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Background <p>Thyroid transcription factor-1 (TTF-1) has emerged as a novel predictive biomarker associated with the prognosis and treatment response of non-squamous non-small-cell lung cancer (NSCLC) to cytotoxic chemotherapy. This study evaluated the clinical significance of TTF-1 expression in advanced NSCLC with programmed death-ligand 1 (PD-L1) &lt; 1%, with a specific focus on its utility in stratifying treatment outcomes between dual immune checkpoint inhibitor (IO–IO) therapy and chemoimmunotherapy.</p> Methods <p>We conducted a multicenter retrospective study across 22 Japanese institutions, evaluating 194 patients with advanced or recurrent non-squamous NSCLC and PD-L1 &lt; 1% treated with IO–IO therapy or chemoimmunotherapy between 2019 and 2022. Survival outcomes were analyzed using multivariable Cox regression.</p> Results <p>TTF-1-positive patients had significantly longer progression-free survival (PFS) and overall survival (OS) than TTF-1-negative patients [adjusted hazard ratio (HR) for PFS: 0.65, <i>p</i> = 0.009; adjusted HR for OS: 0.69, <i>p</i> = 0.04]. Among TTF-1-positive patients, no significant difference in survival was observed between IO–IO therapy and chemoimmunotherapy. By contrast, TTF-1-negative patients experienced significantly improved outcomes with chemoimmunotherapy than with IO–IO therapy (adjusted HR for PFS: 0.37, <i>p</i> = 0.01; adjusted HR for OS: 0.39, <i>p</i> = 0.02).</p> Conclusion <p>TTF-1 expression may serve as a prognostic and potentially predictive biomarker in PD-L1-negative NSCLC patients. TTF-1-negative patients appeared to derive greater benefit from the addition of chemotherapy. These findings suggest that TTF-1 expression may have potential utility in guiding treatment selection and warrant prospective validation.</p>

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Predictive value of TTF-1 expression for stratifying outcomes between dual ICI and chemoimmunotherapy in patients with PD-L1-negative NSCLC

  • 期刊论文

  • 发表日期：

    2026年8月4日

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  • Naoya Nishioka,
  • Daiki Murata,
  • Koichi Azuma,
  • Kazuhiro Ito,
  • Takashi Nomizo,
  • Kazuhiko Yamada,
  • Tatsuya Imabayashi,
  • Kentaro Iwanaga,
  • Kenji Chibana,
  • Takayo Ota,
  • Yuuya Nishii,
  • Akira Nakao,
  • Asuka Okada,
  • Kosuke Hamai,
  • Takenori Sakai,
  • Taishi Harada,
  • Keiko Tanimura,
  • Kohei Yoshimine,
  • Yosuke Tamura,
  • Ryuichiro Takaki,
  • Yasuhiro Goto,
  • Makoto Hibino,
  • Tomohiro Oba,
  • Toshiyuki Sumi,
  • Hiroyasu Kaneda,
  • Tadaaki Yamada,
  • Koichi Takayama

摘要

Background

Thyroid transcription factor-1 (TTF-1) has emerged as a novel predictive biomarker associated with the prognosis and treatment response of non-squamous non-small-cell lung cancer (NSCLC) to cytotoxic chemotherapy. This study evaluated the clinical significance of TTF-1 expression in advanced NSCLC with programmed death-ligand 1 (PD-L1) < 1%, with a specific focus on its utility in stratifying treatment outcomes between dual immune checkpoint inhibitor (IO–IO) therapy and chemoimmunotherapy.

Methods

We conducted a multicenter retrospective study across 22 Japanese institutions, evaluating 194 patients with advanced or recurrent non-squamous NSCLC and PD-L1 < 1% treated with IO–IO therapy or chemoimmunotherapy between 2019 and 2022. Survival outcomes were analyzed using multivariable Cox regression.

Results

TTF-1-positive patients had significantly longer progression-free survival (PFS) and overall survival (OS) than TTF-1-negative patients [adjusted hazard ratio (HR) for PFS: 0.65, p = 0.009; adjusted HR for OS: 0.69, p = 0.04]. Among TTF-1-positive patients, no significant difference in survival was observed between IO–IO therapy and chemoimmunotherapy. By contrast, TTF-1-negative patients experienced significantly improved outcomes with chemoimmunotherapy than with IO–IO therapy (adjusted HR for PFS: 0.37, p = 0.01; adjusted HR for OS: 0.39, p = 0.02).

Conclusion

TTF-1 expression may serve as a prognostic and potentially predictive biomarker in PD-L1-negative NSCLC patients. TTF-1-negative patients appeared to derive greater benefit from the addition of chemotherapy. These findings suggest that TTF-1 expression may have potential utility in guiding treatment selection and warrant prospective validation.