Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN2810 · 4 trials · 7 indications
OS was defined as the time from randomization to the date of death due to any cause.
OS was defined as the time from randomization to the date of death due to any cause.
The percentage of subject achieving undetectable PSA levels at 6 months after the combination will use measured to determine safety and activity of combined hormonal chemoimmunotherapy.
| Arm | Type | Description |
|---|---|---|
| Chemo | OTHER | Part 1: Chemotherapy |
| REGN2810+Chemo Part 1 | EXPERIMENTAL | Part 1: REGN2810+chemo |
| REGN2810+AbbrevChemo+ipi | EXPERIMENTAL | Part 1: REGN2810+abbrev chemo+ipi |
| Placebo+Chemo | EXPERIMENTAL | Part 2: Placebo plus chemo |
| REGN2810+Chemo Part 2 | EXPERIMENTAL | Part 2: REGN2810+chemo |
| ADT Followed by Chemoimmunotherapy | EXPERIMENTAL | REGN2810 followed by chemoimmunotherapy: Initiate degarelix 240mg SC once, followed by leuprolide acetate 22.5mg SC every 3 months. Week 4 start cemiplimab (REGN 2810) 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease. Week 10 start docetaxel 75 mg/m2 every 21 days for up to 6 cycles. |
| REGN2810 | EXPERIMENTAL | REGN2810 administered IV over a 30 minute infusion |
| Name | Type | Description |
|---|---|---|
| REGN2810 | DRUG | REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2 |
| REGN2810/chemo/ipi | DRUG | REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1 |
| Chemotherapy | OTHER | Platinum-based doublet chemotherapy Part 1 |
| Placebo | DRUG | Matching placebo Part 2 |
| Degarelix | DRUG | Degarelix is administered subcutaneously (SC) at a dose of 240mg once. |
| Leuprolide Acetate | DRUG | Leuprolide acetate is provided at a dose of 22.5mg SC every 3 months. |
| Docetaxel | DRUG | Docetaxel is administered starting at week 10 at a dose of 75 mg/m2 every 21 days for up to 6 cycles. |
Key Inclusion Criteria: 1. Men and women ≥20 years of age for Japanese patients 2. Patients with histologically or cytologically documented squamous or non-squamous NSCLC with stage IIIB or IIIC disease who are not candidates for treatment with definitive concurrent chemoradiation or patients with ...
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REGN2810 is an investigational anti-PD-1 antibody being studied in oncology indications including non-small cell lung cancer, metastatic prostate cancer, recurrent squamous cell carcinoma of the head and neck, and melanoma. It is in clinical development and has not been approved by the FDA.
REGN2810 targets PD-1, a protein involved in immune checkpoint regulation. By binding to PD-1, it is designed to modulate the immune system's anti-tumor response. It is being evaluated across multiple cancer types in clinical trials.
REGN2810 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
REGN2810 is in clinical development across multiple phases. Trials include a Phase 1 study in melanoma, a Phase 1 study in head and neck cancer, a Phase 2 study in metastatic prostate cancer, and a Phase 3 study in non-small cell lung cancer. It remains investigational.
REGN2810 has been studied in several trials, including NCT03002376 in melanoma, NCT03198130 in head and neck cancer, NCT03409614 in non-small cell lung cancer, and NCT03951831 in metastatic prostate cancer. These trials are at various stages of completion.
Yes, REGN2810 is also known as cemiplimab. In clinical trials, it is sometimes referred to as cemiplimab (anti-PD-1 antibody). The drug is being investigated for multiple cancer indications under this name.