Servier Advances Phase III SOLSTICE Trial of Lonsurf (Trifluridine/Tipiracil) Plus Bevacizumab as First-Line Therapy for Unresectable Metastatic Colorectal Cancer
Oct 24, 2021 03:10
CST Updated
03:10
Servier
International Pharmaceutical Manufacturers
Colorectal cancer (Image source: medicalnewstoday.com)
October 22, 2021 /BioonBIOON/ -- French pharmaceutical company Servier recently announced,The Phase 3 SOLSTICE trial (NCT03869892) did not meet the primary endpoint (progression-free survival, PFS) in the initial analysis.. This is an open-label, randomized, multicenter phase 3 trial conducted in 856 patients with unresectable metastatic colorectal cancer (mCRC) who are ineligible for or do not require intensive chemotherapy, evaluatingLonsurf (trifluridine/tipiracil) plus bevacizumab regimen and capecitabine plus bevacizumab regimen for first-line treatmentefficacy and safety. The primary objective is to demonstrate the superiority of the Lonsurf + bevacizumab regimen over the capecitabine + bevacizumab regimen in terms of PFS.
Given that no adverse effects or new safety concerns have been observed in either of the two study groups, the trial will proceed as planned. Preliminary analysis data will be presented at the upcoming medical conference.
Worldwide, nearly 1.4 million people areDiagnosisColorectal cancer (CRC) accounts for 10% of global cancer cases. In Europe, CRC is the second most common cause of cancer-related death, with a 5-year survival rate of only 11% for patients with metastatic disease (when cancer spreads from its primary site to other parts of the body). Standard chemotherapy regimens for mCRC include fluoropyrimidines, oxaliplatin, irinotecan, or targeted therapies, such as drugs targeting vascular endothelial growth factor (VEGF) or epidermal growth factor receptor (EGFR).
Prof. Thierry André, MD, Principal Investigator of the SOLSTICE trial at Hôpital Saint-Antoine, Paris, France, stated: “Patients with metastatic colorectal cancer (mCRC) who are unfit for intensive chemotherapy have limited treatment options, and quality of life is a priority. We are continuously exploring new approaches to provide these patients with effective, low-toxicity therapies.”
Servier Oncology and ImmunologyTumorDr. Patrick Therasse, Deputy Director of Therapeutics and Director of Late-Stage and Lifecycle Management, stated: “We remain committed to improving outcomes in mCRC, and we will continue to follow patients as planned to conduct the key secondary endpoint analysis for overall survival (OS) in 2023. The clinical value of Lonsurf in its current indications remains unchanged, and the ongoing Phase 3 SUNLIGHT trial (comparing Lonsurf plus bevacizumab versus Lonsurf in third-line mCRC) is proceeding as planned.”
Lonsurf is a novel oral antimetabolite combination drug, consisting of anti-Tumorcomposed of the nucleoside analogue FTD (trifluridine) and the thymidine phosphorylase inhibitor TPI (tipiracil).Specifically, FTD can directly incorporate into double-stranded DNA by substituting for thymidine during DNA replication, leading to DNA dysfunction and interfering with cancer cell DNA synthesis; meanwhile, TPI inhibits thymidine phosphorylase, which mediates FTD degradation, thereby reducing FTD breakdown and maintaining its plasma concentration.
As of October 2021, Lonsurf has been approved in 96 countries worldwide for the treatment of patients with advanced metastatic colorectal cancer (mCRC), specifically: adult patients with mCRC who have previously received, or are not candidates for, available therapies (including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF agents, and anti-EGFR agents). Additionally, Lonsurf has been approved in 80 countries for the treatment of adult patients with metastatic gastric cancer (mGC) / metastatic gastroesophageal junction adenocarcinoma (mGEJC).
Lonsurf was discovered and developed by Taiho Pharmaceutical. In June 2015, Servier and Taiho Pharmaceutical entered into an exclusive licensing agreement to co-develop and commercialize Lonsurf in Europe and other countries outside the United States, Canada, Mexico, and Asia. (Bioon.com)