US 12,291,575 B2
Methods for treatment of CD20-positive proliferative disorder with mosunetuzumab and polatuzumab vedotin
Carol Elaine O'Hear, South San Francisco, CA (US); Yasuhiro Oki, South San Francisco, CA (US); and Iris Tranthuyngan To, South San Francisco, CA (US)
Assigned to Genentech, Inc., South San Francisco, CA (US)
Filed by Genentech, Inc., South San Francisco, CA (US)
Filed on May 13, 2022, as Appl. No. 17/744,262.
Claims priority of provisional application 63/292,887, filed on Dec. 22, 2021.
Claims priority of provisional application 63/188,695, filed on May 14, 2021.
Prior Publication US 2022/0411528 A1, Dec. 29, 2022
Int. Cl. A61P 35/00 (2006.01); C07K 16/28 (2006.01); A61K 39/00 (2006.01)
CPC C07K 16/2887 (2013.01) [A61P 35/00 (2018.01); C07K 16/2866 (2013.01); C07K 16/2896 (2013.01); A61K 2039/507 (2013.01); A61K 2039/545 (2013.01)] 43 Claims
 
1. A method of treating a subject having a B cell proliferative disorder comprising subcutaneously administering to the subject mosunetuzumab and intravenously administering to the subject polatuzumab vedotin in a dosing regimen comprising at least a first 21-day dosing cycle and a second 21-day dosing cycle, wherein:
(a) the first dosing cycle comprises a first dose (C1D1) of mosunetuzumab, a second dose (C1D2) of the mosunetuzumab, a third dose (C1D3) of mosunetuzumab, and a first dose (C1D1) of polatuzumab vedotin, wherein the C1D1 of mosunetuzumab is 5 mg, the C1D2 of mosunetuzumab is 15 mg, and the C1D3 of mosunetuzumab is 45 mg, and wherein the C1D1 of polatuzumab vedotin is 1.8 mg/kg; and
(b) the second dosing cycle comprises a single dose (C2D1) of mosunetuzumab and a single dose (C2D1) of polatuzumab vedotin, wherein the C2D1 of mosunetuzumab is 45 mg, and wherein the C2D1 of polatuzumab vedotin is 1.8 mg/kg, and
wherein the C1D1, C1D2, and C1D3 of mosunetuzumab are administered on or about Days 1, 8, and 15, respectively, of the first dosing cycle, the C1D1 of polatuzumab vedotin is administered on Day 1 of the first dosing cycle, the C2D1 of polatuzumab vedotin is administered on Day 1 of the second dosing cycle, and the C1D1 of polatuzumab vedotin is administered prior to administration of the C1D1 of mosunetuzumab.