Meta-analysis of pucotenlimab shows improved outcomes across multiple solid tumors

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Cancer medicine Published May 1, 2026 Medically reviewed May 1, 2026 Study authors: He Yingge, Gao Changqing, Zhang Shiyan, Hao Yonghui, He Shuning, Peng Ke, Li Liqi PubMed ↗ DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider pucotenlimab as a potential option across multiple solid tumors, with efficacy varying by tumor type and combination regimen.

This meta-analysis assessed the efficacy and safety of pucotenlimab (HX008) across several solid tumor types, including gastric/gastroesophageal junction cancer, triple-negative breast cancer (TNBC), melanoma, and dMMR/MSI-H solid tumors. The analysis compared pucotenlimab-based regimens versus control treatments.

Key findings demonstrated significantly improved outcomes with pucotenlimab: overall response rate (ORR) odds ratio 4.82 (95% CrI: 3.65-6.38), progression-free survival hazard ratio 0.41 (95% CrI: 0.32-0.52), and overall survival hazard ratio 0.37 (95% CrI: 0.26-0.51). Combination therapy showed superior efficacy over monotherapy (ORR OR 5.91 vs. 2.35).

Response rates varied by tumor type and regimen. In TNBC patients receiving gemcitabine/cisplatin, ORR was 80.6% (95% CrI: 62.5%-92.6%). In mucosal melanoma, ORR was 8.7% (95% CrI: 1.1%-28.0%). For gastric/gastroesophageal junction cancer, oxaliplatin/capecitabine yielded ORR 60.0% and HR 0.45, while irinotecan yielded ORR 27.6%.

The analysis identified subgroups with differential benefit: a high-benefit group had ORR 78.2%, while a low-benefit group had ORR 28.3%. Immune-related adverse events (irAEs) occurred in 41.2% of a high-risk group (grade ≥3) and 3.5% in a low-risk group.

Limitations include unreported sample size, follow-up duration, and primary outcome. The authors note the analysis defines precise application scenarios and provides an extensible analytical paradigm, but cautious interpretation is warranted given the meta-analytic nature and variability across tumor types.

Study Details

Study typeMeta analysis

EvidenceLevel 1

PublishedMay 2026

PMID42043855

View Original Abstract ↓

The efficacy of PD-1 inhibitor pucotenlimab (HX008) in solid tumors exhibits heterogeneity. This study integrated data from 6 clinical trials (covering gastric/gastroesophageal junction cancer, triple-negative breast cancer, melanoma, and dMMR/MSI-H solid tumors) using Bayesian meta-analysis, machine learning (optimal XGBoost AUC = 0.86), and network meta-analysis to construct an integrated "efficacy-prediction-safety" framework. Bayesian analysis showed pucotenlimab significantly improved outcomes versus control (ORR OR = 4.82, 95% CrI: 3.65-6.38; PFS HR = 0.41, 0.32-0.52; OS HR = 0.37, 0.26-0.51). Subgroups revealed TNBC patients with gemcitabine/cisplatin achieved highest ORR (80.6%, 62.5%-92.6%), while mucosal melanoma showed lowest response (8.7%, 1.1%-28.0%). Combination therapy demonstrated superior efficacy to monotherapy (ORR OR: 5.91 vs. 2.35). Machine learning identified 4 efficacy biomarkers (KMT2D mutation, post-treatment NLR decrease, PD-L1 CPS ≥ 1, high eotaxin) and 3 irAE risk factors (baseline NLR ≥ 4, irinotecan combination, high VEGF). Network analysis recommended regimens: gemcitabine/cisplatin for TNBC (SUCRA = 95.7%), oxaliplatin/capecitabine for G/GEJ cancer (ORR = 60.0% vs. irinotecan 27.6%, HR = 0.45). The integrated model classified high-benefit (≥ 3 points; ORR 78.2%) and low-benefit (≤ 0 points; ORR 28.3%) groups, plus high-risk (≤ -2 points; grade ≥ 3 irAEs 41.2%) and low-risk (≥ 1 point; irAEs 3.5%) groups, validated by decision curve analysis. This defines precise application scenarios and provides an extensible analytical paradigm.