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    DRUG:

    Lonsurf (trifluridine/tipiracil)

    i
    Other names: TAS102, TAS-102, S 95005, FTD/TPI, S 95005/TAS-102, T15, T20, TAS 102, trifluridine AND tipiracil, T15/T20, TAS-102/S-95005, S-95005, S95005
    Company:
    Otsuka, Servier, TTY Biopharm
    Drug class:
    Thymidine phosphorylase inhibitor
    1d
    A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov)
    P3, N=700, Recruiting, AbbVie | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • telisotuzumab adizutecan (ABBV-400)
    1d
    Prolonged multimodal disease control with trifluridine/tipiracil plus bevacizumab in KRAS-mutant metastatic rectal cancer: a case report. (PubMed, Anticancer Drugs)
    We present a 57-year-old man with KRAS G13D-mutant, liver-dominant metastatic rectal adenocarcinoma and recurrent fluoropyrimidine-associated coronary vasospasm precluding 5-fluorouracil and capecitabine. After multimodal first-line therapy and regorafenib, trifluridine/tipiracil (TAS-102) plus bevacizumab was initiated and integrated with liver-directed treatments for oligoprogressive disease. This combined strategy achieved approximately 16.6 months of disease control, substantially exceeding the median progression-free survival reported in the SUNLIGHT trial, with manageable hematological toxicity and preserved performance status. This case highlights the value of TAS-102 plus bevacizumab combined with focal liver-directed therapy as a feasible long-term strategy for selected patients with oligoprogressive mCRC when fluoropyrimidines cannot be used.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G13D • KRAS G13
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    2d
    EMB-01 in Combination With Chemotherapy for Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=120, Not yet recruiting, Shanghai EpimAb Biotherapeutics Co., Ltd.
    New P1 trial
    |
    5-fluorouracil • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • bafisontamab (EMB-01)
    4d
    GS-US-741-7756: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults with Advanced Colorectal Cancer. (2025-523984-39-00)
    P1/2, N=94, Not yet recruiting, Gilead Sciences Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • KRAS mutation • KRAS G12C • BRAF V600 • RAS wild-type • KRAS G12
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • denikitug (GS-1811)
    6d
    Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=170, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • denikitug (GS-1811)
    8d
    GS-US-741-7756: Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults with Advanced Colorectal Cancer. (2025-523984-39-00)
    P1/2, N=75, Not yet recruiting, Gilead Sciences Inc.
    New P1/2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
    |
    BRAF V600E • KRAS mutation • KRAS G12C • BRAF V600 • RAS wild-type • KRAS G12
    |
    Opdivo (nivolumab) • Avastin (bevacizumab) • Lonsurf (trifluridine/tipiracil) • denikitug (GS-1811)
    9d
    INTEGRATEIIb: RegoNivo vs Standard of Care Chemotherapy in AGOC (clinicaltrials.gov)
    P3, N=462, Completed, Australasian Gastro-Intestinal Trials Group | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Opdivo (nivolumab) • docetaxel • albumin-bound paclitaxel • Stivarga (regorafenib) • irinotecan • Lonsurf (trifluridine/tipiracil)
    9d
    KEYNOTE-E59: A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors (clinicaltrials.gov)
    P1/2, N=226, Terminated, Astellas Pharma Global Development, Inc. | Active, not recruiting --> Terminated; Lack of clinical benefit
    Trial termination
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
    |
    HER-2 negative • PD-L1 underexpression
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • carboplatin • docetaxel • 5-fluorouracil • pemetrexed • oxaliplatin • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • ASP1570
    22d
    CLARITY-Gastric 01: AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (clinicaltrials.gov)
    P3, N=592, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CLDN18 (Claudin 18)
    |
    CLDN18.2 expression • CLDN18.2 positive • CLDN1 positive
    |
    paclitaxel • docetaxel • AiTan (rivoceranib) • Cyramza (ramucirumab) • irinotecan • Lonsurf (trifluridine/tipiracil) • sonesitatug vedotin (AZD0901)
    27d
    TIBET: TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=52, Completed, Borstkanker Onderzoek Groep | Active, not recruiting --> Completed | Trial completion date: Nov 2025 --> May 2026
    Trial completion • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
    |
    Lonsurf (trifluridine/tipiracil)
    27d
    Matching-Adjusted Indirect Comparison of Sotorasib Plus Panitumumab Versus Trifluridine/Tipiracil Plus Bevacizumab in Chemorefractory Metastatic Colorectal Cancer. (PubMed, Clin Colorectal Cancer)
    In this MAIC analysis, soto960+pani demonstrated statistically significant improvement in response rates and OS in patients with chemorefractory KRAS G12C-mutated mCRC.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • Vectibix (panitumumab) • Lumakras (sotorasib) • Stivarga (regorafenib) • Lonsurf (trifluridine/tipiracil)
    27d
    Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas (clinicaltrials.gov)
    P1, N=411, Recruiting, Inhibrx Biosciences, Inc | Trial completion date: Dec 2026 --> Jun 2029 | Trial primary completion date: Jun 2026 --> Dec 2028
    Trial completion date • Trial primary completion date • First-in-human
    |
    Avastin (bevacizumab) • carboplatin • 5-fluorouracil • temozolomide • pemetrexed • irinotecan • Lonsurf (trifluridine/tipiracil) • leucovorin calcium • ozekibart (INBRX-109)