b'LONSURF + bevacizumabIMPROVED PROGRESSION-FREE SURVIVAL 1,21009080 5.6months EFFICACY: SECONDARY ENDPOINTPercentage of patients70 (4.5-5.9)60 Median PFS increased50 LONSURF + bevacizumab (n=246) by 3.2 months 40 LONSURF (n=246)30 2.4 HR=0.44 ([95% CI: 0.36-0.54]; P0.001)20 months10 (2.1-3.2)00 1 23 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18MonthNo. at riskLONSURF + bevacizumab 246 242 198 179 153 128 99 89 70 61 52 43 25 18 13 7 4 2 0LONSURF 246 236 147 109 74 56 36 29 19 12 8 6 2 2 1 1 0 0 0SELECTED IMPORTANT SAFETY INFORMATION (contd) ADVERSE REACTIONS (contd)The most common adverse reactions or laboratory abnormalities (20% in incidence) in patients treated with LONSURF in combination with bevacizumab vs LONSURF alone were neutropenia (80% vs 68%), anemia (68%vs 73%), thrombocytopenia (54% vs 29%), fatigue (45% vs 37%), nausea (37% vs 27%), increased aspartate aminotransferase (34% vs 28%), increased alanine aminotransferase (33% vs 23%), increased alkaline phosphate (31% vs 36%), decreased sodium (25% vs 20%), diarrhea (21% vs 19%), abdominal pain (20% vs 18%), and decreased appetite (20% vs 15%).Please see brief summary of Prescribing Information below and on adjacent pages. References: 1. LONSURF. Prescribing Information. Taiho Oncology, Inc; 2023. 2. Prager GW, Taieb J, Fakih M, et al. Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer. N Engl J Med. 2023;388:1657-1667. doi:10.1056/NEJMoa2214963 TAIHO ONCOLOGY, INC. 2023. All rights reserved. LONSURF is a registered trademark of Taiho Pharmaceutical Co., Ltd used under license by Taiho Oncology, Inc. 11/2023 LON-PM-US-1728 v2lower than those achieved at the recommended dosage of 35 mg/m2 twice Initial U.S. Approval: 2015 daily. Advise pregnant women of the potential risk to the fetus. Advise Brief Summary of Prescribing Informationfemales of reproductive potential to use an effective method of contraception nsert. during treatment with LONSURF and for at least 6 months after t1INDICATIONS AND USAGE 6ADVERSE REACTIONS1.1Metastatic Colorectal Cancer ibed elsewhere LONSURF, as a single agent or in combination with bevacizumab, is indicated in the labeling:for the treatment of adult patients with metastatic colorectal cancer Severe Myelosuppression [see Warnings and Precautions (5.1)]chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an6.1Clinical Trials Experienceanti-EGFR therapy. Because clinical trials are conducted under widely varying conditions, adverse 4CONTRAINDICATIONS reaction rates observed in the clinical trials of a drug cannot be directly None. compared to rates in the clinical trials of another drug and ma5WARNINGS AND PRECAUTIONS rates observed in practice.5.1Severe Myelosuppression The data described in the WARNINGS AND PRECAUTIONS section and below In the 1114 patients who received LONSURF as a single agent, LONSURFnts with caused severe or life-threatening myelosuppression (Grade 3-4) consistingmetastatic colorectal cancer in RECOURSE, 246 patients with metastatic of neutropenia (38%), anemia (17%), thrombocytopenia (4%) and febrilecolorectal cancer treated with LONSURF as monotherapy in SUNLIGHT andneutropenia (3%). Three patients (0.3%) died due to neutropenic infection/ 335 patients with metastatic gastric cancer in TAGS. Among the 1114 patients sepsis; four other patients (0.5%) died due to septic shock. A total of 14% ofwho received LONSURF as a single agent, 12% were exposed for 6 months patients received granulocyte-colony stimulating factors. or longer and 1% were exposed for 12 months or longer. The most common In the 246 patients who received LONSURF in combination with bevacizumab,adverse reactions or laboratory abnormalities (10%) were neutropenia, LONSURF caused severe or life-threatening myelosuppression (Grade 3-4)anemia, thrombocytopenia, fatigue, nausea, decreased appetite, diarrhea, consisting of neutropenia (52%), anemia (5%), thrombocytopenia (4%)vomiting, abdominal pain, and pyrexia.and febrile neutropenia (0.4%). One patient (0.4%) died due to abdominalAmong the 246 patients with metastatic colorectal cancer treated with sepsis and two other patients (0.8%) died due to septic shock. A total ofLONSURF in combination with bevacizumab in SUNLIGHT, 39% were 29% of patients received granulocyte-colony stimulating factors. Obtainexposed for 6 months or longer, and 14% were exposed for 12 months or complete blood counts prior to and on Day 15 of each cycle of LONSURFlonger. The most common adverse reactions or laboratory abnormalities and more frequently as clinically indicated. Withhold LONSURF for severe(20%) were neutropenia, anemia, thrombocytopenia, fatigue, nausea, myelosuppression and resume at the next lower dosage [see Dosage andincreased AST, increased ALT, increased alkaline phosphatase, decreased Administration (2.2) in the full Prescribing Information]. sodium, diarrhea, abdominal pain, and decreased appetite.5.2Embryo-Fetal Toxicity Metastatic Colorectal CancerBased on animal studies and its mechanism of action, LONSURF can causeLONSURF as a single agentipiracilThe safety of LONSURF was evaluated in RECOURSE, a randomized (2:1),caused embryo-fetal lethality and embryo-fetal toxicity in pregnant rats whendouble-blind, placebo-controlled trial in patients with previously treated orally administered during gestation at dosage levels resulting in exposuresmetastatic colorectal cancer [see Clinical Studies (14.1) in the full Taiho_Directory_USMed_Dec2023_FullAd_NAout_7.875x10.75_L09.indd 3 11/27/23 6:17 PM'