US 11,674,962 B2
Therapeutic and diagnostic methods for cancer
Craig Anthony Cummings, South San Francisco, CA (US); Yan Li, South San Francisco, CA (US); Sarah Margaret Shagan, South San Francisco, CA (US); Erica Beth Schleifman, South San Francisco, CA (US); David Shames, South San Francisco, CA (US); David Fabrizio, Cambridge, MA (US); Daniel Lieber, Cambridge, MA (US); Geoffrey Alan Otto, Cambridge, MA (US); Mark Kennedy, Cambridge, MA (US); Travis Clark, Cambridge, MA (US); Doron Lipson, Cambridge, MA (US); Jie He, Cambridge, MA (US); and Shan Zhong, Belmont, MA (US)
Assigned to Genentech, Inc., South San Francisco, CA (US); and Foundation Medicine, Inc., Cambridge, MA (US)
Filed by Genentech, Inc., South San Francisco, CA (US); and Foundation Medicine, Inc., Cambridge, MA (US)
Filed on Jul. 20, 2018, as Appl. No. 16/41,363.
Claims priority of provisional application 62/680,516, filed on Jun. 4, 2018.
Claims priority of provisional application 62/652,843, filed on Apr. 4, 2018.
Claims priority of provisional application 62/553,034, filed on Aug. 31, 2017.
Claims priority of provisional application 62/535,605, filed on Jul. 21, 2017.
Prior Publication US 2019/0025308 A1, Jan. 24, 2019
Int. Cl. C12Q 1/68 (2018.01); C12Q 1/6883 (2018.01); G01N 33/574 (2006.01); C07K 16/28 (2006.01); G16H 50/50 (2018.01); G16H 50/30 (2018.01); G16H 50/70 (2018.01); G16H 50/20 (2018.01); A61P 35/00 (2006.01); G06F 16/28 (2019.01); C07K 14/735 (2006.01); A61K 39/00 (2006.01)
CPC G01N 33/574 (2013.01) [A61P 35/00 (2018.01); C07K 14/70535 (2013.01); C07K 16/2827 (2013.01); C07K 16/2896 (2013.01); C12Q 1/68 (2013.01); C12Q 1/6883 (2013.01); G01N 33/57492 (2013.01); G06F 16/285 (2019.01); G16H 50/20 (2018.01); G16H 50/30 (2018.01); G16H 50/50 (2018.01); G16H 50/70 (2018.01); A61K 2039/505 (2013.01); A61K 2039/55 (2013.01); C07K 2317/24 (2013.01); C12Q 2600/156 (2013.01); G01N 2333/70532 (2013.01); G01N 2800/52 (2013.01)] 16 Claims
 
1. A method of treating an individual having locally advanced NSCLC or metastatic NSCLC, the method comprising administering to the individual an effective amount of atezolizumab, wherein a bTMB score that is at or above a reference bTMB score has been determined from a blood sample obtained from the individual prior to administration of atezolizumab to the individual, thereby identifying the individual as one who may benefit from a treatment comprising atezolizumab, wherein the reference bTMB score is 16,
wherein the blood sample comprises an aggregate set of DNA fragments released into the blood by tumor cells present in the individual,
wherein the bTMB score is represented as the number of somatic mutations counted over a defined number of sequenced bases of between about 100 kb to about 10 Mb, and
wherein the benefit from a treatment comprising atezolizumab is an increase in PFS and/or an increase in OS.