Joseph Fiore

Overall Survival with Neoadjuvant Nivolumab plus Chemotherapy in Lung Cancer

Patrick M. Forde, Jonathan Spicer, Mariano Provencio, Tetsuya Mitsudomi et autres

BACKGROUND: Neoadjuvant nivolumab plus chemotherapy significantly improved pathological complete response and event-free survival in patients with resectable non-small-cell lung cancer (NSCLC) in a phase 3 trial. Data are needed on overall survival. METHODS: In this open-label, phase 3 trial, patients with stage …

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Concordance of Whole-Slide Imaging and Conventional Light Microscopy for Assessment of Pathologic Response Following Neoadjuvant Therapy for Lung Cancer

Julie S. Deutsch, Daphne Wang, Krista Y. Chen, Ashley Cimino‐Mathews et autres

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Pathological response in resectable non–small cell lung cancer: a systematic literature review and meta-analysis

Nathalie Waser, Melanie Quintana, Bernd Schweikert, Jamie E. Chaft et autres

BACKGROUND: Surrogate endpoints for overall survival in patients with resectable non-small cell lung cancer receiving neoadjuvant therapy are needed to provide earlier treatment outcome indicators and accelerate drug approval. This study's main objectives were to investigate the association among pathological complete response, …

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Real-World Relationship of Early End Points to Survival End Points in Patients with Resectable Non-Small-Cell Lung Cancer

Eric Nadler, Anupama Vasudevan, Chuck Wentworth, Nicholas J. Robert et autres

Aim: Pathologic response has been shown to be a promising surrogate for survival in non-small-cell lung cancer (NSCLC). We examined the real-world relationship between these end points in patients with resectable stage IB-IIIA NSCLC receiving neoadjuvant chemotherapy/chemoradiotherapy (CT/CRT). Methods: Electronic health records/medical …

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Plain language summary of the CheckMate 816 study results: nivolumab plus chemotherapy given before surgery for non–small-cell lung cancer

Patrick M. Forde, Jonathan Spicer, Shun Lu, Mariano Provencio et autres

What is this summary about? In this article, we summarize results from the ongoing phase 3 CheckMate 816 clinical study that were published in The New England Journal of Medicine in 2022. The goal of CheckMate 816 was to find out if …

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First-line nivolumab plus ipilimumab for metastatic non-small cell lung cancer, including patients with ECOG performance status 2 and other special populations: CheckMate 817

Neal Ready, Clarisse Audigier-Valette, Jonathan W. Goldman, Enriqueta Felip et autres

BACKGROUND: CheckMate 817, a phase 3B study, evaluated flat-dose nivolumab plus weight-based ipilimumab in patients with metastatic non-small cell lung cancer (NSCLC). Here, in this research, we report on first-line treatment in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) …

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Emulating Randomized Controlled Trials with Hybrid Control Arms in Oncology: A Case Study

Sanhita Sengupta, Ives Ntambwe, Katherine Tan, Qixing Liang et autres

This proof-of-concept study retrospectively assessed the feasibility of applying a hybrid control arm design to a completed phase III randomized controlled trial (RCT; CheckMate-057) in advanced non-small cell lung cancer using a real-world data (RWD) source. The emulated trial consists of an …

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LBA50 Analysis of pathological features and efficacy outcomes with neoadjuvant nivolumab (N) plus platinum-doublet chemotherapy (C) for resectable non-small cell lung cancer (NSCLC) in CheckMate 816

Julie S. Deutsch, Ashley Cimino‐Mathews, Elizabeth D. Thompson, Dong‐An Wang et autres

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Changes in Circulating Tumor DNA Reflect Clinical Benefit Across Multiple Studies of Patients With Non–Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors

Diana Merino Vega, Katherine K. Nishimura, Névine Zariffa, Jeffrey C. Thompson et autres

PURPOSE: As immune checkpoint inhibitors (ICI) become increasingly used in frontline settings, identifying early indicators of response is needed. Recent studies suggest a role for circulating tumor DNA (ctDNA) in monitoring response to ICI, but uncertainty exists in the generalizability of these …

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Abstract CT003: Nivolumab (NIVO) + platinum-doublet chemotherapy (chemo) vs chemo as neoadjuvant treatment (tx) for resectable (IB-IIIA) non-small cell lung cancer (NSCLC) in the phase 3 CheckMate 816 trial

Patrick M. Forde, Jonathan Spicer, Shun Lü, Mariano Provencio et autres

Abstract Background In patients (pts) with non-metastatic NSCLC, surgery has curative potential but 30-80% who undergo resection experience recurrence. Neoadjuvant or adjuvant chemo is recommended for pts with high recurrence risk; however, benefits are modest and pathological complete response (pCR) with neoadjuvant …

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Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: experience from clinical trials and post-marketing surveillance

Joseph Fiore, Maribel Miranda Co-van der Mee, Andrés A. Maldonado, Lisa Glasser et autres

An adjuvanted recombinant zoster vaccine (RZV) is licensed for the prevention of herpes zoster. This paper reviews its safety and reactogenicity. A pooled analysis of two pivotal randomized Phase-3 trials (NCT01165177, NCT01165229) in adults ⩾50 years found that more solicited adverse events …

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OA04.02 CheckMate 817: First-Line Nivolumab + Ipilimumab in Patients with ECOG PS 2 and Other Special Populations with Advanced NSCLC

Fabrice Barlési, Clarisse Audigier-Valette, Enriqueta Felip, Tudor–Eliade Ciuleanu et autres

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