacizumab demonstrated the potential to extend survival in these patients who have limited therapeutic options,” Nadia Caussé-Amellal, MD, head of global development, gastrointestinal indications, and oncology and immuno-oncology therapeutic area at Servier, said in the press release.

In the SUNLIGHT trial, 492 patients were randomly assigned 1:1 to receive either trifluridine/tipiracil in combination with bevacizumab or trifluridine/tipriracil monotherapy. Patients in the combination arm received oral triflurdine/tipiracil 2 times a day in a 5 days on/2 days off schedule for 2 weeks followed by a 14-day rest, and bevacizumab once every 2 weeks on days 1 and 15. Patients in the monotherapy arm received the same trifluridine/tipiracil backbone.

Secondary study end points included progression-free survival, overall response rate, disease control rate, treatment-emergent adverse effects (AEs) and serious AEs, and quality of life.

Patients 18 years and older were eligible to participate in the study if they had histologically confirmed unresectable adenocarcinoma of the colon or rectum. Additional eligibility criteria included previously defined RAS status, treatment with a maximum of 2 prior chemotherapy regimens for advanced CRC, a measurable or non-measurable disease as defined by RECIST version 1.1 criteria, and the ability to swallow oral tablets. Patients also needed to have an estimated life expectancy of 12 or more weeks and an ECOG performance status of 0 or 1.

Patients were excluded from the study if they had more than 2 previous chemotherapy regimens for advanced CRC, were pregnant, received anticancer therapies 4 weeks prior to randomization, or had symptomatic central nervous system metastases. Other exclusion criteria included severe or uncontrolled active acute or chronic infections and known Hepatitis B or Hepatitis C virus infections.

“[Trifluridine/tipiracil] has had a significant impact on the management of colorectal cancer for thousands of patients,” Fabio Benedetti, MD, global chief medical officer of Oncology at Taiho Pharmaceutical, concluded. “The results of [the phase 3 SUNLIGHT] study may represent another advancement in the management of this disease, and we now look forward to the further analysis of secondary endpoints.”

Reference

Drug combination meets survival endpoint in phase III pivotal trial involving participants with refractory Metastatic Colorectal Cancer. News release. Servier and Taiho Oncology. September 12, 2022. Accessed September 23, 2022. https://bit.ly/3SosAd2