The University of North Carolina at Chapel Hill

Genecentric Therapeutics, Inc.

Hawazin Faruki

Charles M Perou

Myla Lai-Goldman

Greg Mayhew

David Neil Hayes

Jonathan Serody

Joel S Parker

Gregory Mayhew

Cheng Fan

Mark Miglarese

Mark R Miglarese

Methods and compositions are provided for determining a subtype of Muscle Invasive Bladder Cancer (MIBC) in an individual by detecting the expression level of at least one classifier biomarker selected from a group of gene signatures for MIBC. Also provided herein are methods and compositions for determining the response of an individual with a MIBC subtype to a therapy such as immunotherapy.

Methods for subtyping of bladder cancer

Methods and compositions are provided for determining a subtype of lung adenocarcinoma (AD) of an individual by detecting the expression level of at least one classifier biomarker selected from a group of gene signatures for lung adenocarcinoma. Also provided herein are methods and compositions for determining the response of an individual with an adenocarcinoma subtype to a therapy such as immunotherapy.

Methods for subtyping of lung adenocarcinoma

Methods and compositions are provided for determining a subtype of lung squamous cell carcinoma (SQ) of an individual by detecting the expression level of at least one classifier biomarker selected from a group of gene signatures for lung squamous cell carcinoma. Also provided herein are methods and compositions for determining the response of an individual with a squamous cell carcinoma subtype to a therapy such as immunotherapy.

Methods for subtyping of lung squamous cell carcinoma

Methods and compositions are provided for determining a subtype of head and neck squamous cell carcinoma (HNSCC) of an individual by detecting the expression level of at least one classifier biomarker selected from a group of gene signatures for HNSCC. Also provided herein are methods and compositions for determining the response of an individual with a HNSCC subtype to a therapy such as immunotherapy.

Methods for subtyping of head and neck squamous cell carcinoma

Methods and compositions are provided for determining a pan-cancer clustering of cluster assignment (COCA) subtype of a cancer in an individual by detecting the expression level of at least one classifier biomarker selected from a group of classifier biomarkers for COCA subtypes. Also provided herein are methods and compositions for determining the response of an individual with a COCA subtype to a therapy such as immunotherapy.

Detecting cancer cell of origin

Methods and compositions are provided for determining whether an adenocarcinoma or squamous cell carcinoma patient is likely to respond to PARP inhibitor treatment. Specifically, a method of assessing whether a patient's adenocarcinoma (AD) lung cancer subtype is terminal respiratory unit (TRU), proximal inflammatory (PI), or proximal proliferative (PP) or a patient's squamous cell carcinoma (SQ) is primitive, classical, secretory or basal is provided herein. The method entails detecting the levels of classifier biomarkers at the nucleic acid level, in an AD or SQ lung cancer sample obtained from the patient. Based in part on the levels of the classifier biomarkers, the AD lung cancer sample is classified as a TRU, PI, or PP AD sample or the SQ lung cancer sample is classified as primitive, classical, secretory or basal and a determination of whether the patient is likely to respond to PARP inhibitor treatment can be made.

Methods for determining response to PARP inhibitors

Methods and compositions are provided for the molecular subtyping of lung cancer samples. Specifically, a method of assessing whether a patient's lung cancer subtype is adenocarcinoma, squamous cell carcinoma, or a neuroendocrine (encompassing both small cell carcinoma and carcinoid) is provided herein. A method for assessing whether a patient's lung cancer subtype is adenocarcinoma, squamous cell carcinoma, small cell carcinoma or carcinoid lung cancer is also provided. The methods provided herein entail probing the levels of the classifier biomarkers of Table 1-Table 6 or a subset thereof at the nucleic acid level, in a lung cancer sample obtained from the patient. Based in part on the levels of the classifier biomarkers, the lung cancer sample is classified as a particular lung cancer subtype.

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Durham, NC, United States of America

Hawazin Faruki