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Metastatic Colorectal Cancer

Why Lonsurf?

LONSURF: An antimetabolite combination agent studied in previously treated metastatic colorectal, GEJ, and gastric cancers1‑5

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Patient Considerations

Consider LONSURF in your treatment plan

LONSURF® (FTD/TPI) tablets was studied in the RECOURSE trial1,2

  • Patients, ranging from 27 to 82 years of age, had ≥2 lines of prior treatment and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 98% of patients in the LONSURF arm were refractory to or were failing on a fluoropyrimidine-based therapy in a prior treatment regimen

LONSURF patient considerations1,6

  • Has already received multiple types of treatment, including fluorouracil (5-FU)
  • Wants to maintain their ECOG performance status
  • Is a candidate for oral chemotherapy

RECOURSE was an international, randomized, double-blind, placebo-controlled phase 3 trial.* All patients were >18 years of age, had ECOG performance status of 0 or 1, and had received at least 2 prior regimens of standard chemotherapy and were refractory to or were failing all of the following within 3 months: fluoropyrimidine, irinotecan, and oxaliplatin; an anti-VEGF biological therapy; and, if RAS wild type, an anti-EGFR therapy, which could have included adjuvant chemotherapy if a tumor had recurred within 6 months after the last administration of this therapy. The primary efficacy endpoint was overall survival (OS).1,2,7

Patients were randomized 2:1 to receive either LONSURF 35 mg/m2 (n=534) or placebo (n=266) twice daily after meals for 5 days a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks plus best supportive care.1

All patients were followed for survival at scheduled 8-week intervals with computed tomography (CT) scans until 12 months after the first dose of study medication from the last patient randomized. After the end of treatment, all patients were followed for survival at scheduled 8-week time intervals until death.7

*Treatment arms were LONSURF plus best supportive care vs placebo plus best supportive care.1

Mechanism of Action

LONSURF interferes with the DNA of tumor cells to inhibit proliferation1,2,4

How LONSURF® (FTD/TPI) tablets works1,2

  • Inhibits rapid degradation of trifluridine, which subsequently prevents tumor growth
  • Has been demonstrated to provide anti-tumor activity against KRAS wild-type and mutated human colorectal cancer xenografts in mice

FTD/TPI = trifluridine/tipiracil

References: 1. LONSURF [Prescribing Information]. Princeton, NJ: Taiho Oncology, Inc.; 2019. 2. Mayer RJ, Van Cutsem E, Falcone A, et al; for the RECOURSE Study Group. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015; 372(20):1909-1919. 3. Uboha N, Hochster HS. TAS-102: a novel antimetabolite for the 21st Century. Future Oncol. 2016;12(2):153-163. 4. Matsuoka K, Iimori M, Niimi S, et al. Trifluridine induces p53-dependent sustained G2 phase arrest with its massive misincorporation into DNA and few DNA strand breaks. Mol Cancer Ther. 2015;14(4):1004-1013. 5. Lenz H-J, Stintzing S, Loupakis F. TAS-102, a novel antitumor agent: a review of the mechanism of action. Cancer Treat Rev. 2015;41(9): 777-783. 6. Van Cutsem E, Falcone A, Garcia-Carbonero R, et al. Proxies of quality of life in metastatic colorectal cancer: analyses in the RECOURSE trial. ESMO Open. 2017; 2(5): e000261. 7. Data on file. Taiho Oncology, Inc., Princeton, NJ.

INDICATIONS

INDICATIONS

LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.

LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy.

Indications and Important Safety Information +

INDICATIONS

LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine‑, oxaliplatin‑ and irinotecan‑based chemotherapy, an anti‑VEGF biological therapy, and if RAS wild type, an anti‑EGFR therapy.

LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu‑targeted therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Severe Myelosuppression: 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.

Embryo‑Fetal Toxicity: 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). Patients with severe renal impairment (CLcr < 30 mL/min) were not studied.

ADVERSE REACTIONS

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: (2% vs 0%) in mCRC and (3% vs 2%) in metastatic gastric cancer and GEJ.

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: 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.