Generics
Clinical Data from Taiho Oncology and Servier Study of Lonsurf (trifluridine and tipiracil) in Metastatic Colorectal Cancer Presented at ASCO 2018 Gastrointestinal Cancers Symposium
24 January 2018 - - Princeton, New Jersey-based cancer therapeutics developer Taiho Oncology, Inc. and Suresnes, France-based international pharmaceutical company Servier have released clinical data for Lonsurf (trifluridine and tipiracil) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild type, an anti-EGFR therapy, the companies said.
A phase I multicenter, open-label study examined the maximum tolerated dose of a Lonsurf and oxaliplatin combination in patients with mCRC.
A safety and tolerability assessment was conducted among elderly patients (age ≥65 years) with mCRC that participated in a Lonsurf expanded access program in the US. The results of the analysis showed that the safety profile and treatment duration of Lonsurf in patients aged 65 and older with mCRC were similar to those in patients aged under 65.
A post-hoc analysis of the pivotal phase 3 RECOURSE study was conducted to assess the correlation between baseline neutrophil-to-lymphocyte ratios in the blood of patients with refractory mCRC treated with Lonsurf and clinical outcomes. Further research is warranted to assess if NLR can be a stratification factor in mCRC clinical trials.
Lonsurf is a combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor, indicated in US for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
Taiho Oncology, Inc., a subsidiary of Taiho Pharmaceutical Co., Ltd. and Otsuka Holdings Co., Ltd., has established a clinical development organization that works urgently to develop innovative cancer treatments and has built a commercial business in the US. The company has an oral oncology pipeline consisting of both novel antimetabolic agents and selectively targeted agents.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R and D-driven specialty pharma focusing on the fields of oncology, allergy and immunology, and urology. The company is expanding its global R and D efforts and recently established commercial operations in the US.
Servier, governed by a non-profit foundation, has an international presence in 148 countries and employs 21,000 people worldwide. Entirely independent, the group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development in five areas: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancers and diabetes.
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