Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pembrolizumab/Quavonlimab · 1 trial · 1 indication
DLTs = ≥1 of the following treatment-related toxicities: Grade (G)4 nonhematologic toxicity; G4 hematologic toxicity lasting \>7 days OR G4 platelet count decreased OR G3 platelet count decreased if associated with bleeding; G3 nonhematologic toxicity including G3 fatigue (lasting \>3 days), G3 diarrhea, nausea, vomiting lasting ≥72 hours, G3 rash ≥7 days despite treatment, G3 uncontrolled hypertension; G3/4 nonhematologic laboratory abnormality if requires medical intervention, hospitalization, or persists for \>1 week; G 3/4 febrile neutropenia, alanine aminotransferase, aspartate aminotransferase and/or bilirubin increase; drug-induced liver injury meeting the Hy's law; G4 creatinine increase; G4 electrolyte abnormalities; treatment related adverse event causing study intervention discontinuation during the first 21 days or administration delay \>14 days during the first 21 days; G5 toxicity. The number of participants with ≥1 DLTs in the safety lead-in phase will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience at least one AE will be presented.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 that has been modified for this study to include a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
| Arm | Type | Description |
|---|---|---|
| Coformulation Pembrolizumab/Quavonlimab | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| Coformulation Pembrolizumab/Quavonlimab + Lenvatinib | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS lenvatinib 20 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. Lenvatinib will be administered orally once-daily (QD) until progressive disease or discontinuation. |
| Coformulation Pembrolizumab/Quavonlimab + MK-4830 | EXPERIMENTAL | Participants receive pembrolizumab/quavonlimab (coformulation of pembrolizumab 400 mg and quavonlimab 25 mg) PLUS MK-4830 800 mg. Pembrolizumab/quavonlimab will be administered by intravenous (IV) infusion once every 6 weeks (Q6W) for up to 18 infusions (up to approximately 2 years) or until progressive disease or discontinuation. MK-4830 will be administered by IV infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| Coformulation Favezelimab/Pembrolizumab | EXPERIMENTAL | Participants receive favezelimab/pembrolizumab (coformulation of favezelimab 800 mg and pembrolizumab 200 mg) administered by intravenous (IV) infusion once every 3 weeks (Q3W) for up to 36 infusions (up to approximately 2 years) or until progressive disease or discontinuation. |
| R-DXd | EXPERIMENTAL | Participants receive 5.6 mg/kg R-DXd via IV infusion every three weeks (Q3W) until progressive disease or discontinuation. |
| Name | Type | Description |
|---|---|---|
| coformulation pembrolizumab/quavonlimab | BIOLOGICAL | Intravenous (IV) infusion |
| lenvatinib | DRUG | Oral administration |
| MK-4830 | BIOLOGICAL | IV infusion |
| coformulation favezelimab/pembrolizumab | BIOLOGICAL | IV infusion |
| R-DXd | BIOLOGICAL | IV Infusion |
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Arms A-E: * Has histologically or cytologically confirmed diagnosis of ES-SCLC in need of second-line therapy * Has progressed on or after treatment with an anti-programmed cell death 1 (PD-1)/ pro...
Pembrolizumab/quavonlimab is an investigational coformulation of two monoclonal antibodies, pembrolizumab and quavonlimab, being developed by Merck & Company, Inc. (MRK). It is a fixed-dose combination given as a single therapy and is in Phase 1 clinical development for small cell lung carcinoma. It is not approved for any indication.
Pembrolizumab/quavonlimab is being studied for extensive-stage small cell lung carcinoma in patients who need second-line therapy. The Phase 1 trial evaluates the coformulation as monotherapy or in combination with pembrolizumab. It is investigational and has not been approved for this or any other use.
Pembrolizumab/quavonlimab targets PDCD1, also known as PD-1. Both antibodies in the coformulation are PDCD1 inhibitors. Pembrolizumab is a PD-1 inhibitor, and quavonlimab is also a PD-1 inhibitor, so the combination delivers two antibodies directed at the same checkpoint target.
Pembrolizumab/quavonlimab is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical program for the coformulation, including the Phase 1 KEYNOTE-B98 trial in extensive-stage small cell lung carcinoma.
Pembrolizumab/quavonlimab is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. The program consists of one active trial, and no trials have been completed.
Pembrolizumab/quavonlimab is being studied in NCT04938817, titled MK-3475-B98/KEYNOTE-B98. This Phase 1 trial is active but not recruiting, has an enrollment of 110 participants, and is randomized and controlled. It is being conducted in the United States, Australia, Austria, Canada, Hungary, Israel, Italy, Poland, Russia, South Korea, Spain, and Switzerland.