JPWO2020061349A5

JPWO2020061349A5 -

Info

Publication number: JPWO2020061349A5
Application number: JP2021513826A
Authority: JP
Publication date: 2022-09-29
Anticipated expiration: 2039-09-19

Claims

Methods for identifying patients with locally advanced or metastatic TNBC who are likely to respond to treatment with anticancer therapies comprising (i) atezolizumab and (ii) nab- paclitaxel wherein said method comprises determining the expression level of PD-L1 in tumor-infiltrating immune cells in a tumor sample obtained from said patient, wherein said patient has previously been treated for said TNBC said patient is likely to respond to treatment with said anti-cancer therapy due to a detectable level of PD-L1 expression in tumor-infiltrating immune cells comprising about 1% or more of said tumor sample without The method as identified above.

A method for selecting an anti-cancer therapy for a patient suffering from locally advanced or metastatic TNBC, comprising:
The method includes
(a) determining the expression level of PD-L1 in tumor-infiltrating immune cells in a tumor sample obtained from said patient who has not previously received treatment for said TNBC;
(b) said patient comprising (i) atezolizumab and (ii) nab-paclitaxel , based on detectable levels of PD-L1 expression in tumor-infiltrating immune cells comprising about 1% or more of said tumor sample. and selecting an anti-cancer therapy for.

The tumor sample obtained from said patient has a detectable expression level of PD-L1 in (i) about 5% or more of said tumor sample or (ii) about 10% or more of said tumor sample in tumor-infiltrating immune cells. 3. The method of claim 1 or 2 , comprising:

4. The method of any one of claims 1-3 , wherein the patient has not previously received chemotherapy or systemic targeted therapy for inoperable locally advanced or metastatic TNBC.

The method of any one of claims 1-4 , wherein the locally advanced TNBC is unresectable.

6. The method of any one of claims 1-5 , wherein the tumor sample is a formalin-fixed paraffin-embedded (FFPE) tumor sample, an archival tumor sample, a fresh tumor sample, or a frozen tumor sample.

The method of any one of claims 1-6 , wherein the expression level of PD-L1 is a protein expression level.

8. The method of claim 7 , wherein the PD-L1 protein expression level is determined using immunohistochemistry (IHC), immunofluorescence, flow cytometry, or Western blot.

9. The method of claim 8 , wherein the PD-L1 protein expression level is determined using IHC.

10. The method of claim 8 or 9 , wherein the PD-L1 protein expression level is detected using an anti-PD-L1 antibody.

11. The method of claim 10 , wherein said anti-PD-L1 antibody is SP142.

12. The method of any one of claims 1-11 , wherein whether the patient is likely to respond to treatment with the anti-cancer therapy is determined in terms of progression-free survival.

13. The method of any one of claims 1-12 , wherein whether the patient is likely to respond to treatment with the anti-cancer therapy is determined in terms of overall survival.

A pharmaceutical composition comprising atezolizumab for use in treating a patient diagnosed with locally advanced or metastatic TNBC, said treatment comprising administration of said atezolizumab in combination with nab-paclitaxel , said patient responds to anti-cancer therapy comprising said atezolizumab and nab- paclitaxel based on detectable levels of PD-L1 expression in tumor-infiltrating immune cells comprising about 1% or more of tumor samples obtained from said patient Said pharmaceutical composition identified as having high potential.

(a) a tumor sample obtained from said patient has detectable expression of PD-L1 in tumor-infiltrating immune cells comprising (i) about 5% or more of the tumor sample, or (ii) about 10% or more of the tumor sample; have a level;
(b) said patient has not previously received chemotherapy or systemic targeted therapy for inoperable locally advanced or metastatic TNBC ;
(c) said locally advanced TNBC is unresectable ;
(d) the tumor sample is an FFPE tumor sample, an archival tumor sample, a fresh tumor sample, or a frozen tumor sample;
(e) the PD-L1 expression level is the protein expression level, and the PD-L1 protein expression level may be determined using IHC, immunofluorescence, flow cytometry, or Western blot; - The protein expression level of L1 may be determined using IHC, and the protein expression level of PD-L1 may be detected using an anti-PD-L1 antibody, and an anti-PD-L1 antibody may be SP142;
(f) whether said patient is likely to respond to treatment with said anti-cancer therapy is determined in terms of progression-free survival; and/or
(g) whether said patient is likely to respond to treatment with said anti-cancer therapy is determined in terms of overall survival ;
15. A pharmaceutical composition according to claim 14 .