Bintrafusp Alfa With CCRT Followed by Bintrafusp Alfa Versus Placebo With CCRT Followed by Durvalumab in Patients With Unresectable Stage III NSCLC: A Phase 2 Randomized Study

Everett E. Vokes, Francoise Mornex, Ahmet Sezer, Ying Cheng, Jian Fang, David Vicente Baz, Timucin Cil, Alex A. Adjei, Myung Ju Ahn, Fabrice Barlesi, Enriqueta Felip, Edward B. Garon, Francois Audhuy, Rena Ito, Masashi Sato, S. Peter Eggleton, Claudio Marcelo Martin, Martin Reck, Clifford G. Robinson, Luis Paz-Ares

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1 Scopus citations

Abstract

Introduction: Preclinical evaluation of bintrafusp alfa (BA) combined with radiotherapy revealed greater antitumor effects than BA or radiotherapy alone. In a phase 1 study, BA exhibited encouraging clinical activity in patients with stage IIIB or IV NSCLC who had received previous treatment. Methods: This multicenter, double-blind, controlled phase 2 study (NCT03840902) evaluated the safety and efficacy of BA with concurrent chemoradiotherapy (cCRT) followed by BA (BA group) versus placebo with cCRT followed by durvalumab (durvalumab group) in patients with unresectable stage III NSCLC. The primary end point was progression-free survival according to Response Evaluation Criteria in Solid Tumors version 1.1 as assessed by the investigator. On the basis of the recommendation of an independent data monitoring committee, the study was discontinued before the maturity of overall survival data (secondary end point). Results: A total of 153 patients were randomized to either BA (n = 75) or durvalumab groups (n = 78). The median progression-free survival was 12.8 months versus 14.6 months (stratified hazard ratio = 1.48 [95% confidence interval: 0.69–3.17]), in the BA and durvalumab groups, respectively. Trends for overall response rate (29.3% versus 32.1%) and disease control rate (66.7% versus 70.5%) were similar between the two groups. Any-grade treatment-emergent adverse events occurred in 94.6% versus 96.1% of patients in the BA versus durvalumab groups, respectively. Bleeding events in the BA group were mostly grade 1 (21.6%) or 2 (9.5%). Conclusions: BA with cCRT followed by BA exhibited no efficacy benefit over placebo with cCRT followed by durvalumab in patients with stage III unresectable NSCLC.

Original languageEnglish
Pages (from-to)285-296
Number of pages12
JournalJournal of Thoracic Oncology
Volume19
Issue number2
DOIs
StatePublished - Feb 2024

Keywords

  • Bifunctional
  • Bintrafusp alfa
  • Concurrent chemoradiotherapy
  • Non–small cell lung cancer
  • TGF-β

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