Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Alcestobart
LBL-007 · 2 trials · 4 indications
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 \[NCI-CTCAE v5.0\]).
PFS, as assessed by the investigator per RECIST v1.1 is defined as the time from the date of randomization to the date of first documentation of disease progression or death, whichever occurs first.
| Arm | Type | Description |
|---|---|---|
| LBL-007 | EXPERIMENTAL | LBL-007 in combination with tislelizumab plus chemotherapy doublet. |
| Tislelizumab and Chemotherapy | ACTIVE_COMPARATOR | Tislelizumab plus chemotherapy doublet. |
| Phase 1b: Cohort -1: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine | EXPERIMENTAL | LBL-007 (low dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine |
| Phase 1b: Cohort 1a: LBL-007 + Tislelizumab + Bevacizumab + Capecitabine | EXPERIMENTAL | LBL-007 (medium dose) + tislelizumab (low dose once every 3 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks) + capecitabine |
| Phase 1b: Cohort 1b: LBL-007 + Tislelizumab + Bevacizumab + 5-Fluorouracil (5-FU) | EXPERIMENTAL | LBL-007 (medium dose) + tislelizumab (high dose once every 4 weeks) + bevacizumab (5 mg/kg once every 2 weeks) + 5-FU |
| Phase 1b: Cohort 2: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm A and Arm D: LBL-007 + Tislelizumab + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + tislelizumab (low dose every 3 weeks or high dose every 4 weeks) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm B: LBL-007 + Bevacizumab + Fluoropyrimidine | EXPERIMENTAL | LBL-007 (high dose) + bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Phase 2: Arm C and Arm E: Bevacizumab + Fluoropyrimidine | ACTIVE_COMPARATOR | Bevacizumab (7.5 mg/kg once every 3 weeks or 5 mg/kg once every 2 weeks) + fluoropyrimidine (5-FU or capecitabine) |
| Name | Type | Description |
|---|---|---|
| LBL-007 | DRUG | LBL-007 will be administered at a standard dose intravenously. |
| Tislelizumab | DRUG | Tislelizumab will be administered at a standard dose intravenously. |
| Chemotherapy Doublet | DRUG | Doublet 1: cisplatin + 5-fluorouracil Doublet 2: cisplatin + paclitaxel Choice of chemotherapy doublet will be determined by the investigator and will be administered at standard doses intravenously. |
| Bevacizumab or Bevacizumab biosimilar | DRUG | Administered intravenously |
| Capecitabine | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information |
| 5-Fluorouracil | DRUG | Administered in accordance with relevant local guidelines and/or prescribing information |
Inclusion Criteria: * Able to provide written informed consent and can agree to comply with the study requirements. * Participants with metastatic ESCC or unresectable, locally advanced ESCC. * Histologically confirmed diagnosis of ESCC. * Can provide a tumor sample. * At least 1 measurable lesion ...
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LBL-007 is an investigational small molecule developed by BeOne Medicines Ltd. (ticker ONC). It is being studied in oncology as a LAG-3 targeted agent, both in esophageal cancer and in unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer. It is currently in Phase 2 clinical development.
LBL-007 is being evaluated for the treatment of esophageal cancer, including esophageal squamous cell carcinoma, and for unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer. It is an investigational therapy and is not approved for any indication.
LBL-007 targets LAG-3, a protein immune checkpoint receptor. By binding LAG-3, the drug is designed to modulate an inhibitory pathway that suppresses T cell activity. In clinical studies it is given in combination with tislelizumab, an anti-PD-1 antibody, with or without chemotherapy or bevacizumab plus fluoropyrimidine.
LBL-007 is developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is running the clinical program for the asset across sites in China, South Korea, Taiwan, Thailand, the United States, Australia, and Puerto Rico.
LBL-007 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The Phase 2 study in esophageal squamous cell carcinoma has completed, while a Phase 1 colorectal cancer study remains active but is no longer recruiting.
LBL-007 has been studied in two registered trials. NCT06010303 is a completed Phase 2 study of LBL-007 plus tislelizumab and chemotherapy in unresectable locally advanced or metastatic esophageal squamous cell carcinoma, enrolling 118 participants. NCT05609370 is an active Phase 1 study in unresectable or metastatic microsatellite stable/mismatch repair proficient colorectal cancer, enrolling 113 participants.