# US 2026/0062484 A1 · Bispecific antigen-binding molecules and methods of use > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2026/0062484 A1 - Document ID: US20260062484A1 - Status: Published application - Kind: A1 - Application number: 19/176,544 - Filed: 2025-04-11 - Published: 2026-03-05 - Earliest claimed: 2018-02-08 - Assignees: Genentech, Inc. - Applicants: Genentech, Inc. - Inventors: Diego ELLERMAN; Teemu T. Junttila; Twyla Noelle Lombana; Dionysos Slaga; Christoph Spiess - Web page: https://patentgrep.com/patent/US20260062484A1 ## CPC - C07K 16/2809: {against the T-cell receptor (TcR)-CD3 complex} - A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)} - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61K 47/65: Peptidic linkers, binders or spacers, e.g. peptidic enzyme-labile linkers - A61P 35/00: Antineoplastic agents - A61P 35/02: specific for leukemia - C07K 16/1145: {Env proteins, e.g. gp41, gp110/120, gp160, V3, principal neutralising domain [PND] or CD4-binding site} - C07K 16/2803: {against the immunoglobulin superfamily} - C07K 16/2818: {against CD28 or CD152} - C07K 16/32: against translation products of oncogenes - C07K 16/468: {Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies} - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## Abstract The present invention provides bispecific antigen-binding molecules having a monovalent arm specific to a first target antigen (e.g., a T cell antigen, such as CD3) and a bivalent arm specific for a second target antigen (e.g., a tumor antigen, such as HER2). Bispecific antigen-binding molecules are useful in the treatment of disorders, such as cancer (e.g., HER2-positive cancer). The invention also features methods of producing bispecific antigen-binding molecules, methods of treating disorders using bispecific antigen-binding molecules, and compositions including bispecific antigen-binding molecules. ## Claims ### Claim at position 1 1-237. (canceled) ### Claim 238 A method of: (a) treating or delaying the progression of a HER2-positive cancer in a subject in need thereof; or (b) enhancing immune function in a subject having a HER2-positive cancer, wherein the method comprises administering to the subject a bispecific antigen-binding molecule that specifically binds CD3 and HER2 comprising a monovalent arm and a bivalent arm, wherein: (a) the monovalent arm comprises a FabA that specifically binds CD3, wherein the C-terminus of the FabA is fused to an N-terminus of a first Fc subunit, and wherein the FabA comprises the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 1, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 2, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 3, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 4, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 5, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 6; (b) the bivalent arm comprises a FabB1 and a FabB2 that each specifically binds HER2, wherein the C-terminus of the FabB2 is fused to the N-terminus of the FabB1, and the C-terminus of the FabB1 is fused to an N-terminus of a second Fc subunit, wherein the FabB1 and the FabB2 each comprise the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 11, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 36, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 37, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 38, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 29, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 26; and (c) the first Fc subunit is associated with the second Fc subunit to form an Fc domain. ### Claim 239 (depends on 238) The method of claim 238, wherein: (a) the FabA comprises a VHA region and a VLA region, wherein the VHA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 7, and the VLA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 8; (b) the FabB1 comprises a VHB1 region and a VLB1 region, wherein the VHB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 41, and the VLB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 49; and (c) the FabB2 comprises a VHB2 region and a VLB2 region, wherein the VHB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 41, and the VLB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 49. ### Claim 240 (depends on 239) The method of claim 239, wherein: (a) the VHA region comprises the amino acid sequence of SEQ ID NO: 7, and the VLA region comprises the amino acid sequence of SEQ ID NO: 8; (b) the VHB1 region comprises the amino acid sequence of SEQ ID NO: 41, and the VLB1 region comprises the amino acid sequence of SEQ ID NO: 49; and (c) the VHB2 region comprises the amino acid sequence of SEQ ID NO: 41, and the VLB2 region comprises the amino acid sequence of SEQ ID NO: 49. ### Claim 241 (depends on 238) The method of claim 238, wherein the HER2-positive cancer is: (a) characterized by tumor cells that express HER2 at an average copy number of 200,000 or more copies per cell; and/or (b) a breast cancer, a gastric cancer, a colorectal cancer, a non-small cell lung cancer, a renal cancer, a bladder cancer, a pancreatic cancer, a prostate cancer, a liver cancer, a head and neck cancer, a melanoma, an ovarian cancer, a mesothelioma, a glioblastoma, an endometrial cancer, or an osteosarcoma. ### Claim 242 (depends on 238) The method of claim 238, wherein the bispecific antigen-binding molecule is administered to the subject: (a) in a dosage of about 0.01 mg/kg to about 10 mg/kg, of about 0.1 mg/kg to about 10 mg/kg, or of about 1 mg/kg; (b) subcutaneously, intravenously, intramuscularly, topically, orally, transdermally, intraperitoneally, intraorbitally, by implantation, by inhalation, intrathecally, intraventricularly, or intranasally; and/or (c) in combination with a PD-1 axis binding antagonist and/or an additional therapeutic agent. ### Claim 243 (depends on 242) The method of claim 242, wherein: (a) the PD-1 axis binding antagonist or additional therapeutic agent is to be administered concurrently with, prior to, or subsequent to the administration of the medicament; and/or (b) the PD-1 axis binding antagonist is selected from the group consisting of a PD-L1 binding antagonist, a PD-1 binding antagonist, and a PD-L2 binding antagonist. ### Claim 244 (depends on 243) The method of claim 243, wherein the PD-1 axis binding antagonist is: (i) a PD-1 binding antagonist selected from the group consisting of MDX-1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 (spartalizumab), REGN2810 (cemiplimab), and BGB-108; (ii) a PD-L1 binding antagonist selected from the group consisting of MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab), and MSB0010718C (avelumab); or (iii) a PD-L2 binding antagonist, wherein the PD-L2 binding antagonist is an antibody or an immunoadhesin. ### Claim 245 A method of: (a) treating or delaying the progression of a HER2-positive cancer in a subject in need thereof; or (b) enhancing immune function in a subject having a HER2-positive cancer, wherein the method comprises administering to the subject a bispecific antigen-binding molecule that specifically binds CD3 and HER2 comprising a monovalent arm and a bivalent arm, wherein: (a) the monovalent arm comprises a FabA that specifically binds CD3, wherein the C-terminus of the FabA is fused to an N-terminus of a first Fc subunit, and wherein the FabA comprises the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 1, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 2, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 3, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 4, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 5, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 6; (b) the bivalent arm comprises a FabB1 and a FabB2 that each specifically binds HER2, wherein the C-terminus of the FabB2 is fused to the N-terminus of the FabB1, and the C-terminus of the FabB1 is fused to an N-terminus of a second Fc subunit, wherein the FabB1 and the FabB2 each comprise the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 11, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 19, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 20, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 21, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 22, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 26; and (c) the first Fc subunit is associated with the second Fc subunit to form an Fc domain. ### Claim 246 (depends on 245) The method of claim 245, wherein: (a) the FabA comprises a VHA region and a VLA region, wherein the VHA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 7, and the VLA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 8; (b) the FabB1 comprises a VHB1 region and a VLB1 region, wherein the VHB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 24, and the VLB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 27; and (c) the FabB2 comprises a VHB2 region and a VLB2 region, wherein the VHB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 24, and the VLB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 27. ### Claim 247 (depends on 246) The method of claim 246, wherein: (a) the VHA region comprises the amino acid sequence of SEQ ID NO: 7, and the VLA region comprises the amino acid sequence of SEQ ID NO: 8; (b) the VHB1 region comprises the amino acid sequence of SEQ ID NO: 24, and the VLB1 region comprises the amino acid sequence of SEQ ID NO: 27; and (c) the VHB2 region comprises the amino acid sequence of SEQ ID NO: 24, and the VLB2 region comprises the amino acid sequence of SEQ ID NO: 27. ### Claim 248 (depends on 245) The method of claim 245, wherein the HER2-positive cancer is: (a) characterized by tumor cells that express HER2 at an average copy number of 200,000 or more copies per cell; and/or (b) a breast cancer, a gastric cancer, a colorectal cancer, a non-small cell lung cancer, a renal cancer, a bladder cancer, a pancreatic cancer, a prostate cancer, a liver cancer, a head and neck cancer, a melanoma, an ovarian cancer, a mesothelioma, a glioblastoma, an endometrial cancer, or an osteosarcoma. ### Claim 249 (depends on 245) The method of claim 245, wherein the bispecific antigen-binding molecule is administered to the subject: (a) in a dosage of about 0.01 mg/kg to about 10 mg/kg, of about 0.1 mg/kg to about 10 mg/kg, or of about 1 mg/kg; (b) subcutaneously, intravenously, intramuscularly, topically, orally, transdermally, intraperitoneally, intraorbitally, by implantation, by inhalation, intrathecally, intraventricularly, or intranasally; and/or (c) in combination with a PD-1 axis binding antagonist and/or an additional therapeutic agent. ### Claim 250 (depends on 249) The method of claim 249, wherein: (a) the PD-1 axis binding antagonist or additional therapeutic agent is to be administered concurrently with, prior to, or subsequent to the administration of the medicament; and/or (b) the PD-1 axis binding antagonist is selected from the group consisting of a PD-L1 binding antagonist, a PD-1 binding antagonist, and a PD-L2 binding antagonist. ### Claim 251 (depends on 250) The method of claim 250, wherein the PD-1 axis binding antagonist is: (i) a PD-1 binding antagonist selected from the group consisting of MDX-1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 (spartalizumab), REGN2810 (cemiplimab), and BGB-108; (ii) a PD-L1 binding antagonist selected from the group consisting of MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab), and MSB0010718C (avelumab); or (iii) a PD-L2 binding antagonist, wherein the PD-L2 binding antagonist is an antibody or an immunoadhesin. ### Claim 252 A method of: (a) treating or delaying the progression of a HER2-positive cancer in a subject in need thereof; or (b) enhancing immune function in a subject having a HER2-positive cancer, wherein the method comprises administering to the subject a bispecific antigen-binding molecule that specifically binds CD3 and HER2 comprising a monovalent arm and a bivalent arm, wherein: (a) the monovalent arm comprises a FabA that specifically binds CD3, wherein the C-terminus of the FabA is fused to an N-terminus of a first Fc subunit, and wherein the FabA comprises the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 1, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 2, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 3, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 4, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 5, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 6; (b) the bivalent arm comprises a FabB1 and a FabB2 that each specifically binds HER2, wherein the C-terminus of the FabB2 is fused to the N-terminus of the FabB1, and the C-terminus of the FabB1 is fused to an N-terminus of a second Fc subunit, wherein the FabB1 and the FabB2 each comprise the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 11, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 19, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 32, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 21, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 22, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 23; and (c) the first Fc subunit is associated with the second Fc subunit to form an Fc domain. ### Claim 253 (depends on 252) The method of claim 252, wherein: (a) the FabA comprises a VHA region and a VLA region, wherein the VHA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 7, and the VLA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 8; (b) the FabB1 comprises a VHB1 region and a VLB1 region, wherein the VHB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 33, and the VLB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 25; and (c) the FabB2 comprises a VHB2 region and a VLB2 region, wherein the VHB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 33, and the VLB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 25. ### Claim 254 (depends on 253) The method of claim 253, wherein: (a) the VHA region comprises the amino acid sequence of SEQ ID NO: 7, and the VLA region comprises the amino acid sequence of SEQ ID NO: 8; (b) the VHB1 region comprises the amino acid sequence of SEQ ID NO: 33, and the VLB1 region comprises the amino acid sequence of SEQ ID NO: 25; and (c) the VHB2 region comprises the amino acid sequence of SEQ ID NO: 33, and the VLB2 region comprises the amino acid sequence of SEQ ID NO: 25. ### Claim 255 (depends on 252) The method of claim 252, wherein the HER2-positive cancer is: (a) characterized by tumor cells that express HER2 at an average copy number of 200,000 or more copies per cell; and/or (b) a breast cancer, a gastric cancer, a colorectal cancer, a non-small cell lung cancer, a renal cancer, a bladder cancer, a pancreatic cancer, a prostate cancer, a liver cancer, a head and neck cancer, a melanoma, an ovarian cancer, a mesothelioma, a glioblastoma, an endometrial cancer, or an osteosarcoma. ### Claim 256 (depends on 252) The method of claim 252, wherein the bispecific antigen-binding molecule is administered to the subject: (a) in a dosage of about 0.01 mg/kg to about 10 mg/kg, of about 0.1 mg/kg to about 10 mg/kg, or of about 1 mg/kg; (b) subcutaneously, intravenously, intramuscularly, topically, orally, transdermally, intraperitoneally, intraorbitally, by implantation, by inhalation, intrathecally, intraventricularly, or intranasally; and/or (c) in combination with a PD-1 axis binding antagonist and/or an additional therapeutic agent. ### Claim 257 (depends on 256) The method of claim 256, wherein: (a) the PD-1 axis binding antagonist or additional therapeutic agent is to be administered concurrently with, prior to, or subsequent to the administration of the medicament; and/or (b) the PD-1 axis binding antagonist is selected from the group consisting of a PD-L1 binding antagonist, a PD-1 binding antagonist, and a PD-L2 binding antagonist. ### Claim 258 (depends on 257) The method of claim 257, wherein the PD-1 axis binding antagonist is: (i) a PD-1 binding antagonist selected from the group consisting of MDX-1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 (spartalizumab), REGN2810 (cemiplimab), and BGB-108; (ii) a PD-L1 binding antagonist selected from the group consisting of MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab), and MSB0010718C (avelumab); or (iii) a PD-L2 binding antagonist, wherein the PD-L2 binding antagonist is an antibody or an immunoadhesin. ### Claim 259 A method of: (a) treating or delaying the progression of a HER2-positive cancer in a subject in need thereof; or (b) enhancing immune function in a subject having a HER2-positive cancer, wherein the method comprises administering to the subject a bispecific antigen-binding molecule that specifically binds CD3 and HER2 comprising a monovalent arm and a bivalent arm, wherein: (a) the monovalent arm comprises a FabA that specifically binds CD3, wherein the C-terminus of the FabA is fused to an N-terminus of a first Fc subunit, and wherein the FabA comprises the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 1, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 2, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 3, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 4, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 5, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 6; (b) the bivalent arm comprises a FabB1 and a FabB2 that each specifically binds HER2, wherein the C-terminus of the FabB2 is fused to the N-terminus of the FabB1, and the C-terminus of the FabB1 is fused to an N-terminus of a second Fc subunit, wherein the FabB1 and the FabB2 each comprise the following HVRs: (i) an HVR-H1 comprising the amino acid sequence of SEQ ID NO: 11, (ii) an HVR-H2 comprising the amino acid sequence of SEQ ID NO: 36, (iii) an HVR-H3 comprising the amino acid sequence of SEQ ID NO: 43, (iv) an HVR-L1 comprising the amino acid sequence of SEQ ID NO: 21, (v) an HVR-L2 comprising the amino acid sequence of SEQ ID NO: 29, and (vi) an HVR-L3 comprising the amino acid sequence of SEQ ID NO: 26; and (c) the first Fc subunit is associated with the second Fc subunit to form an Fc domain. ### Claim 260 (depends on 259) The method of claim 259, wherein: (a) the FabA comprises a VHA region and a VLA region, wherein the VHA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 7, and the VLA region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 8; (b) the FabB1 comprises a VHB1 region and a VLB1 region, wherein the VHB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 44, and the VLB1 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 48; and (c) the FabB2 comprises a VHB2 region and a VLB2 region, wherein the VHB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 44, and the VLB2 region comprises an amino acid sequence having at least 95% sequence identity to SEQ ID NO: 48. ### Claim 261 (depends on 260) The method of claim 260, wherein: (a) the VHA region comprises the amino acid sequence of SEQ ID NO: 7, and the VLA region comprises the amino acid sequence of SEQ ID NO: 8; (b) the VHB1 region comprises the amino acid sequence of SEQ ID NO: 44, and the VLB1 region comprises the amino acid sequence of SEQ ID NO: 48; and (c) the VHB2 region comprises the amino acid sequence of SEQ ID NO: 44, and the VLB2 region comprises the amino acid sequence of SEQ ID NO: 48. ### Claim 262 (depends on 259) The method of claim 259, wherein the HER2-positive cancer is: (a) characterized by tumor cells that express HER2 at an average copy number of 200,000 or more copies per cell; and/or (b) a breast cancer, a gastric cancer, a colorectal cancer, a non-small cell lung cancer, a renal cancer, a bladder cancer, a pancreatic cancer, a prostate cancer, a liver cancer, a head and neck cancer, a melanoma, an ovarian cancer, a mesothelioma, a glioblastoma, an endometrial cancer, or an osteosarcoma. ### Claim 263 (depends on 259) The method of claim 259, wherein the bispecific antigen-binding molecule is administered to the subject: (a) in a dosage of about 0.01 mg/kg to about 10 mg/kg, of about 0.1 mg/kg to about 10 mg/kg, or of about 1 mg/kg; (b) subcutaneously, intravenously, intramuscularly, topically, orally, transdermally, intraperitoneally, intraorbitally, by implantation, by inhalation, intrathecally, intraventricularly, or intranasally; and/or (c) in combination with a PD-1 axis binding antagonist and/or an additional therapeutic agent. ### Claim 264 (depends on 263) The method of claim 263, wherein: (a) the PD-1 axis binding antagonist or additional therapeutic agent is to be administered concurrently with, prior to, or subsequent to the administration of the medicament; and/or (b) the PD-1 axis binding antagonist is selected from the group consisting of a PD-L1 binding antagonist, a PD-1 binding antagonist, and a PD-L2 binding antagonist. ### Claim 265 (depends on 264) The method of claim 264, wherein the PD-1 axis binding antagonist is: (i) a PD-1 binding antagonist selected from the group consisting of MDX-1106 (nivolumab), MK-3475 (pembrolizumab), MEDI-0680 (AMP-514), PDR001 (spartalizumab), REGN2810 (cemiplimab), and BGB-108; (ii) a PD-L1 binding antagonist selected from the group consisting of MPDL3280A (atezolizumab), MDX-1105, MEDI4736 (durvalumab), and MSB0010718C (avelumab); or (iii) a PD-L2 binding antagonist, wherein the PD-L2 binding antagonist is an antibody or an immunoadhesin.