Dosing regimens for targeted tgf-b inhibition for use in treating cancer in treatment naïve subjects
AssigneeMerck Patent GmbH
InventorsLaureen Ojalvo, Samer El Bawab, Isabelle Dussault, Yulia Vugmeyster, Akash Khandelwal, Olaf Christensen
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Abstract
This disclosure relates to dosage regimens for targeted TGF-β inhibition with a bi-functional fusion protein for use in a method of treating cancer or inhibiting tumor growth in treatment naïve patients.
Claims57
A method of treating advanced non-small cell lung cancer (NSCLC) or inhibiting tumor growth in a treatment naïve patient in need thereof, the method comprising administering to the patient a dose of at least 500 mg of a protein comprising a first polypeptide and a second polypeptide,
- wherein the first polypeptide comprises:
- (a) at least a variable region of a heavy chain of an antibody that binds to human protein Programmed Death Ligand 1 (PD-L1);
- and (b) human Transforming Growth Factor β Receptor II (TGFβRII), or a fragment thereof, capable of binding Transforming Growth Factor β (TGFβ),
- wherein the second polypeptide comprises at least a variable region of a light chain of an antibody that binds PD-L1, and
- wherein the heavy chain of the first polypeptide and the light chain of the second polypeptide, when combined, form an antigen binding site that binds PD-L1.
An intravenous drug delivery formulation for use in a method of treating advanced non-small cell lung cancer (NSCLC) or inhibiting tumor growth in a treatment naïve cancer patient in need thereof, the formulation comprising 500 mg-3000 mg of a protein comprising a first polypeptide and a second polypeptide;
- wherein the first polypeptide comprises:
- (a) at least a variable region of a heavy chain of an antibody that binds to human protein Programmed Death Ligand 1 (PD-L1);
- and (b) human Transforming Growth Factor β Receptor II (TGFβRII), or a fragment thereof, capable of binding Transforming Growth Factor β (TGFβ),
- wherein the second polypeptide comprises at least a variable region of a light chain of an antibody that binds PD-L1, and
- wherein the heavy chain of the first polypeptide and the light chain of the second polypeptide, when combined, form an antigen binding site that binds PD-L1.
A drug delivery device for use in a method of treating advanced non-small cell lung cancer (NSCLC) or inhibiting tumor growth in a treatment naïve cancer patient in need thereof, the device comprising a formulation comprising 500 mg-3000 mg of a protein comprising a first polypeptide and a second polypeptide;
- wherein the first polypeptide comprises:
- (a) at least a variable region of a heavy chain of an antibody that binds to human protein Programmed Death Ligand 1 (PD-L1);
- and (b) human Transforming Growth Factor β Receptor II (TGFβRII), or a fragment thereof, capable of binding Transforming Growth Factor β (TGFβ),
- wherein the second polypeptide comprises at least a variable region of a light chain of an antibody that binds PD-L1, and
- wherein the heavy chain of the first polypeptide and the light chain of the second polypeptide, when combined, form an antigen binding site that binds PD-L1.
An anti-PD-L1/TGFβ Trap protein comprising a first polypeptide and a second polypeptide for use in a method of treating advanced non-small cell lung cancer (NSCLC) or inhibiting tumor growth in a treatment naïve cancer patient in need thereof, the method comprising administering 500 mg-3000 mg of the protein to the patient;
- wherein the first polypeptide comprises:
- (a) at least a variable region of a heavy chain of an antibody that binds to human protein Programmed Death Ligand 1 (PD-L1);
- and (b) human Transforming Growth Factor β Receptor II (TGFβRII), or a fragment thereof, capable of binding Transforming Growth Factor β (TGFβ),
- wherein the second polypeptide comprises at least a variable region of a light chain of an antibody that binds PD-L1, and
- wherein the heavy chain of the first polypeptide and the light chain of the second polypeptide, when combined, form an antigen binding site that binds PD-L1.
Dependencies are inferred from the claim text.