Taiho Oncology and Servier To Present Data on LONSURF® (trifluridine and tipiracil) at 2021 ASCO Gastrointestinal Cancers Symposium (ASCO GI)
PRINCETON, N.J., Jan. 12, 2021 /PRNewswire/ -- Taiho Oncology, Inc. and Serviertoday announced that data for LONSURF® (trifluridine and tipiracil) in previously treated patients with metastatic gastric cancer (mGC) and metastatic gastroesophageal junction adenocarcinoma (mGEJC) will be presented during the 2021 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI), taking place virtually from January 15-17, 2021. Key presentations include:
Additional information can be found at Taiho Oncology's virtual Medical Booth when the exhibit opens on January 15, 2021.
"We are pleased to facilitate the global collaboration of the TAGS investigators, which is reflected in these abstracts," said Karin Blakolmer, MD, MBA, Senior Vice President and Head of Medical Affairs, Taiho Oncology, Inc. "This partnership is critical as we continue to seek opportunities to optimize the use of LONSURF for patients suffering from advanced gastric cancer."
"These data will continue to broaden our knowledge of how LONSURF performs in patients living with metastatic gastric cancer and gastroesophageal junction adenocarcinoma following previous rounds of treatment," said François Druguet, Head of Global Medical Affairs Oncology, Servier.
The U.S. Food and Drug Administration (FDA) approved LONSURF in previously treated mGC and mGEJC in February 2019.1 The approval builds on the initial U.S. approval of LONSURF in 2015 for the treatment of adult 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.1
The TAGS trial enrolled 507 adult patients with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. The study was conducted in 17 countries and 110 sites around the world.
About Metastatic Gastric Cancer
In the U.S., standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. After failure of first- and second-line therapies, subsequent treatment options are limited.
About Gastroesophageal Junction Cancer
Since 2015, Taiho Pharmaceutical and Servier have been in an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.
Indications and Use
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
LONSURF caused severe and life–threatening myelosuppression (Grade 3–4) consisting of neutropenia (38%), anemia (18%), thrombocytopenia (5%), and febrile neutropenia (3%). Two patients (0.2%) died due to neutropenic infection. A total of 12% of LONSURF–treated patients received granulocyte–colony stimulating factors. Obtain complete blood counts prior to and on day 15 of each cycle of LONSURF and more frequently as clinically indicated. Withhold LONSURF for febrile neutropenia, absolute neutrophil count less than 500/mm3, or platelets less than 50,000/mm3. Upon recovery, resume LONSURF at a reduced dose as clinically indicated.
LONSURF can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 6 months after the final dose.
USE IN SPECIFIC POPULATIONS
Lactation: It is not known whether LONSURF or its metabolites are present in human milk. There are no data to assess the effects of LONSURF or its metabolites on the breast–fed infant or the effects on milk production. Because of the potential for serious adverse reactions in breast–fed infants, advise women not to breastfeed during treatment with LONSURF and for 1 day following the final dose.
Male Contraception: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for at least 3 months after the final dose.
Geriatric Use: Patients 65 years of age or over who received LONSURF had a higher incidence of the following compared to patients younger than 65 years: Grade 3 or 4 neutropenia (46% vs 32%), Grade 3 anemia (22% vs 16%), and Grade 3 or 4 thrombocytopenia (7% vs 4%).
Hepatic Impairment: Do not initiate LONSURF in patients with baseline moderate or severe (total bilirubin greater than 1.5 times ULN and any AST) hepatic impairment. Patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) were not studied. No adjustment to the starting dose of LONSURF is recommended for patients with mild hepatic impairment.
Renal Impairment: No adjustment to the starting dosage of LONSURF is recommended in patients with mild or moderate renal impairment (CLcr of 30 to 89 mL/min). Reduce the starting dose of LONSURF for patients with severe renal impairment (CLcr of 15 to 29 mL/min) to a recommended dosage of 20 mg/m2.
Most Common Adverse Drug Reactions in Patients Treated With LONSURF (≥5%): The most common adverse drug reactions in LONSURF–treated patients vs placebo–treated patients with mCRC, respectively, were asthenia/fatigue (52% vs 35%), nausea (48% vs 24%), decreased appetite (39% vs 29%), diarrhea (32% vs 12%), vomiting (28% vs 14%), infections (27% vs 16%), abdominal pain (21% vs 18%), pyrexia (19% vs 14%), stomatitis (8% vs 6%), dysgeusia (7% vs 2%), and alopecia (7% vs 1%). In metastatic gastric cancer or gastroesophageal junction (GEJ), the most common adverse drug reactions, respectively were, nausea (37% vs 32%), decreased appetite (34% vs 31%), vomiting (25% vs 20%), infections (23% vs 16%) and diarrhea (23% vs 14%).
Pulmonary emboli occurred more frequently in LONSURF–treated patients compared to placebo: in mCRC (2% vs 0%) and in metastatic gastric cancer and GEJ (3% vs 2%).
Interstitial lung disease (0.2%), including fatalities, has been reported in clinical studies and clinical practice settings in Asia.
Laboratory Test Abnormalities in Patients Treated With LONSURF: The most common laboratory test abnormalities in LONSURF–treated patients vs placebo-treated patients with mCRC, respectively, were anemia (77% vs 33%), neutropenia (67% vs 1%), and thrombocytopenia (42% vs 8%). In metastatic gastric cancer or GEJ, the test abnormalities, respectively, were neutropenia (66% vs 4%), anemia (63% vs 38%), and thrombocytopenia (34% vs 9%).
Please see full Prescribing Information.
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LONSURF® is a registered trademark of Taiho Pharmaceutical Co., Ltd. used under license by Taiho Oncology, Inc.
Copyright © TAIHO ONCOLOGY, INC. 2020
1 LONSURF [US prescribing information]; Princeton, NJ: Taiho Oncology, Inc.; 2020. 2020.
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SOURCE Taiho Oncology, Inc.