falsefalse

Sacituzumab Tirumotecan Plus Tagitanlimab Receives Breakthrough Therapy Designation in China for First-Line, Nonsquamous NSCLC

China’s Center for Drug Evaluation granted breakthrough therapy designation to sacituzumab tirumotecan for nonsquamous non–small cell lung cancer.

 Image by  Ashling Wahner & MJH Life  Sciences Using AI

Image by
Ashling Wahner & MJH Life
Sciences Using AI

China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted breakthrough therapy designation to the TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan in combination with tagitanlimab for the first-line treatment of patients with locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) that does not harbor actionable genomic alterations.1

The regulatory decision was supported by efficacy and safety data from the nonsquamous cohort of the phase 2 OptiTROP-Lung01 trial (NCT05351788). Findings from this cohort presented at the 2025 ASCO Annual Meeting showed that in the overall patient population (n = 81), sacituzumab tirumotecan plus tagitanlimab generated a confirmed overall response rate (ORR) of 59.3% (95% CI, 47.8%-70.1%) and a disease control rate of 91.4% (95% CI, 83.0%-96.5%).

The median duration of response (DOR) was 16.5 months (95% CI, 11.7-22.1), and the 12-month DOR rate was 64.1% (95% CI, 45.9%-77.5%). The median progression-free survival (PFS) was 15.0 months (95% CI, 10.8-24.8), and the 12-month PFS rate was 59.9% (95% CI, 47.1%-70.5%).

“This designation by the NMPA highlights the importance of developing novel therapeutic options for diverse NSCLC subtypes,” Michael Ge, chief executive officer of Kelun-Biotech, stated in a news release.1 “Sacituzumab tirumotecan in combination with tagitanlimab demonstrated clinically meaningful outcomes in key end points for patients with nonsquamous NSCLC without actionable genomic alterations as a first-line treatment. We are excited about the therapeutic potential of TROP2 ADC [and] immunotherapy combinations, and we look forward to working with regulatory authorities in China to bring this combination therapy to patients in need as soon as possible.”

The NMPA previously granted breakthrough therapy designation to sacituzumab tirumotecan for locally advanced or metastatic triple-negative breast cancer (TNBC); EGFR-mutant, locally advanced or metastatic NSCLC after progression on an EGFR TKI; locally advanced or metastatic hormone receptor–positive, HER2-negative breast cancer after at least two lines of systemic chemotherapy; and the first-line treatment of unresectable locally advanced, recurrent or metastatic, PD-L1–negative TNBC.

OptiTROP-Lung01 Overview

The study enrolled patients with advanced NSCLC who were naïve to systemic therapy and harbored no actionable mutations.2 All patients were treated with sacituzumab tirumotecan at 5 mg/kg plus tagitanlimab once every 3 weeks (n = 63) or once every 2 weeks in a nonrandomized fashion. Treatment continued until disease progression or unacceptable toxicity.

Investigator-assessed confirmed ORR per RECIST 1.1 criteria served as the trial’s primary end point.

Additional data showed that confirmed ORR increased among patients with higher PD-L1 expression. The confirmed ORR was 47.1% (95% CI, 29.8%-64.9%) in patients with a PD-L1 tumor area positivity (TAP) score of less than 1% (n = 34); 68.1% (95% CI, 52.9%-80.9%) in patients with a PD-L1 TPS of at least 1% (n = 47), and 77.8% (95% CI, 57.7%-91.4%) in those with a PD-L1 TPS of at least 50% (n = 27).

The median PFS was 12.4 months (95% CI, 7.6-15.4) in those with a PD-L1 TPS of less than 1% and 17.8 months (95% CI, 14.5-not evaluable) in patients with a PD-L1 TPS of at least 1%.

Regarding safety, any-grade treatment-related adverse effects (TRAEs) occurred in 96.3% of patients. The rates of grade 3 or higher TRAEs and serious TRAES were 60.5% and 18.5%, respectively. TRAEs led to dose reductions of sacituzumab tirumotecan in 37.0% of patients and interruption of sacituzumab tirumotecan in 45.7%.

The most common TRAEs reported in at least 20% of patients included anemia (any-grade, 80.2%; grade ≥3, 16.0%), decreased neutrophil count (63.0%; 45.7%), decreased white blood cell count (63.0%; 45.7%), stomatitis (53.1%; 11.1%), alopecia (49.4%; 0%), rash (34.6%; 8.6%), decreased appetite (33.3%; 1.2%), nausea (25.9%; 0%), fatigue (25.9%; 0%), and increased alanine aminotransferase levels (21.0%; 2.5%).

References

  1. Kelun-Biotech announces breakthrough therapy designation granted for sacituzumab tirumotecan (Sac-TMT) in combination with tagitanlimab in China for certain types of non-small cell lung cancer. News release. Kelun-Biotech. June 10, 2025. Accessed June 11, 2025. https://www.prnewswire.com/news-releases/kelun-biotech-announces-breakthrough-therapy-designation-granted-for-sacituzumab-tirumotecan-sac-tmt-in-combination-with-tagitanlimab-in-china-for-certain-types-of-non-small-cell-lung-cancer-302478438.html
  2. Fang W, Wang Q, Cheng Y, et al. Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study. J Clin Oncol. 2025;43(suppl 16):8529. doi:10.1200/JCO.2025.43.16_suppl.8529

x