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AssigneeGenentech, Inc.
InventorsHartmut Karl-Wilhelm KOEPPEN, Akshay Tilak KRISHNAMURTY, Soren MULLER, Barzin Y. NABET, Minu Kumari SRIVASTAVA
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The invention provides diagnostic methods for identifying individuals having a lung cancer (e.g., NSCLC) suitable for treatment a treatment regimen that includes a PD-1 axis binding antagonist (e.g., atezolizumab) after adjuvant therapy (e.g., after a platinum-based adjuvant therapy) and therapeutic methods for treating lung cancer (e.g., NSCLC) in an individual identified as one who may benefit from treatment with a treatment regimen that includes a PD-1 axis binding antagonist (e.g., atezolizumab) to the individual following an adjuvant therapy (e.g., after a platinum-based adjuvant therapy). Also provided are compositions (e.g., a PD-1 axis binding antagonist (e.g., atezolizumab), pharmaceutical compositions thereof, assays thereof, kits thereof, and articles of manufacture thereof) for use in identifying patients suitable for treatment and for treating lung cancer (e.g., NSCLC) in an identified individual.
A method for treating a non-small cell lung cancer (NSCLC) in an individual, the method comprising:
A method of treating an individual having an NSCLC, the method comprising administering to the individual an effective amount of an anti-PD-L1 antibody, wherein a tumor tissue sample from the individual has been determined to have an expression level of a TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from an adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC, and
A method of identifying an individual having an NSCLC who is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC, the method comprising determining the expression level of a TGFβ CAF gene signature in a tumor tissue sample obtained from the individual, wherein an expression level of the TGFβ CAF gene signature has been determined to be at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
A method for selecting a therapy for an individual having an NSCLC, the method comprising determining the expression level of a TGFβ CAF gene signature in a tumor tissue sample obtained from the individual, wherein an expression level of the TGFβ CAF gene signature has been determined to be at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC,
A kit for identifying an individual having an NSCLC who is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC, the kit comprising reagents for determining the expression level of a TGFβ CAF gene signature in a tumor tissue sample obtained from the individual, wherein an expression level of a TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level identifies that the individual as one who is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
An assay for identifying an individual having an NSCLC who is a candidate for an adjuvant treatment comprising an anti-PD-L1 antibody, the assay comprising determining the expression level of a TGFβ CAF gene signature in a tumor tissue sample obtained from the individual, wherein an expression level of the TGFβ CAF gene signature has been determined to be at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
A method for treating an NSCLC in an individual, the method comprising:
A method of treating an individual having an NSCLC, the method comprising administering to the individual an effective amount of an anti-PD-L1 antibody, wherein a tumor tissue sample from the individual has been determined to have an expression level of LRRC15 that is at or above a reference LRRC15 expression level, thereby indicating that the individual is likely to have an increased clinical benefit from an adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC, and
A method of identifying an individual having an NSCLC who is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC, the method comprising determining the expression level of LRRC15 in a tumor tissue sample obtained from the individual, wherein an expression level of LRRC15 has been determined to be at or above a reference LRRC15 expression level, thereby indicating that the individual is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
A method for selecting a therapy for an individual having an NSCLC, the method comprising determining the expression level of LRRC15 in a tumor tissue sample obtained from the individual, wherein an expression level of LRRC15 has been determined to be at or above a reference LRRC15 expression level, thereby indicating that the individual is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC,
A kit for identifying an individual having an NSCLC who is likely to have an increased clinical benefit from an adjuvant treatment comprising an anti-PD-L1 antibody compared to treatment with BSC, the kit comprising reagents for determining the expression level of LRRC15 in a tumor tissue sample obtained from the individual, wherein an expression level of LRRC15 that is at or above a reference LRRC15 expression level identifies that the individual as one who is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
An assay for identifying an individual having an NSCLC who is a candidate for an adjuvant treatment comprising an anti-PD-L1 antibody, the assay comprising determining the expression level of LRRC15 in a tumor tissue sample obtained from the individual, wherein an expression level of LRRC15 has been determined to be at or above a reference LRRC15 expression level, thereby indicating that the individual is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC,
A pharmaceutical composition comprising an anti-PD-L1 antibody for use in an adjuvant treatment of an individual having an NSCLC, wherein the adjuvant treatment comprises administration of an effective amount of the anti-PD-L1 antibody, wherein a tumor tissue sample obtained from the individual has been determined to have an expression level of an TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from treatment with the anti-PD-L1 antibody compared to treatment with BSC, and
Use of an anti-PD-L1 antibody in the manufacture of a medicament for adjuvant treatment of an individual having an NSCLC, wherein the adjuvant treatment comprises administration of an effective amount of the anti-PD-L1 antibody, wherein a tumor tissue sample obtained from the individual has been determined to have an expression level of an TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from treatment with the anti-PD-L1 antibody compared to treatment with BSC, and
An article of manufacture comprising an anti-PD-L1 antibody and instructions to administer the anti-PD-L1 antibody for adjuvant treatment of an individual having an NSCLC, wherein the adjuvant treatment comprises administration of an effective amount of the anti-PD-L1 antibody, wherein a tumor tissue sample obtained from the individual has been determined to have an expression level of an TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased clinical benefit from the adjuvant treatment comprising the anti-PD-L1 antibody compared to treatment with BSC, and
A method of treating an individual comprising administering to the individual an adjuvant treatment comprising an effective amount of atezolizumab following complete resection and no progression after platinum-based chemotherapy for an individual with stage IB to IIIA NSCLC, wherein a tumor tissue sample obtained from the individual has been determined to have an expression level of an TGFβ CAF gene signature that is at or above a reference TGFβ CAF gene signature expression level, thereby indicating that the individual is likely to have an increased DFS and/or OS after the adjuvant treatment comprising the atezolizumab compared to treatment with BSC,
A method of treating an individual comprising administering to the individual an adjuvant treatment comprising an effective amount of atezolizumab following complete resection and no progression after platinum-based chemotherapy for an individual with stage IB to IIIA NSCLC, wherein the tumor tissue sample from the individual has been determined to have an RNA expression level of LRRC15 that is at or above a median RNA expression level of LRRC15 in a reference population of individuals having stage IB to IIIA NSCLC, thereby indicating that the individual is likely to have an increased DFS and/or OS after adjuvant treatment comprising the atezolizumab compared to treatment with BSC.
Dependencies are inferred from the claim text.