IP Library › Granted Patent US 12,599,606
Granted Patent B2
US 12,599,606 · App. 18/453,743 · Granted Apr 14, 2026

Therapies with 3rd generation EGFR tyrosine kinase inhibitors

Inventors: Seonmi Kang (Seoul, KR); Sewoong Oh (Suwon-si, KR)
Assignees: Janssen Biotech, Inc.; Yuhan Corporation
A61K31/5377A61P35/00A61P35/04
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Quick Facts
Patent No.
US 12,599,606
App. No.
18/453,743
Granted
Apr 14, 2026
Kind
B2
Abstract

The present invention relates to therapies with 3 rd 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).

Claims (13)

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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 20, 2024
From: KANG, SEONMI; OH, SEWOONG
To: YUHAN CORPORATION
Reel/Frame 066836/0279 →
Continuity (3)
Continuation 15931626 · May 14, 2020
Provisional Application 62847563 · May 14, 2019
Related Publication 20240180917A1 · Jun 6, 2024
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