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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