Keytruda and PD-L1: a Real-World Example of Co-development of a Drug with a Predictive Biomarker

Efficacy of pembrolizumab (pembro) monotherapy versus chemotherapy for PD-L1–positive (CPS ≥10) advanced G/GEJ cancer in the phase II KEYNOTE-059 (cohort 1) and phase III KEYNOTE-061 and KEYNOTE-062 studies.

(2020) Zev A. Wainberg et al.   JOURNAL OF CLINICAL ONCOLOGY

Efficacy and Safety of Pembrolizumab or Pembrolizumab Plus Chemotherapy vs Chemotherapy Alone for Patients With First-line, Advanced Gastric Cancer

(2020) Kohei Shitara et al.   JAMA Oncology

Use of archival versus newly collected tumor samples for assessing PD-L1 expression and overall survival: An updated analysis of KEYNOTE-010 trial

(2019) R S Herbst et al.   ANNALS OF ONCOLOGY

Efficacy and Safety of Pembrolizumab in Previously Treated Advanced Cervical Cancer: Results From the Phase II KEYNOTE-158 Study

(2019) Hyun Cheol Chung et al.   JOURNAL OF CLINICAL ONCOLOGY

Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer (KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial

(2019) Tony S K Mok et al.   LANCET

O-012The phase 3 KEYNOTE-181 study: pembrolizumab versus chemotherapy as second-line therapy for advanced esophageal cancer

(2019) J Metges et al.   ANNALS OF ONCOLOGY

Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study

(2019) Barbara Burtness et al.   LANCET

Clinical Utility of the Combined Positive Score for Programmed Death Ligand-1 Expression and the Approval of Pembrolizumab for Treatment of Gastric Cancer

(2018) Karina Kulangara et al.   ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE

PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project

(2018) Ming Sound Tsao et al.   Journal of Thoracic Oncology

Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): a randomised, open-label, controlled, phase 3 trial

(2018) Kohei Shitara et al.   LANCET

Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer

(2018) Leena Gandhi et al.   NEW ENGLAND JOURNAL OF MEDICINE

Tumor cells versus host immune cells: whose PD-L1 contributes to PD-1/PD-L1 blockade mediated cancer immunotherapy?

(2018) Fei Tang et al.   Cell and Bioscience

Pembrolizumab for patients with previously treated metastatic adenocarcinoma or squamous cell carcinoma of the esophagus: Phase 2 KEYNOTE-180 study.

(2018) Manish A. Shah et al.   JOURNAL OF CLINICAL ONCOLOGY

T-Cell–Inflamed Gene-Expression Profile, Programmed Death Ligand 1 Expression, and Tumor Mutational Burden Predict Efficacy in Patients Treated With Pembrolizumab Across 20 Cancers: KEYNOTE-028

(2018) Patrick A. Ott et al.   JOURNAL OF CLINICAL ONCOLOGY

Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study

(2018) Ezra E W Cohen et al.   LANCET

Differential regulation of PD-L1 expression by immune and tumor cells in NSCLC and the response to treatment with atezolizumab (anti–PD-L1)

(2018) Marcin Kowanetz et al.   PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

PD-L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD-L1 IHC Assay Comparison Project

(2017) Fred R. Hirsch et al.   Journal of Thoracic Oncology

First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicentre, single-arm, phase 2 study

(2017) Arjun V Balar et al.   LANCET ONCOLOGY

Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma

(2017) Joaquim Bellmunt et al.   NEW ENGLAND JOURNAL OF MEDICINE

A Prospective, Multi-institutional, Pathologist-Based Assessment of 4 Immunohistochemistry Assays for PD-L1 Expression in Non–Small Cell Lung Cancer

(2017) David L. Rimm et al.   JAMA Oncology

Development of a Companion Diagnostic for Pembrolizumab in Non–Small Cell Lung Cancer Using Immunohistochemistry for Programmed Death Ligand-1

(2016) Marisa Dolled-Filhart et al.   ARCHIVES OF PATHOLOGY & LABORATORY MEDICINE

Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial

(2016) Roy S Herbst et al.   LANCET

Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial

(2016) Tanguy Y Seiwert et al.   LANCET ONCOLOGY

Pembrolizumab for patients with PD-L1-positive advanced gastric cancer (KEYNOTE-012): a multicentre, open-label, phase 1b trial

(2016) Kei Muro et al.   LANCET ONCOLOGY

Pembrolizumab versus Chemotherapy for PD-L1–Positive Non–Small-Cell Lung Cancer

(2016) Martin Reck et al.   NEW ENGLAND JOURNAL OF MEDICINE

FDA Approval Summary: Pembrolizumab for the Treatment of Patients With Metastatic Non-Small Cell Lung Cancer Whose Tumors Express Programmed Death-Ligand 1

(2016) Joohee Sul et al.   ONCOLOGIST

PD-L1 (B7-H1) and PD-1 pathway blockade for cancer therapy: Mechanisms, response biomarkers, and combinations

(2016) Weiping Zou et al.   Science Translational Medicine

Development of a Companion Diagnostic PD-L1 Immunohistochemistry Assay for Pembrolizumab Therapy in Non–Small-cell Lung Cancer

(2016) Charlotte Roach et al.   APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY

Pembrolizumab for the Treatment of Non–Small-Cell Lung Cancer

(2015) Edward B. Garon et al.   NEW ENGLAND JOURNAL OF MEDICINE

PD-1 blockade induces responses by inhibiting adaptive immune resistance

(2014) Paul C. Tumeh et al.   NATURE

Development and Use of Integral Assays in Clinical Trials

(2012) R. L. Schilsky et al.   CLINICAL CANCER RESEARCH