Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TG4010 · 2 trials · 7 indications
Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.
Number of patients with a best overall response of CR or PR, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| TG4010/Chemotherapy/Nivolumab | EXPERIMENTAL | - |
| Treatment TG4010 + nivolumab | EXPERIMENTAL | Patients receive TG4010 SC once per week for courses 1-3 and every 2 weeks for courses thereafter and nivolumab IV over 30 minutes every 2 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| TG4010 | BIOLOGICAL | 1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks |
| Chemotherapy | DRUG | Pemetrexed/Cisplatin or Carboplatin Pemetrexed maintenance |
| Nivolumab | DRUG | 360 mg IV administration every 3 weeks |
Principal Inclusion Criteria: * Female or male patients age \> 18 years-old * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at study entry * Life expectancy of at least 3 months * Histologically confirmed non-squamous NSCLC (adenocarcinoma, large cell carcinoma, undiffere...
Top 20 of 84 competitors
TG4010 is an investigational monoclonal antibody being studied for recurrent non-small cell lung carcinoma and metastatic non-small cell lung cancer. It is in Phase 2 clinical development for these oncology indications.
TG4010 is a monoclonal antibody, but its specific molecular target has not been disclosed in available clinical trial information. It is being evaluated in combination with other therapies for non-small cell lung cancer.
TG4010 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug in patients with lung cancer.
TG4010 is in Phase 2 clinical development. Two Phase 2 trials have been completed, one with 13 participants and another with 44 participants, both studying the drug in non-small cell lung cancer.
TG4010 has been studied in two completed Phase 2 trials: NCT02823990, which evaluated TG4010 and nivolumab in lung cancer patients, and NCT03353675, which studied first-line chemotherapy combined with TG4010 and nivolumab in advanced non-squamous NSCLC.
TG4010 is not FDA approved. It is an investigational drug that has completed Phase 2 clinical trials for non-small cell lung cancer, but it remains in clinical development and has not received regulatory approval.