Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ivonescimab, Ivonescimab, Ivonescimab Injection, Drug: Ivonescimab Injection, Drug: Ivonescimab
Ivonescimab/kg · 2 trials · 2 indications
the time from the date of randomization to the date of death from any cause. Patients still alive at the time of analysis will be censored at the date of their last known alive date
Overall Response Rate (ORR) defined as the proportion of participants achieving complete response (CR) or partial response (PR) as best response on treatment based on RECIST v1.1 criteria at each dose level.
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definite based on Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE V5.0) that are not resolved in accordance with treatment guidelines will be counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
| Arm | Type | Description |
|---|---|---|
| Bras A: Ivonescimab | EXPERIMENTAL | Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W) |
| Bras B: Ivonescimab - Ligufalimab | EXPERIMENTAL | Ivonescimab (10 mg/kg iv, 60 min ± 10 min infusion, Q3W), and ligufalimab (45 mg/kg iv, 120 min ± 15 min infusion, Q3W). |
| Bras C: Pembrolizumab | ACTIVE_COMPARATOR | Pembrolizumab (200 mg iv, 60 min ± 10 min infusion, Q3W). |
| Arm A: Ivonescimab 10 mg/kg | EXPERIMENTAL | Induction with ivonescimab 10 mg/kg, carboplatin and etoposide every 21 days x 4 cycles followed by maintenance ivonescimab 10 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction. |
| Arm B: Ivonescimab 20 mg/kg | EXPERIMENTAL | Induction with ivonescimab 20 mg/kg, carboplatin and etoposide every 21 days x 4 cycles followed by maintenance ivonescimab 20 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction. |
| Name | Type | Description |
|---|---|---|
| Ivonescimab 10 mg/kg | DRUG | Ivonescimab is a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) being investigated as a cancer immunotherapy agent. Ivonescimab binds to human VEGF-A which is involved in tumor angiogenesis, and to human PD-1 that is a cell surface receptor expressed primarily on activated T cells and acts to inhibit T cell activation. |
| Ligufalimab | DRUG | AK117 is a humanized IgG4 mAb being investigated as a cancer immunotherapy agent |
| Pembrolizumab (KEYTRUDA ®) | DRUG | Pembrolizumab is a humanized monoclonal antibody (IgG4 kappa isotype with stabilizing sequence alteration in the Fc region) against PD-1 (programmed cell death-1), produced in Chinese hamster ovary cells by recombinant DNA technology. |
| Ivonescimab 20 mg/kg | DRUG | Induction every 21 days x 4 cycles: Ivonescimab 20 mg/kg IV on Day 1 followed by carboplatin AUC 5 IV on Day 1 and etoposide 100 mg/m² IV on Day 1, 2 and 3 followed by maintenance ivonescimab 20 mg/kg every 21 days until progression, unacceptable toxicity or participant withdrawal. Up to 24 months of ivonescimab from cycle 1 day 1 of Induction. |
Inclusion Criteria: 1. Patient capable of voluntary giving her/his written informed consent. 2. Age ≥ 18 and \< 80 years old at the time of enrolment. 3. Eastern Cooperative Oncology Organization (ECOG) performance status score of 0 or 1. 4. Expected survival ≥ 6 months at randomization. 5. Patient...
Ivonescimab is an investigational oncology therapy being studied for multiple cancers, including biliary tract cancer, salivary gland cancer, pleural mesothelioma, non-small cell lung cancer, and metastatic colorectal cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA.
Ivonescimab is a monoclonal antibody (a -mab class drug) being developed as a small molecule therapy. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not detailed here.
Ivonescimab is being developed by Summit Therapeutics Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SMMT. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Ivonescimab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received FDA approval and is still being studied in clinical trials to determine its safety and effectiveness for treating cancer.
Ivonescimab is being studied in several clinical trials, including NCT06840834 for pleural mesothelioma, NCT07057791 for extensive-stage small cell lung cancer, NCT07264075 for head and neck cancer, and NCT07359456 for metastatic colorectal cancer. These trials are in various stages of recruitment.
Yes, Ivonescimab is also known as Ivonescimab Injection, Ivonescimab 10 mg/kg, and Ivonescimab/kg. These names refer to the same drug product being developed by Summit Therapeutics Inc. for the treatment of various cancers.