Methods for treating patients with locally advanced or metastatic urothelial cancer with antibody drug conjugates (adc) that bind 191p4d12 proteins in combination with pembrolizumab

A method of treating cancer in a human subject, comprising administering to the subject:

• (a) an effective amount of an antibody drug conjugate (ADC) comprising an anti-191P4D12 antibody or antigen binding fragment thereof and
• (b) an effective amount of an anti-PD-1 antibody;
• wherein the anti-191P4D12 antibody or antigen binding fragment thereof binds to 191P4D12 and is conjugated to one or more units of monomethyl auristatin E (MMAE);
• wherein the anti-PD-1 antibody comprises:
• (i) a light chain variable region comprising light chain CDR1, CDR2 and CDR3 of SEQ ID NOs:
• 24, 25 and 26, respectively and (ii) a heavy chain variable region comprising heavy chain CDR1, CDR2 and CDR3 of SEQ ID NOs:
• 29, 30 and 31, respectively;
• wherein the anti-191P4D12 antibody or antigen binding fragment thereof comprises a heavy chain variable region comprising complementarity determining regions (CDRs) comprising the amino acid sequences of the CDRs of the heavy chain variable region set forth in SEQ ID NO:22 and a light chain variable region comprising CDRs comprising the amino acid sequences of the CDRs of the light chain variable region set forth in SEQ ID NO:23;
• wherein the subject has urothelial or bladder cancer;
• wherein the subject has not received an immune checkpoint inhibitor (CPI) therapy;
• and
• wherein the subject is ineligible to receive cisplatin treatment (cisplatin ineligible).