Dosing for treatment with anti-cd20/anti-cd3 bispecific antibodies in elderly patients
AssigneesGenentech, Inc., Hoffmann-La Roche Inc.
InventorsHuang HUANG, Carol Elaine O'HEAR, Iris Tranthuyngan TO, Michael Ching-sun WEI, Shen YIN
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Abstract
The present invention relates to the treatment of elderly subjects (e.g., subjects aged 65 years or older) having relapsed and/or refractory (R/R) non-Hodgkin's lymphoma (NHL). More specifically, the invention pertains to the treatment of subjects having an R/R NHL by intravenous administration of mosunetuzumab.
Claims26
A method of treating a subject aged about 65 years or older having a relapsed or refractory (R/R) non-Hodgkin's lymphoma (NHL) comprising intravenously administering to the subject mosunetuzumab in a dosing regimen comprising at least a first dosing cycle, a second dosing cycle, and a third dosing cycle, wherein:
- (a) the first three-dose dosing cycle comprises a first dose (C1D1), a second dose (C1D2), and a third dose (C1D3) of mosunetuzumab, wherein the C1 D1 is about 1 mg, the C1 D2 is about 2 mg, and the C1 D3 is about 60 mg;
- (b) the second dosing cycle comprises a single dose (C2D1) of mosunetuzumab, wherein the C2D1 is about 60 mg;
- and
- (c) the third dosing cycle comprises a single dose (C3D1) of mosunetuzumab, wherein the C3D1 is about 30 mg.
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A method of treating a population of subjects aged about 65 years or older having an R/R NHL comprising intravenously administering to each subject mosunetuzumab in a dosing regimen comprising eight 21-day dosing cycles, wherein:
- (a) the first three-dose dosing cycle comprises a first dose (C1D1), a second dose (C1D2), and a third dose (C1D3) of mosunetuzumab administered on Days 1, 8, and 15, respectively, of the first dosing cycle, wherein the C1 D1 is about 1 mg, the C1 D2 is about 2 mg, and the C1 D3 is about 60 mg;
- (b) the second dosing cycle comprises a single dose (C2D1) of mosunetuzumab administered on Day 1 of the second dosing cycle, wherein the C2D1 is about 60 mg;
- and
- (c) the third to eighth dosing cycles each comprises a single dose (C3D1-C8D1) of mosunetuzumab administered on Day 1 of each respective dosing cycle, wherein each of the C3D1-C8D1 is about 30 mg.
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A method of achieving an objective response, a complete response, or progression-free survival in a subject aged about 65 years or older having an R/R NHL, wherein the method comprises intravenously administering to the subject mosunetuzumab in a dosing regimen comprising eight 21-day dosing cycles, wherein:
- (a) the first three-dose dosing cycle comprises a first dose (C1D1), a second dose (C1D2), and a third dose (C1D3) of mosunetuzumab administered on Days 1, 8, and 15, respectively, of the first dosing cycle, wherein the C1 D1 is about 1 mg, the C1 D2 is about 2 mg, and the C1 D3 is about 60 mg;
- (b) the second dosing cycle comprises a single dose (C2D1) of mosunetuzumab administered on Day 1 of the second dosing cycle, wherein the C2D1 is about 60 mg;
- and
- (c) the third to eighth dosing cycles each comprises a single dose (C3D1-C8D1) of mosunetuzumab administered on Day 1 of each respective dosing cycle, wherein each of the C3D1-C8D1 is about 30 mg.
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Dependencies are inferred from the claim text.