Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tislelizumab · 39 trials · 51 indications
DFS (tumor-specific) is defined as time from randomization to tumor relapse or tumor-related death. DFS will be compared between treatment arms using the stratified log rank test at one-sided level 0.025. If zero DFS events are observed in a certain stratum at an interim analysis and unstratified log-rank is used, all subsequent analyses for DFS will use unstratified log-rank test.
Safety as assessed by the number of participants with immune-mediated adverse events (imAEs), ≥ Grade 3 adverse events, and serious adverse events.
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
PFS is defined as the time from randomization to the first documented disease progression, as determined by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death from any cause, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, and/or unequivocal progression of existing nontarget lesions. or the appearance of one or more new lesions.
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS.
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first
PFS is defined as the time from randomization until first documentation of disease progression as assessed by the IRC per RECIST v1.1 or death from any cause, whichever occurs first
PFS is defined as the time from randomization until first documentation of progression or death from any cause, whichever occurs first, as assessed by the IRC per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent severe outcomes).
Serum concentration of tislelizumab was a pre-specified primary endpoint for the sub-study only.
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology. Overall survival was a pre-specified primary endpoint for the main study only.
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
OS was defined as the time from randomization to death from any cause. Median OS was calculated using the Kaplan-Meier method. Data for participants who were not reported as having died at the time of analysis were censored at the date they were last known to be alive. Data for participants who did not have postbaseline information were censored at the date of randomization.
Estimated 2-year OS rate is defined as number of participants alive divided by the number of participants.
The change in density of intratumoral granzyme B+ CD137+ T cells before and after neoadjuvant treatment with tislelizumab and SX-682.
The number of patients with a grade 0-2 pathologic response as defined by the College of American Pathologists (CAP) tumor regression grading system.
ORR is defined as the proportion of patients with at least one visit response of complete response (CR) or partial response (PR) that is confirmed at least 4 weeks later according to Response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
Proportion of patients achieving a pathCR in the surgical specimen after perioperative biomarker-directed systemic therapy.
Proportion of patients able to avoid surgery and preserve the affected organ due to biomarker-driven treatment response.
Number of participants Adverse events (AEs) and serious adverse events (SAEs) as characterized by type, frequency, severity (National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAEv5.0\]\[1\]), timing, seriousness, and relationship to study treatment in GAC/GEA and ESCC participants, respectively
Tumor tissue and lymph node tissue obtained from surgical resection were sent to a central laboratory according to study pathology manuals for pathological response analysis. MPR rate is defined as the percentage of participants with ≤ 10% residual viable tumor in the resected primary tumor and all resected lymph nodes as assessed by blinded independent pathology review (BIPR). Participants without surgery or pathological results were considered non-responders.
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.
A DLT was defined as 1 of the following toxicities (Grade 3 or 4 Hematologic or Nonhematologic toxicities) occurring during the DLT assessment window and considered by the investigator to be related to 1 or more study drugs. All toxicities or adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0).
RP2D for Part 2 was determined by evaluating safety and DLTs in Part 1 participants.
ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). Per RECIST v1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Objective response rate is defined as the percentage of participants who had a best overall response of confirmed complete response (CR) or partial response (PR) assessed by the Investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Response evaluations were performed using computed tomography or magnetic resonance imaging (MRI) approximately every 6 weeks for the first 54 weeks and then every 12 weeks thereafter. CR: Disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) \< 10 mm, and no new lesions. PR: At least a 30% decrease in the size of target lesions, with no progression of non-target lesions and no new lesions, or disappearance of target lesions with persistence of 1 or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions. Response (CR or PR) must have been confirmed 4 weeks or later after the first response was observed.
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) as assessed by the IRC per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1). PD-L1-positive refers to participants whose tumors had a PD-L1 TAP score ≥ 5%.
ORR is defined as the percentage of participants who had a confirmed CR or PR as assessed by the IRC per RECIST v1.1.
ORR was defined as the percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) by Positron Emission Tomography (PET) and Computed Tomography (CT) per the Lugano Classification and as determined by the investigator. CR was defined as the complete disappearance of all target lesions on PET-CT, with no new lesions detected. PR was defined as a significant reduction in metabolic activity or lesion size consistent with partial tumor shrinkage as per Lugano criteria.
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by Independent Review Committee (IRC) using RECIST version 1.1
Number of participants with AEs and SAEs and laboratory abnormalities, reported during the AE reporting period and characterized by type, frequency, severity (as graded by National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0 \[NCI-CTCAE v5.0\]), timing, seriousness, and relationship to study therapy.
Number of participants with adverse events (AEs) and serious adverse events (SAEs), as defined per NCI-CTCAE Version 4.03, including physical examination, electrocardiograms and laboratory assessments
Recommended dose of tislelizumab for indication cohorts based on safety and tolerability
Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated
Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter final manufacturing process (FMP) were evaluated
Pharmacokinetics from products derived from two manufacturing scales at 500 liter and 2000 liter FMP were evaluated
Objective response rate (ORR) is defined as the percentage of participants who achieved objective tumor response (complete response or partial response) according to RECIST Version 1.1. Indication expansion includes participants from all parts in the following indications: non-small cell lung cancer (NSCLC), melanoma, esophageal squamous cell carcinoma (ESCC), gastric cancer (GC), urothelial carcinoma (UC), nasopharyngeal carcinoma (NPC), renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, and other tumor types.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
DLT was defined as an AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and occurs during the first 21 days following the first dose of tislelizumab and pamiparib in Cycle 1 and meets protocol-specified criteria. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
ORR was defined as the percentage of participants with a best overall response of complete response (CR) and partial response (PR).
PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.
DOR, defined as the time from the first determination of an objective response, was assessed by investigator per Response Evaluation Criteria in Solid Tumors v1.1 until the first documentation of progression or death, whichever occurred first. Results are reported only for arms with responders.
DCR was defined as the percentage of participants with a best overall response of CR, PR, and stable disease (SD).
CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.
OS was defined as the time from the date of first dose of study drug to death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Tislelizumab Arm | EXPERIMENTAL | Two cycles of Tislelizumab 200mg intravenously, on day 1 and day 22, with or without adjuvant chemotherapy |
| Control Arm | ACTIVE_COMPARATOR | Receiving standard of Care (either with adjuvant chemotherapy or surveillance alone). |
| Arm A: Tislelizumab Subcutaneous + Chemotherapy | EXPERIMENTAL | Participants will receive tislelizumab 300 mg subcutaneous (SC) injection on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis. |
| Arm B: Tislelizumab Intravenous Infusion + Chemotherapy | ACTIVE_COMPARATOR | Participants will receive tislelizumab 200 mg intravenous infusion (IV) on Day 1 of each 21-day cycle, followed by chemotherapy decided on an individual patient basis. |
| Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab | EXPERIMENTAL | Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium |
| Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo | PLACEBO_COMPARATOR | Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium |
| A - Tislelizumab Monotherapy | EXPERIMENTAL | - |
| B - Pamiparib Monotherapy | EXPERIMENTAL | - |
| C - Sitravatinib Monotherapy | EXPERIMENTAL | - |
| D - BGB-15025 Monotherapy | EXPERIMENTAL | - |
| E - Zanidatamab Monotherapy | EXPERIMENTAL | - |
| F - Pamiparib and Temozolomide Combination Therapy | EXPERIMENTAL | - |
| G - Tislelizumab and Pamiparib Combination Therapy | EXPERIMENTAL | - |
| H - Tislelizumab and Sitravatinib Combination Therapy | EXPERIMENTAL | - |
| I - Tislelizumab and Ociperlimab Combination Therapy | EXPERIMENTAL | - |
| J - Tislelizumab and BAT1706 Combination Therapy, or BAT1706 Monotherapy | EXPERIMENTAL | - |
| K - Tislelizumab and Fruquintinib Combination Therapy | EXPERIMENTAL | - |
| L - Tislelizumab and BGB-A445 Combination Therapy | EXPERIMENTAL | - |
| M - Tislelizumab and Surzebiclimab Combination Therapy | EXPERIMENTAL | - |
| N - Tislelizumab and BGB-15025 Combination Therapy | EXPERIMENTAL | - |
| O - Tislelizumab and Lenvatinib Combination Therapy | EXPERIMENTAL | - |
| P - Tislelizumab and Zanidatamab Combination Therapy | EXPERIMENTAL | - |
| Q - Tislelizumab and LBL-007 Combination Therapy | EXPERIMENTAL | - |
| R - Tislelizumab and Surzebiclimab and LBL-007 Combination Therapy | EXPERIMENTAL | - |
| Arm A: Tislelizumab + Chemotherapy | EXPERIMENTAL | Participants received tislelizumab in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, administered every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with tislelizumab only, administered once every 3 weeks. |
| Arm B: Placebo + Chemotherapy | PLACEBO_COMPARATOR | Participants received a placebo in combination with either cisplatin or carboplatin (at the investigator's discretion) and etoposide during the induction phase, given every 3 weeks for 4 cycles. Upon completion of the induction phase, participants transitioned to maintenance therapy with placebo only, administered once every 3 weeks. |
| Tislelizumab + Chemoradiotherapy | EXPERIMENTAL | Participants received 200 mg tislelizumab administered intravenously (IV) once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by 200 mg tislelizumab for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
| Placebo + Chemoradiotherapy | PLACEBO_COMPARATOR | Participants received placebo IV once every 3 weeks in combination with concurrent chemoradiotherapy (CRT) for up to approximately 6 weeks followed by placebo for a total of up to 24 months (about 35 cycles), or until disease progression, unacceptable toxicity, withdrawal of consent, or another treatment discontinuation criterion was met, whichever occurred first. Concurrent chemotherapy consisted of cisplatin (25 mg/m² IV; Days 1-3 of each 3-week cycle) in combination with paclitaxel (135 mg/m² IV; Day 1 of each 3-week cycle) and radiotherapy was delivered in 28 fractions (total dose, 50.4 Gy). |
| Tislelizumab in combination with chemotherapy | ACTIVE_COMPARATOR | Tislelizumab: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles |
| Placebo in combination with chemotherapy | PLACEBO_COMPARATOR | Placebo: Day 1 of each 21-day cycle, to be administered until Progressive Disease or intolerable toxicity Cisplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Carboplatin: Day 1 or Day 2 of each 21-day cycle, to be administered up to 6 cycles Gemcitabine: Days 1 and 8 of each 21-day cycle, to be administered up to 6 cycles |
| Arm A: Tislelizumab + Gemcitabine + Cisplatin | EXPERIMENTAL | Participants received tislelizumab 200 mg intravenously (IV) once every 3 weeks (Q3W), gemcitabine 1 g/m\^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m\^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have continued to receive tislelizumab monotherapy. |
| Arm B: Placebo + Gemcitabine + Cisplatin | PLACEBO_COMPARATOR | Participants received placebo IV once every 3 weeks, gemcitabine 1 g/m\^2 IV on days 1 and 8 of each 21-day cycle and cisplatin 80 mg/m\^2 IV on day 1 of each cycle for 4 to 6 treatment cycles. Participants may have received treatment for longer at the Investigator's discretion until disease progression. Participants with confirmed disease progression may have crossed over to receive tislelizumab 200 mg IV Q3W monotherapy. |
| Tislelizumab + Chemotherapy | EXPERIMENTAL | Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-fluorouracil (5-FU) on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| Placebo + Chemotherapy | PLACEBO_COMPARATOR | Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Chemotherapy consisted of 1000 mg/m² capecitabine twice daily on Days 1-14 and 130 mg/m² oxaliplatin on Day 1, or 800 mg/m² 5-FU on Days 1-5 and 80 mg/m² cisplatin on Day 1 of each 21-day cycle. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity. |
| Tislelizumab + Paclitaxel + Carboplatin | EXPERIMENTAL | Tislelizumab 200 milligrams (mg) plus paclitaxel 175 mg/m\^2 and carboplatin area under the plasma or serum concentration-time curve (AUC) 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) |
| Tislelizumab + Nab-paclitaxel + Carboplatin | EXPERIMENTAL | Tislelizumab 200 mg on Day 1 plus Nab-paclitaxel 100 mg/m\^2 on Days 1, 8, and 15 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, loss of clinical benefit, or disease progression; Nab-paclitaxel and carboplatin were administered for 4 to 6 cycles (each cycle is 21 days) |
| Paclitaxel + Carboplatin | ACTIVE_COMPARATOR | Paclitaxel 175 mg/m\^2 and carboplatin AUC 5 on Day 1 administered intravenously once every 3 weeks for 4 to 6 cycles (each cycle is 21 days) |
| Tislelizumab + Platinum + Pemetrexed | EXPERIMENTAL | Tislelizumab 200 milligrams (mg) administered intravenously (IV) once every 3 weeks plus cisplatin 75 mg/m\^2 or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days) |
| Platinum + Pemetrexed | ACTIVE_COMPARATOR | Cisplatin 75 mg/m\^2 or carboplatin AUC 5 once every 3 weeks for 4 to 6 cycles and pemetrexed 500 mg/m\^2 administered IV once every 3 weeks until unacceptable toxicity or disease progression (each cycle is 21 days) |
| Tislelizumab | EXPERIMENTAL | Tislelizumab on Day 1, given every 21 days |
| Investigator chosen chemotherapy (ICC) | ACTIVE_COMPARATOR | Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days |
| Safety Run-In Sub-study | EXPERIMENTAL | Japanese participants received 200 mg intravenous tislelizumab every 3 weeks to assess preliminary safety and tolerability. |
| Arm A: Tislelizumab | EXPERIMENTAL | Participants received 200 mg of intravenous tislelizumab every 3 weeks until intolerable toxicity, withdrawal of consent, or the investigator determined no further benefit from the therapy. |
| Arm B: Sorafenib | ACTIVE_COMPARATOR | Participants received 400 mg of oral sorafenib twice daily until intolerable toxicity, consent withdrawal, or the investigator deemed no further benefit. |
| Docetaxel | ACTIVE_COMPARATOR | Participants received docetaxel 75 mg/m² IV once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| Arm 1 | EXPERIMENTAL | Single-arm study: Participants will receive Tislelizumab in combination with chemoradiotherapy (Paclitaxel + Cisplatin) and conversion surgery if the tumor becomes resectable. The treatment sequence involves induction chemoradiotherapy, followed by consolidation chemotherapy and surgery if applicable. |
| Arm A - Tislelizumab and SX-682 | EXPERIMENTAL | - |
| Experimental arm | EXPERIMENTAL | Patients will receive Sitravatinib 100 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until progression of disease, unacceptable toxicity, death, or consent withdrawal, whichever occurs first. Treatment may be continued after progression according to physician criteria (with previous consultation with Coordinating investigator) until patients no longer receive clinical benefit. |
| Zanidatamab + Tislelizumab (HER2) Sub-Study | EXPERIMENTAL | Patients will receive zanidatamab on Day 1 of each 14-day cycle, followed by tislelizumab and mFOLFOX6 chemotherapy: leucovorin (Day 1), oxaliplatin (Day 1), and 5-FU as a 48-hour continuous intravenous infusion (Days 1-2). Up to 8 preoperative cycles will be given, followed by surgery or organ preservation if a complete response is achieved. Post-surgery or organ preservation, zanidatamab + tislelizumab will continue every 2 weeks for up to 1 year of perioperative therapy. |
| Gastric / Gastroesophageal Adenocarcinoma (GAC/GEA) | EXPERIMENTAL | Participants will receive tislelizumab (either 200 mg every 3 weeks or 150 mg every 2 weeks, matching the chemotherapy regimen) and one of the following chemotherapy regimens: * FOLFOX: oxaliplatin 85 mg + leucovorin on Day 1, followed by 5-fluorouracil (5-FU) (2400 to 2800 mg) IV, repeated every 2 weeks (Q2W). * CAPOX: oxaliplatin 130 mg Day 1 + capecitabine 1000 mg orally twice daily for consecutive 14 days, repeated every 3 weeks (Q3W). * Cisplatin 80 mg Day 1 + 5-FU 800 mg IV continuous infusion over 24 hours daily on Day 1 to Day 5, repeated Q3W. |
| Esophageal Squamous Cell Carcinoma (ESCC) | EXPERIMENTAL | Participants will receive tislelizumab 150 mg Q2W and FOLFOX chemotherapy. |
| Tislelizumab + BGB-A425 | EXPERIMENTAL | Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 |
| Tislelizumab + LBL-007 | EXPERIMENTAL | Tislelizumab 200 mg administered once every 3 weeks with LBL-007 |
| Tislelizumab + BGB-A425 + LBL-007 | EXPERIMENTAL | Tislelizumab 200 mg administered once every 3 weeks with BGB-A425 and LBL-007 |
| Arm 1A: Tislelizumab Monotherapy | EXPERIMENTAL | Participants with tumor programmed death protein ligand-1 (PD-L1) expression ≥ 50% received 200 mg tislelizumab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. |
| Arm 1B: Tislelizumab + Ociperlimab | EXPERIMENTAL | Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 900 mg ociperlimab intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. |
| Arm 1C: Alcestobart + Tislelizumab | EXPERIMENTAL | Participants with tumor PD-L1 expression ≥ 50% received 200 mg tislelizumab and 600 mg alcestobart intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. |
| Arm 2A: Tislelizumab and Chemotherapy | EXPERIMENTAL | Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. |
| Arm 2C: Alcestobart + Tislelizumab + Chemotherapy | EXPERIMENTAL | Participants with tumor PD-L1 expression \< 50% received 200 mg tislelizumab, 600 mg alcestobart and chemotherapy consisting of cisplatin or carboplatin with either pemetrexed or paclitaxel administered intravenously once every 3 weeks for 2-4 cycles followed by surgical removal of the tumor. |
| Sub-study 1: Arm 1A | EXPERIMENTAL | Tislelizumab + BGB-A445 |
| Sub-study 1: Arm 2A | EXPERIMENTAL | Tislelizumab + LBL-007 |
| Sub-study 1: Arm 3A | EXPERIMENTAL | Tislelizumab + BGB-15025 |
| Sub-study 1: Reference Arm Tislelizumab alone | ACTIVE_COMPARATOR | Tislelizumab alone |
| Sub-study 2: Arm 1B | EXPERIMENTAL | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 |
| Sub-study 2: Arm 2B | EXPERIMENTAL | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 |
| Sub-study 2: Arm 3B | EXPERIMENTAL | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 |
| Sub-study 2: Reference Arm | ACTIVE_COMPARATOR | Tislelizumab + investigator's choice of histology-appropriate chemotherapy |
| Cohort A (Responder) | EXPERIMENTAL | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in positron emission tomography (PET) Standardized Uptake Value (SUV)max ≥ 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and chemotherapy doublet (cisplatin + paclitaxel) for 2 cycles. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| Cohort B (Non-responder) | EXPERIMENTAL | Participants received induction therapy of one 21-day cycle with cisplatin and paclitaxel administered on Day 1. Following the induction phase, participants with a decrease in PET SUVmax \< 35% then received neoadjuvant therapy consisting of 200 mg tislelizumab on Day 1 of each 21-day cycle for 3 cycles and investigator-chosen chemotherapy doublet (paclitaxel + cisplatin or 5-fluorouracil + cisplatin) for 2 cycles plus concurrent radiotherapy. After neoadjuvant treatment, participants were assessed for disease resectability and underwent surgical resection of the tumor approximately 4 to 6 weeks later. |
| Gastric Cancer (GC): Tislelizumab and Fruquintinib | EXPERIMENTAL | Participants with advanced or metastatic, unresectable GC received fruquintinib 5 milligrams (mg) daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| Colorectal Cancer (CRC): Tislelizumab and Fruquintinib | EXPERIMENTAL | Participants with advanced or metastatic, unresectable CRC received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| PD-L1 + NSCLC: Tislelizumab and Fruquintinib | EXPERIMENTAL | Participants with programmed cell death protein ligand-1 (PD-L1) expression, and advanced or metastatic, unresectable non-small cell lung cancer (NSCLC) received fruquintinib 5 mg daily (3 weeks receiving fruquintinib followed by 1 week off) in combination with tislelizumab 300 mg intravenously on Day 1 of every 4-week cycle (each cycle of 28-days) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| Arm A: Tislelizumab plus Ociperlimab | EXPERIMENTAL | Participants received 200 milligrams (mg) tislelizumab plus 900 mg ociperlimab intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| Arm B: Tislelizumab plus Placebo | PLACEBO_COMPARATOR | Participants received 200 mg tislelizumab plus placebo intravenously once every 3 weeks until disease progression, unacceptable toxicity, or withdrawal of informed consent, whichever occurred first. |
| Cohort 1: Ociperlimab + Tislelizumab | EXPERIMENTAL | Tislelizumab 200 milligrams (mg) intravenously (IV) once every 3 weeks (Q3W) combined with ociperlimab (BGB-A1217) 900 mg IV Q3W |
| Cohort 2: Tislelizumab | EXPERIMENTAL | Tislelizumab 200 mg IV Q3W monotherapy |
| Cohort 1 | EXPERIMENTAL | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression following autologous hematopoietic stem cell transplantation received tislelizumab 200 milligrams (mg) intravenously every 3 weeks. |
| Cohort 2 | EXPERIMENTAL | Participants who had relapsed or refractory classical Hodgkin lymphoma and had either not achieved a response or had disease progression after at least one prior systemic therapy and were not candidates for autologous or allogeneic hematopoietic stem cell transplantation received tislelizumab 200 mg intravenously every 3 weeks. |
| Tislelizumab (BGB-A317) Injection | EXPERIMENTAL | - |
| Cohort 1: ENKTL | EXPERIMENTAL | Participants with relapsed or refractory (R/R) extranodal natural killer-/T-cell lymphoma (ENKTL; nasal or non-nasal type) were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) |
| Cohort 2: PTCL-NOS, AITL, and ALCL | EXPERIMENTAL | Participants with other R/R mature T-cell neoplasms \[limited to peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), and anaplastic large-cell lymphoma (ALCL)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) |
| Cohort 3: MF and SS | EXPERIMENTAL | Participants with R/R cutaneous T-cell lymphoma \[limited to mycosis fungoides (MF) and Sèzary syndrome (SS)\] were treated with tislelizumab 200 mg intravenously (IV) on Day 1 of each cycle until disease progression, intolerable toxicity, or treatment discontinuation for any other reason (21 days per cycle) |
| Non-squamous NSCLC | EXPERIMENTAL | Day 1 of each 21-day (3 weeks) cycle: Tislelizumab + pemetrexed + cisplatin 75 mg/m²/day IV (or carboplatin AUC 5). Pemetrexed plus cisplatin (or carboplatin) should be given for up to 4 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. Pemetrexed maintenance after completion of doublet chemotherapy is permitted. |
| Squamous NSCLC Cohort A | EXPERIMENTAL | Tislelizumab every 3 weeks (Q3W) + paclitaxel + cisplatin (or carboplatin), Q3W. Paclitaxel plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
| Squamous NSCLC Cohort B | EXPERIMENTAL | Tislelizumab Q3W on Day 1 + gemcitabine on Day 1 and Day 8 + cisplatin IV (or carboplatin) on Day 1. Gemcitabine plus cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
| SCLC | EXPERIMENTAL | Tislelizumab Q3W on Day 1, etoposide on Days 1, 2, and 3 + cisplatin (or carboplatin) on Day 1. Etoposide and cisplatin (or carboplatin) will be administered for 4-6 cycles. Following either completion of or discontinuation from chemotherapy, tislelizumab will be continued as scheduled, if clinically appropriate. |
| Gastric (GC) and Gastroesophageal Junction (GEJ) Carcinoma | EXPERIMENTAL | - |
| Part 1: Dose/Injection Site Exploration | EXPERIMENTAL | Different injection sites will be evaluated; participants will receive tislelizumab in predefined administration sequences plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype. |
| Part 2: Dose Expansion | EXPERIMENTAL | The recommended dose of tislelizumab SC determined from Part 1 plus histology-based chemotherapy consisting of either cisplatin/carboplatin and pemetrexed or carboplatin and paclitaxel/nab-paclitaxel depending on the cancer subtype will be evaluated. |
| Part A: Dose Escalation Phase | EXPERIMENTAL | Participants received tislelizumab and pamiparib (dose escalation) until determination of the maximum tolerated dose/recommended Phase 2 dose. |
| Part B: Dose Expansion Phase | EXPERIMENTAL | Participants received tislelizumab and pamiparib (dose expansion). |
| Name | Type | Description |
|---|---|---|
| Tislelizumab | DRUG | \- Tislelizumab 200mg (day 1 and day 22), administered after surgery |
| Adjuvant chemotherapy | DRUG | * Adjuvant therapy is not mandatory. * Optional adjuvant regimens include FOLFOX, CapeOX, 5-FU+LV, or Capecitabine. |
| Subcutaneous Tislelizumab | DRUG | Administered by subcutaneous injection |
| Intravenous Tislelizumab | DRUG | Administered by intravenous infusion |
| Cisplatin | DRUG | Administered by intravenous infusion |
| Leucovorin | DRUG | Administered by intravenous infusion |
| 5-fluorouracil (5-FU) | DRUG | Administered by intravenous infusion |
| Oxaliplatin | DRUG | Administered by intravenous infusion |
| Capecitabine | DRUG | Administered orally |
| Cisplatin injection | DRUG | administered via IV infusion |
| Paclitaxel injection | DRUG | administered via IV infusion |
| Pemetrexed Disodium | DRUG | administered via IV infusion |
| Placebos | DRUG | Placebo to match tislelizumab IV infusion |
| Carboplatin | DRUG | administered via IV infusion |
| Pamiparib | DRUG | Administered orally. |
| Temozolomide | DRUG | Administered orally. |
| Sitravatinib | DRUG | Administered orally. |
| Ociperlimab | DRUG | Administered intravenously. |
| BAT1706 | DRUG | Administered intravenously. |
| Fruquintinib | DRUG | Administered orally. |
| BGB-15025 | DRUG | Administered orally. |
| Zanidatamab | DRUG | Administered intravenously. |
| BGB-A445 | DRUG | Administered intravenously. |
| Surzebiclimab | DRUG | Administered intravenously. |
| Lenvatinib | DRUG | Administered orally. |
| LBL-007 | DRUG | Administered intravenously. |
| Etoposide | DRUG | 100 mg/m² was administered intravenously from Day 1 to Day 3 of each 21-day cycle, infused over a duration of 60 minutes. Treatment with etoposide was discontinued starting in Cycle 5 and beyond. |
| Placebo | DRUG | 200 mg was administered intravenously on Day 1 of each 21-day cycle to match tislelizumab. |
| Paclitaxel | DRUG | Administered as 135 mg/m² IV injection |
| Radiotherapy | RADIATION | Administered at a total dose of 50.4 Gy in 28 fractions |
| Gemcitabine Hydrochloride | DRUG | 1000 mg/m2 administered IV as specified in the treatment arm |
| Gemcitabine | DRUG | 1 gram per square meter of body surface area (g/m\^2) on Day 1 and day 8 of each cycle, administered as an IV infusion within 30 minutes, for 4 to 6 cycles |
| 5-Fluorouracil | DRUG | 800 mg/m²/day IV using continuous infusion on Days 1 to 5 of each 21-day cycle |
| Fluorouracil (5-FU) | DRUG | Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle. |
| Nab-paclitaxel | DRUG | Administered intravenously as described |
| Pemetrexed | DRUG | Administered intravenously |
| Docetaxel | DRUG | 75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan |
| Irinotecan | DRUG | 125 mg/m\^2 administered IV |
| Sorafenib | DRUG | Sorafenib 400 mg orally (PO) twice daily (BID) |
| Radiation Therapy | RADIATION | 1\. ICRT phase -Tislelizumab and CRT regimen Radiotherapy treatment: IMRT 41-50.4Gy, a dose of 1.8 to 2Gy per day, 5 days per week for 5 weeks during the RT phase. |
| SX-682 | DRUG | Patients will receive SX-682 (200 mg twice daily by mouth) on Days 1-14 of Cycles 1-2 and Days 1-21 of Cycles 3-6. Cycle 1 will be 14 days long and occur prior to surgery. Cycle 2 will be 14 days long and occur prior to standard of care chemotherapy. Cycles 3-6 will each be 21 days long and will be given after completion of standard of care chemotherapy. |
| Sitravatinib Malate | DRUG | 100 mg orally once daily |
| Fluorouracil | DRUG | 2,400 mg/m² every 2 weeks for 4 months pre-operatively and up to 8 months post-operatively |
| BGB-A425 | DRUG | Administered intravenously |
| Alcestobart | DRUG | Administered as an intravenous infusion once every 3 weeks |
| Nab paclitaxel | DRUG | Investigator's choice; administered by intravenous infusion |
| Surgical resection | PROCEDURE | Performed as indicated in the treatment arm. |
| Tislelizumab (BGB-A317) | DRUG | Anti-PD-1 Antibody |
| 5-FU | DRUG | Subjects will be treated with 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. 5-FU will be given for up to 6 cycles. |
| Tislelizumab IV | DRUG | Planned doses will be administered intravenously. |
| Tislelizumab SC | DRUG | Planned doses will be administered via subcutaneous injection. |
| Histology-Based Chemotherapy Doublet | DRUG | Chemotherapy Doublet 1: Cisplatin/carboplatin + pemetrexed. Chemotherapy Doublet 2: Carboplatin + paclitaxel/nab-paclitaxel. Choice of histology-based induction chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously. |
Inclusion Criteria: * dMMR and/or MSI-H colorectal carcinoma that undergo surgical resection * Pathologically confirmed as stage II (T3-4,N0), with at least one of the following risk factors: 1) T4 (including T4a and T4b); 2) Vascular invasion; 3) Perineural invasion; 4) Poor differentiation (inclu...
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