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<p>PRESERVE-003 is a two-stage phase 3 trial evaluating gotistobart (BNT316/ONC-392), a novel pH-sensitive anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody that selectively depletes regulatory T cells within the tumor microenvironment, in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on programmed cell death protein/programmed death ligand 1 inhibitor/platinum-based chemotherapy—a population with a poor prognosis. Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel. Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg<sup>−1</sup> with two 10 mg kg<sup>−1</sup> loading doses every 3 weeks (<i>N</i> = 45)) or docetaxel (75 mg m<sup>−</sup><sup>2</sup> every 3 weeks (<i>N</i> = 42)). After a median follow-up of 14.5 months, median overall survival was not reached with gotistobart (95% confidence interval (CI) 9.3 to not evaluable) versus 10.0 months (95% CI 6.2 to 11.9 months) with docetaxel (hazard ratio 0.46, 95% CI 0.25 to 0.84, nominal two-sided <i>P</i> = 0.0102). Safety was manageable, with grade ≥3 treatment-related adverse events in 42% and 49% of patients receiving gotistobart and docetaxel, respectively. Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: <a href="https://clinicaltrials.gov/search?term=NCT05671510">NCT05671510</a>.</p>

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Gotistobart or docetaxel in metastatic squamous non-small cell lung cancer: stage 1 of the randomized phase 3 PRESERVE-003 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月27日

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  • Byoung Chul Cho,
  • Rama Balaraman,
  • Hua-Jun Chen,
  • Xinmin Yu,
  • Adewale Fawole,
  • Zhi-gang Liu,
  • Jiliang Zhang,
  • Long Wu,
  • Bin Yang,
  • Jennifer L. Leddon,
  • John Hamm,
  • Yanjing Huang,
  • Lin Wu,
  • Pinhua Pan,
  • Preet Singh,
  • Andrew Beardsley,
  • Fadi Kayali,
  • Ardalan Davarifar,
  • Ki Hyeong Lee,
  • Keon-Uk Park,
  • Youngjoo Lee,
  • Luchun Li,
  • Xicheng Wang,
  • Meili Sun,
  • Yan Yu,
  • Vikram Jain,
  • Svetlana Shpyro,
  • Qiong Wang,
  • Michael Wenger,
  • Uğur Şahin,
  • Sergey Efuni,
  • Shiling Song,
  • Kun He,
  • Pan Zheng,
  • Yang Liu,
  • Kai He,
  • Tianhong Li,
  • Mark A. Socinski,
  • Yi-Long Wu

摘要

PRESERVE-003 is a two-stage phase 3 trial evaluating gotistobart (BNT316/ONC-392), a novel pH-sensitive anti-cytotoxic T lymphocyte-associated protein 4 (CTLA-4) antibody that selectively depletes regulatory T cells within the tumor microenvironment, in patients with metastatic squamous non-small cell lung cancer (sqNSCLC) without actionable genomic alterations who progressed on programmed cell death protein/programmed death ligand 1 inhibitor/platinum-based chemotherapy—a population with a poor prognosis. Here we report on stage 1, which aimed to confirm the dose and assess the preliminary efficacy (primary outcome: overall survival; secondary outcomes: progression‑free survival, objective response rate and duration of response) and safety of gotistobart compared to docetaxel. Patients with sqNSCLC were randomized (1:1) to gotistobart (6 mg kg−1 with two 10 mg kg−1 loading doses every 3 weeks (N = 45)) or docetaxel (75 mg m−2 every 3 weeks (N = 42)). After a median follow-up of 14.5 months, median overall survival was not reached with gotistobart (95% confidence interval (CI) 9.3 to not evaluable) versus 10.0 months (95% CI 6.2 to 11.9 months) with docetaxel (hazard ratio 0.46, 95% CI 0.25 to 0.84, nominal two-sided P = 0.0102). Safety was manageable, with grade ≥3 treatment-related adverse events in 42% and 49% of patients receiving gotistobart and docetaxel, respectively. Stage 1 results suggest that gotistobart monotherapy can provide clinically meaningful benefit for patients with programmed cell death protein/programmed death ligand 1-resistant and chemotherapy-resistant metastatic sqNSCLC. ClinicalTrials.gov identifier: NCT05671510.