Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LAG525 · 2 trials · 2 indications
Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment. The 95% CIs were computed using two-sided exact binomial method. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Tumor response was based on local investigator assessment and the assessment criteria was Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). ORR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR). For RECIST v1.1, CR=Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm; PR= At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters. ORR is reported by tumor type.
| Arm | Type | Description |
|---|---|---|
| LAG525 + PDR001 | EXPERIMENTAL | Participants received LAG525 and PDR001 administered as infusion once every 3 weeks |
| LAG525 + PDR001 + carboplatin | EXPERIMENTAL | Participants received LAG525, PDR001 and carboplatin administered as infusion once every 3 weeks. |
| LAG525 + carboplatin | EXPERIMENTAL | Participants received LAG525 and carboplatin administered as infusion once every 3 weeks |
| Phase 1: LAG525 1 mg/kg Q2W | EXPERIMENTAL | Single-agent LAG525 1 mg/kg Q2W |
| Phase 1: LAG525 3 mg/kg Q2W | EXPERIMENTAL | Single-agent LAG525 3 mg/kg Q2W |
| Phase 1: LAG525 5 mg/kg Q2W | EXPERIMENTAL | Single-agent LAG525 5 mg/kg Q2W |
| Phase 1: LAG525 10 mg/kg Q2W | EXPERIMENTAL | Single-agent LAG525 10 mg/kg Q2W |
| Phase 1: LAG525 15 mg/kg Q2W | EXPERIMENTAL | Single-agent LAG525 15 mg/kg Q2W |
| Phase 1: LAG525 240 mg Q2W | EXPERIMENTAL | Single-agent LAG525 240 mg Q2W |
| Phase 1: LAG525 400 mg Q2W | EXPERIMENTAL | Single-agent LAG525 400 mg Q2W |
| Phase 1: LAG525 3 mg/kg Q4W | EXPERIMENTAL | Single-agent LAG525 3 mg/kg Q4W |
| Phase 1: LAG525 5 mg/kg Q4W | EXPERIMENTAL | Single-agent LAG525 5 mg/kg Q4W |
| Phase 1: LAG525 10 mg/kg Q4W | EXPERIMENTAL | Single-agent LAG525 10 mg/kg Q4W |
| Phase 1: LAG525 400 mg Q4W | EXPERIMENTAL | Single-agent LAG525 400 mg Q4W |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | EXPERIMENTAL | Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | EXPERIMENTAL | Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W) |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | EXPERIMENTAL | Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W) |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | EXPERIMENTAL | Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W) |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | EXPERIMENTAL | Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W) |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | EXPERIMENTAL | Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W) |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | EXPERIMENTAL | Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | EXPERIMENTAL | Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W) |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | EXPERIMENTAL | Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W) |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W) |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W) |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W) |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W) |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W) |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W) |
| Phase 2: Naive - LAG525 400 mg Q3W + PDR001 300 mg Q3W | EXPERIMENTAL | Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients naïve to anti-PD-1/PD-L1 |
| Phase 2: Naive - LAG525 600 mg Q4W + PDR001 400 mg Q4W | EXPERIMENTAL | Combination LAG525 600 mg + PDR001 400 mg (Q4W/Q4W) in patients naïve to anti-PD-1/PD-L1 |
| Phase 2: Pre-treated - LAG525 400 mg Q3W + PDR001 300 mg Q3W | EXPERIMENTAL | Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W) in patients pre-treated with anti-PD-1/PD-L1 |
| Name | Type | Description |
|---|---|---|
| LAG525 | DRUG | LAG525 was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 400mg every 21 days. For all arms, LAG525 was infused first |
| PDR001 | DRUG | Spartalizumab was a concentrate for solution for intravenous infusion, came in 100mg vials as a liquid formulation for infusion and was dosed at 300mg every 21 days. Spartalizumab was infused after LAG525 |
| Carboplatin | DRUG | Carboplatin was a concentrate for solution for intravenous infusion, came in 100mg/mL and was dosed per area under the curve (AUC) 6 every 21 days. Carboplatin was infused once LAG525 and spartalizumab infusions were completed |
Inclusion Criteria: * Had advanced (loco-regionally recurrent not amenable to curative therapy or metastatic) breast cancer * Had adequate bone marrow and organ function. * Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Had measurable disease, i.e., at least one mea...
LAG525 is an investigational therapy being studied for advanced solid tumors and triple-negative breast cancer. It has been evaluated in clinical trials as a single agent and in combination with other agents, including spartalizumab and carboplatin, in patients with advanced malignancies. It is not approved for any indication.
LAG525 is a small molecule designed to target LAG-3, an immune checkpoint receptor. By binding to LAG-3, it aims to modulate immune responses against tumor cells. This mechanism is being explored in oncology, particularly in advanced solid tumors and triple-negative breast cancer.
LAG525 is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the New York Stock Exchange under the ticker symbol NVS. The company is responsible for the clinical development of LAG525.
LAG525 is in Phase 1 clinical development. It has been evaluated in a Phase 1 trial and a Phase 2 trial, both of which are completed. The drug remains investigational and has not been approved by the FDA for any indication.
LAG525 has been studied in two completed clinical trials: NCT02460224, a Phase 1 trial in advanced solid tumors with 490 patients, and NCT03499899, a Phase 2 trial in triple-negative breast cancer with 88 patients. Both trials are completed and no active trials are ongoing.