# US 2013/0280243 A1 · COMBINATION THERAPY OF AN AFUCOSYLATED CD20 ANTIBODY WITH A mTOR INHIBITOR > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0280243 A1 - Document ID: US20130280243A1 - Status: Published application - Kind: A1 - Application number: 13/660,889 - Filed: 2012-10-25 - Published: 2013-10-24 - Earliest claimed: 2010-04-27 - Assignees: Roche Glycart AG - Applicants: Roche Glycart AG - Inventors: FRANK HERTING; CHRISTIAN KLEIN - Web page: https://patentgrep.com/patent/US20130280243A1 ## CPC - A61K 39/3955: {against proteinaceous materials, e.g. enzymes, hormones, lymphokines} - A61K 31/436: the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin - A61K 39/39558: {against tumor tissues, cells, antigens} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61N 5/10: X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy (A61N5/01 takes precedence) - A61P 35/00: Antineoplastic agents - A61P 35/02: specific for leukemia - A61P 35/04: specific for metastasis - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C07K 14/70596: {Molecules with a "CD"-designation not provided for elsewhere} - C07K 16/2887: {against CD20} - A61K 2039/505: {comprising antibodies} - C07K 2317/24: containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered - C07K 2317/40: characterized by post-translational modification - C07K 2317/41: Glycosylation, sialylation, or fucosylation - 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) - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - 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) ## Abstract The present invention is directed to the combination therapy of an afucosylated anti-CD20 antibody with a mTOR inhibitor for the treatment of cancer, especially to the combination therapy of CD20 expressing cancers with an afucosylated humanized B-Ly1 antibody and a mTOR inhibitor such as Temsirolimus or Everolimus. ## Claims ### Claim 1 A method of treatment of a patient suffering from cancer by administering an afucosylated anti-CD20 antibody with an amount of fucose of 60% or less, in combination with a mTOR inhibitor. ### Claim 2 (depends on 1) The method according to claim 1, wherein the amount of fucose is between 40% and 60%. ### Claim 3 (depends on 1) The method according to claim 1, wherein the amount of fucose of is 50% or less. ### Claim 4 (depends on 3) The method according to any one of claim 3, wherein said cancer is a CD20 expressing cancer. ### Claim 5 (depends on 4) The method according to claim 4, wherein said CD20 expressing cancer is a B-Cell Non-Hodgkin's lymphoma (NHL). ### Claim 6 (depends on 1, 2, 3, 4, 5) The method according to any one of claims 1 to 5, wherein said afucosylated anti-CD20 antibody is a type II anti-CD20 antibody. ### Claim 7 (depends on 6) The method according to claim 6, wherein said antibody is a humanized B-Ly1 antibody. ### Claim 8 (depends on 7) The method according to claim 7, wherein said mTOR inhibitor is rapamycin, or a rapamycin analog or derivative. ### Claim 9 (depends on 7) The method according to claim 7, wherein said mTOR inhibitor is Temsirolimus or Everolimus. ### Claim 10 (depends on 7) The method according to claim 7, wherein one or more additional other cytotoxic, chemotherapeutic or anti-cancer agents, or compounds or ionizing radiation that enhance the effects of such agents are administered. ### Claim 11 A composition comprising an afucosylated anti-CD20 antibody with an amount of fucose of 60% or less and a mTOR inhibitor for the treatment of cancer. ### Claim 12 (depends on 11) The composition according to claim 11, wherein said anti-afucosylated CD20 antibody is a humanized B-Ly1 antibody. ### Claim 13 A method of treatment of a patient suffering from cancer by administering an afucosylated anti-CD20 antibody with an amount of fucose of 60% or less in combination with a mTOR inhibitor, to a patient in the need of such treatment. ### Claim 14 (depends on 13) The method of treatment according to claim 13, wherein the amount of fucose of is between 40% and 60%. ### Claim 15 (depends on 13, 14) The method of treatment according to claims 13 to 14, wherein said cancer is a B-Cell Non-Hodgkin's lymphoma (NHL). ### Claim 16 (depends on 1, 2, 3, 4) The method according to claim 1-4, wherein the cancer is a lymphoma or a lymphocytic leukemia.