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Tislelizumab

A Chinese-developed PD-1 blocker, engineered to avoid a side-channel that may blunt other PD-1 drugs, now approved in the US and EU for oesophageal and stomach cancer.

Humanised IgG4 with an Fc engineered to minimise FcγR binding (reducing macrophage-mediated T-cell clearance). US approvals: second-line ESCC (March 2024), first-line HER2-negative gastric/GEJ with chemotherapy (December 2024, RATIONALE-305), first-line ESCC PD-L1 ≥1% with chemotherapy (March 2025, RATIONALE-306). Also the PD-1 partner in HERIZON-GEA-01 with zanidatamab. Approved in China across many indications since 2019.

Schematic of the modality · Monoclonal antibody (anti-PD-1) · not a molecule; see the Immune checkpoint inhibitors page
How it works, step by step · animated schematic, not to scale
Immune checkpoint inhibitors
Mechanism, step by step
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1.Tislelizumab binds PD-1 on exhausted T cells

Modality
Monoclonal antibody (anti-PD-1)
Mechanism
PD-1 blockade with reduced Fcγ receptor engagement.
Brand / code
Tevimbra · BGB-A317
Dosing & schedule
Route
Intravenous
Schedule
200 mg every 3 weeks
Dose modifications
Withhold or discontinue for immune-related adverse events per label
Monitoring
Thyroid, liver, glucose; immune-related toxicity

Source: www.drugs.com/history/tevimbra.html. Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved (oesophageal and gastric cancers); newer entrant with lower US uptake.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
MHRA-licensed 2024 for oesophageal squamous cell carcinoma; NICE appraisals for ESCC and NSCLC were in progress or recently published. Check NICE.

Sources: NICE search: tislelizumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. Mar 2024ApprovalUS

    Second-line ESCC (RATIONALE-302)

  2. Dec 2024ApprovalUS

    First-line gastric/GEJ (RATIONALE-305)

  3. 4 Mar 2025ApprovalUS

    First-line ESCC PD-L1 ≥1% (RATIONALE-306)

Approvals

RegionYearIndication
China2019Classical Hodgkin lymphoma (first); subsequently urothelial, NSCLC, HCC, ESCC, gastric, nasopharyngeal
US2024Second-line ESCC after chemotherapy; first-line HER2-negative gastric/GEJ with chemotherapy (PD-L1 ≥1)
US2025First-line ESCC, PD-L1 ≥1%, with platinum chemotherapy

Safety

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Toxicity profile
Adverse event
Immune-related adverse events (thyroiditis, pneumonitis, colitis, hepatitis)
Rash, fatigue

Class effects of PD-1 blockade. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
636 studies34 recruiting86 Phase 216 Phase 3
Search “Tislelizumab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Tislelizumab
intervention: Tislelizumab
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend345 papers in the last 12 months+31% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Tislelizumab" OR ABSTRACT:"Tislelizumab" OR TITLE:"Tevimbra" OR ABSTRACT:"Tevimbra" OR TITLE:"BGB-A317" OR ABSTRACT:"BGB-A317") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Tislelizumab, not a curated reading list.

Connected

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