Lonsurf (Trifluridine/Tipiracil) Receives EU Approval for Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
Sep 07, 2019 10:59
CST Updated
10:59
Taiho Pharmaceutical
Pharmaceutical Product Researcher
Servier
International Pharmaceutical Manufacturers
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
September 07, 2019 News /BioValleyBIOON/ -- French pharmaceutical company Servier and its partner Taiho Pharmaceutical recently announced that the European Commission (EC) has approved Lonsurf (trifluridine/tipiracil) for the treatment of adult patients with metastatic gastric cancer (mGC, including metastatic gastroesophageal junction adenocarcinoma [mGEJC]) who have previously received at least two systemic therapy regimens to control advanced disease. In Europe, approximately 130,000 people are diagnosed with gastric cancer each year, resulting in more than 100,000 deaths annually. The symptoms of gastric cancer are nonspecific, and it is estimated that over 40% of patients have metastatic disease at the time of diagnosis.
In the European Union, the previously approved indication for Lonsurf is: as a monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously been treated with, or are not candidates for, currently available therapies, including chemotherapy regimens containing fluoropyrimidines, oxaliplatin, and irinotecan, as well as anti-VEGF and anti-EGFR agents.
In the United States, Lonsurf was approved in late February this yearFDAApproved for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma who have previously received at least two prior chemotherapy regimens (including a fluoropyrimidine, platinum, and either a taxane or irinotecan; and HER2/neu-targeted therapy, if applicable). This approval expands the U.S. indications for Lonsurf, which was previously approved for patients with metastatic colorectal cancer (mCRC) who have been treated with standard chemotherapy.
This EU approval is based on data from the global Phase III clinical study TAGS (TAS-102 Gastric Study). This randomized, double-blind study evaluated the efficacy and safety of Lonsurf in combination with best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard therapies.
The results demonstrated that the study met both its primary and secondary endpoints: in the overall study population, compared with placebo plus best supportive care (BSC), Lonsurf plus BSC achieved a clinically and statistically significant improvement in overall survival (OS), with a 31% reduction in the risk of death (HR=0.69 [95% CI: 0.56–0.85], p=0.00029) and a 2.1-month extension in median OS (5.7 months vs. 3.6 months). The overall safety profile was consistent with that of Lonsurf in the treatment of metastatic colorectal cancer (mCRC), with hematologic adverse events being the most commonly reported.
In mid-January this year, Dapeng Pharmaceutical at the 2019 American ClinicalTumorEfficacy and safety data for the gastrectomy subgroup from the TAGS study were presented at the ASCO Gastrointestinal Cancers Symposium (ASCO-GI). These results were consistent with those observed in the overall study population. In the TAGS study, 221 (44%) of the 507 randomized patients with metastatic gastric cancer (mGC) had undergone prior gastrectomy (147 received Lonsurf and 74 received placebo), reflectingDiagnosisin the real-world patient population with mGC. The results showed that in this patient subgroup, Lonsurf prolonged overall survival compared with placebo, regardless of prior gastrectomy.
European Lead of the TAGS Study, Director of the Vall d’Hebron Institute of Oncology (VHIO), and Vall d’Hebron University HospitalTumorProfessor Josep Tabernero, Head of Department, stated: “The approval of Lonsurf represents a milestone decision for patients across the entire European Union. Treatment options for patients with metastatic gastric cancer remain limited, making it crucial to provide new therapeutic approaches. Data from the phase III TAGS study support Lonsurf as an effective and tolerable treatment for patients with refractory metastatic gastric cancer. Prior to today’s approval, there was no approved standard of care for patients with very poor prognosis whose disease had progressed after previous treatments. This means that the approval marks an important step forward for patients with limited prior treatment options.”
ServierTumorPatrick Therase, Head of R&D, stated: “Gastric cancer is difficult to treat, and every step forward represents a significant advance. Lonsurf offers a treatment option for metastatic gastric cancer with higher survival rates than standard therapy. We are very pleased that Lonsurf has been approved today. Given the challenges in treating metastatic gastric cancer, it is important that clinicians have access to a range of treatment options. We will now work with health technology assessment agencies across Europe to ensure that eligible patients can access Lonsurf treatment as soon as possible.”
Lonsurf is a novel oral antimetabolite combination drug, composed of anti-TumorIt consists of the nucleoside analog FTD (trifluridine) and the thymidine phosphorylase inhibitor TPI (tipiracil). FTD can directly incorporate into the DNA double helix by substituting for thymine during DNA replication, leading to DNA dysfunction and interfering with cancer cell DNA synthesis; TPI inhibits thymidine phosphorylase, which is involved in FTD degradation, thereby reducing FTD breakdown and maintaining its plasma concentration.
As of August 2019, Lonsurf had been approved in 72 countries worldwide for the treatment of patients with metastatic colorectal cancer (mCRC), specifically adult patients with mCRC who had previously been treated with, or were not candidates for, existing therapies (including fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy, anti-VEGF agents, and anti-EGFR agents). In February 2019, Lonsurf received approval in the United States for a new indication: the treatment of adult patients with metastatic gastric cancer (mGC) or 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 jointly develop and commercialize Lonsurf in Europe, the United States, Canada, Mexico, and other countries outside Asia. (Bioon.com)