Claims for Patent: 12,599,606

Summary for Patent: 12,599,606

Title:	Therapies with 3rd generation EGFR tyrosine kinase inhibitors
Abstract:	The present invention relates to therapies with 3rd generation EGFR tyrosine kinase inhibitors. Embodiments of the invention relate to the administration of lazertinib to patients diagnosed with non-small cell lung cancer (NSCLC).
Inventor(s):	Seonmi Kang, SeWoong Oh
Assignee:	Yuhan Corp , Janssen Biotech Inc
Application Number:	US18/453,743
Patent Claims:	1. A method of treating cancer in a human subject comprising administering to the subject (i) lazertinib or a solvate, hydrate, tautomer, or a pharmaceutically acceptable salt thereof, in an amount of about 20 mg to about 320 mg once daily, and (ii) a therapeutically effective amount of an isolated bispecific anti-epidermal growth factor receptor (EGFR)/hepatocyte growth factor receptor (c-Met) antibody, wherein the cancer is advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR Exon 19 deletions or EGFR exon 21 L858R substitution mutations. 2. The method of claim 1, wherein the subject exhibits brain metastasis. 3. The method of claim 1, comprising administering the lazertinib to the subject in an amount of about 80 mg to about 240 mg once daily. 4. The method of claim 1 comprising administering the lazertinib to the subject in an amount of about 240 mg once daily. 5. The method of claim 1 comprising administering the lazertinib to the subject in an amount of about 160 mg once daily. 6. The method of claim 1 comprising administering the lazertinib to the subject in an amount of about 80 mg once daily. 7. The method of claim 1, wherein the bispecific anti-EGFR/c-Met antibody comprises a first domain that binds EGFR comprising a heavy chain complementarity determining region 1 (HCDR1) of SEQ ID NO: 1, a HCDR2 of SEQ ID NO: 2, a HCDR3 of SEQ ID NO: 3, a light chain complementarity determining region 1 (LCDR1) of SEQ ID NO: 4, a LCDR2 of SEQ ID NO: 5 and a LCDR3 of SEQ ID NO: 6 and a second domain that binds c-Met comprising a HCDR1 of SEQ ID NO: 7, a HCDR2 of SEQ ID NO: 8, a HCDR3 of SEQ ID NO: 9, a LCDR1 of SEQ ID NO: 10, a LCDR2 of SEQ ID NO: 11 and a LCDR3 of SEQ ID NO: 12. 8. The method of claim 1, wherein the first domain that binds EGFR comprises a heavy chain variable region (VH) of SEQ ID NO: 13 and a light chain variable region (VL) of SEQ ID NO: 14 and the second domain that binds c-Met comprises the VH of SEQ ID NO: 15 and the VL of SEQ ID NO: 16. 9. The method of claim 1, wherein the bispecific anti-EGFR/c-Met antibody is an IgG 1 isotype. 10. The method of claim 1, wherein the bispecific anti-EGFR/c-Met antibody comprises a first heavy chain (HC1) of SEQ ID NO: 17, a first light chain (LC1) of SEQ ID NO: 18, a second heavy chain (HC2) of SEQ ID NO: 19 and a second light chain (LC2) of SEQ ID NO: 20. 11. The method of claim 1, wherein the bispecific anti-EGFR/c-Met antibody has a biantennary glycan structure with a fucose content of between about 1% to about 15%. 12. The method of claim 1, wherein the lazertinib is a lazertinib mesylate hydrate.