New cancer drugs! The new anti-metabolic compound Lonsurf of Schweija/Dapeng Pharmaceuticals significantly improved survival in the gastric excision subgroup

Servier and Taiho Pharmaceutical recently jointly announced that they are evaluating the safety and efficacy of gastric excision groups in TAGS, a global Phase III clinical study of patients treated with metastatic gastric cancer (mGC) by Lonsurdine/tipiracil, in line with the overall findings published in The Lancet Oncology. The data were released at the 2019 American Society of Clinical Oncology Gastrointestinal Cancer Symposium (ASCO-GI) held on the 17th of this month.
In the TAGS study, 221 (44%) of the 507 randomized mGC patients had undergone a gastrectomy (147 were treated with Lonsurf and 74 were treated with a placebo), reflecting the real-world patient population diagnosed with mGC. The results showed that in this patient subgroup, Lonsurf extended total survival compared to placebo, independent of previous gastric excisions.
results from the TAGS study of the entire patient population showed that Lonsurf improved the overall survival of clinical and statistical significance, reduced the risk of death by 31% (HR-0.69, single-arm p-0.00029), and extended the total survival of the middle by 2.1 months (5.7 months vs 3.6 months).
Lonsurf is a new oral anti-metabolic compound drug consisting of the anti-tumor nucleoside analoga FTD (trifluorotide, trifluridine) and the thoracic glycoside phosphorylase inhibitor TPI (tipiracil). Among them, FTD can replace thymus directly into the DNA double strand in the DNA replication process, resulting in DNA dysfunction, interfere with the synthesis of cancer cell DNA, TPI can inhibit thymus phosphorylase associated with FTD decomposition, reduce FTD degradation, maintain FTD blood drug concentration.
As of December 2018, Lonsurf has been approved by 62 countries worldwide for the treatment of patients with advanced metastatic colorectal cancer (mCRC) in adult CRC patients who have previously received or are not suitable for existing therapies (including fluorouracil, oxali or pritorycon-based chemotherapy, anti-VEGF preparations, anti-EGFR preparations).
In October 2018, the FDA accepted a new drug supplement application (sNDA) from Lonsurf and granted priority review eligibility, which approved Lonsurf for use in patients with past treated, advanced or metastatic gastric adenocarcinoma, including gastroesophageal junction cancer. The FDA has designated the SNDA's Prescription Drug User Charge Act (PDUFA) target date of February 24, 2019. (Bio Valley)