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      Phase 1 trial of CV301 in combination with anti‐PD‐1 therapy in nonsquamous non‐small cell lung cancer

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          Abstract

          CV301, a poxviral‐based vaccine, has been evaluated in a phase 1 clinical trial (NCT02840994) and shown to be safe and immunologically active (phase 1a). Preclinical data support a combination of CV301 with programmed death‐1 inhibitors, which has been evaluated in the phase 1b part of this trial and is reported here. Patients with advanced nonsquamous non‐small cell lung cancer (NSCLC) without actionable genomic alterations received two priming doses of modified vaccinia Ankara‐BN‐CV301 (MVA) 4 weeks apart, followed by boosting doses of fowlpox‐CV301 (FPV) at increasing time intervals for a maximum of 17 doses in combination with nivolumab for cohort 1 (C1) and 15 doses in combination with pembrolizumab for cohort 2 (C2). The primary objective was evaluation of safety and tolerability. Between October 2017 and September 14, 2018, patients were enrolled (C1: 4; median age: 64 years). Mean treatment duration was 332 days in C1 and 289 days in C2. CTCAE ≥grade 3 adverse events (AEs) were observed in four (100%) patients in C1 and three (37.5%) patients in C2. There was one death on trial. Immune‐related AEs (irAEs) fulfilling criteria for a dose‐limiting toxicity included 1 case of pneumonitis. Among 11 evaluable patients, 1 (9%) had a complete response, 1 (9%) had a partial response and 9 (82%) had stable disease. We conclude that CV301 administered with PD‐1 inhibitors is safe and clinically active in patients with advanced NSCLC. The frequency or severity of AEs is not increased, including irAEs for each component of the combination.

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

          Pembrolizumab is a humanized monoclonal antibody against programmed death 1 (PD-1) that has antitumor activity in advanced non-small-cell lung cancer (NSCLC), with increased activity in tumors that express programmed death ligand 1 (PD-L1).
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            Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

            Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.
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              Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer

              First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial.
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                Author and article information

                Contributors
                Journal
                International Journal of Cancer
                Intl Journal of Cancer
                Wiley
                0020-7136
                1097-0215
                February 2023
                September 09 2022
                February 2023
                : 152
                : 3
                : 447-457
                Affiliations
                [1 ] Thoracic and Gastrointestinal Malignancies Branch, Center for Cancer Research, National Cancer Institute National Institutes of Health Bethesda Maryland USA
                [2 ] Thoracic Oncology Moffitt Cancer Center Tampa Florida USA
                [3 ] Medical Oncology Washington University School of Medicine St. Louis Missouri USA
                [4 ] Medical Oncology Investigative Clinical Research of Indiana Indianapolis Indiana USA
                [5 ] Bavarian Nordic Morrisville North Carolina USA
                [6 ] Laboratory of Tumor Immunology and Biology, Center for Cancer Research National Cancer Institute, National Institutes of Health Bethesda Maryland USA
                [7 ] Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute National Institutes of Health Bethesda Maryland USA
                Article
                10.1002/ijc.34267
                36054490
                d4610b5d-1808-4b80-ac61-4a6bd2722f4e
                © 2023

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