Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lenvatinib · 2 trials · 4 indications
An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the investigator based on medical judgement. A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.
Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments. CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
ORR was defined as the percentage of participants achieving the best overall response (BOR) of complete response (CR) or partial response (PR). The 95% confidence interval (CI) was estimated using the Clopper-Pearson method. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., 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 \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
| Arm | Type | Description |
|---|---|---|
| Safety Run In | EXPERIMENTAL | Participants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D). |
| Part 2: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Cohort | EXPERIMENTAL | Participants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously \[IV\] every 6 weeks \[Q6W\]) in combination with lenvatinib (20 mg taken orally once daily \[QD\]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| Part 2: Renal Cell Carcinoma (RCC) Cohort | EXPERIMENTAL | Systemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination. |
| Part 2: Non-Small Cell Lung Cancer (NSCLC) Cohort | EXPERIMENTAL | Participants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data. |
| Part 2: Gastric Cancer (GC) Cohort | EXPERIMENTAL | Participants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care. |
| Part 2: Urothelial Cancer (UC) Cohort | EXPERIMENTAL | Participants with cisplatin ineligible, systemic therapy naive advanced UC, were to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data. |
| Lenvatinib With Tislelizumab | EXPERIMENTAL | Participants received lenvatinib based on baseline weight (12 milligrams \[mg\] or 8 mg once daily for participants with a baseline weight of \>= 60 kilograms \[kg\] or \< 60 kg, respectively) along with tislelizumab 200 mg on Day 1 of each 21-day cycle (once every 3 weeks) until disease progression, unacceptable toxicity, or withdrawal for other reasons, whichever occurred first. |
| Name | Type | Description |
|---|---|---|
| lenvatinib | DRUG | Administered at the dose of 20 mg orally, once daily. |
| Tislelizumab | DRUG | 400 mg administered intravenously on Day 1 of each 42-day cycle |
Key Inclusion Criteria: 1. Participants had signed an informed consent form and were able to comply with all study requirements. 2. Participants had a histologically and/or cytologically confirmed diagnosis of advanced solid tumors, which included one of the following types: * Non-Small Cell Lu...