ArticleThe Lancet regional health. Western Pacific2023
Efficacy, safety, and correlative biomarkers of bintrafusp alfa in recurrent or metastatic nasopharyngeal cancer patients: a phase II clinical trial.
Article in The Lancet regional health. Western Pacific, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.
- PD-L1 expression as a potential predictor of immune checkpoint inhibitor efficacy and survival in patients with recurrent or metastatic nasopharyngeal cancer: a systematic review and meta-analysis of prospective trials.Frontiers in oncology · 2024Pooled it
- Blockade of Tumor-Intrinsic TGFβ Signaling Drives Hyperprogression in Small Cell Lung Cancer.Cancer discovery · 2026Article
- Cancer-Associated Fibroblasts Functions as Multifunctional Architects of the Tumor Stroma and Represent Emerging Therapeutic Vulnerabilities.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- A Bioimaging Study ofMolecular imaging and biology · 2026Article
- Immune-excluded and immune-suppressive tumor microenvironments: mechanisms, spatial biomarkers, and therapeutic rewiring.Frontiers in oncology · 2026Review
- Pre-existing CD95-based Temra immunity in patients with recurrent/metastatic nasopharyngeal carcinoma predicts response and hyperprogression to dual PD-L1 and TGFβ inhibition.Clinical and translational medicine · 2025Article
- [Research Progress on the Potential Mechanisms of Hyper-progressive Disease in Immune Checkpoint Blockade Therapy of Solid Tumors].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025Review
- Article
- Microbiome meets immunotherapy: unlocking the hidden predictors of immune checkpoint inhibitors.NPJ biofilms and microbiomes · 2025Article
- Novel Therapeutic Development for Nasopharyngeal Carcinoma.Current oncology (Toronto, Ont.) · 2025Review
- TGFB2 mRNA Levels Prognostically Interact with Interferon-Alpha Receptor Activation of IRF9 and IFI27, and an Immune Checkpoint LGALS9 to Impact Overall Survival in Pancreatic Ductal Adenocarcinoma.International journal of molecular sciences · 2024Article
- Review
- Long-term outcomes of induction chemotherapy followed by concurrent chemoradiotherapy and adjuvant chemotherapy for locoregionally advanced nasopharyngeal carcinoma: a retrospective study.Frontiers in oncology · 2024Review
- PD-1 inhibitors combined with chemotherapy versus chemotherapy alone: efficacy and prognostic analysis in recurrent metastatic nasopharyngeal carcinoma.American journal of translational research · 2024Article
Corrections and comments
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Authors and funding
20 authors at 6 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: The strategy of dual blockade of TGF-β and PD-L1 pathways has not been previously tested in platinum-refractory recurrent or metastatic nasopharyngeal cancer (R/M NPC) patients. This study aimed to evaluate the safety and efficacy of bintrafusp alfa in refractory R/M NPC patients. Methods: In this single-arm, single-centre phase II clinical trial, 38 histologically confirmed R/M NPC patients were enrolled and administered with bintrafusp alfa every 2 weeks. Primary endpoint was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. Findings: Thirty-eight patients were accrued (33 men; median age, 54 years). ORR was 23.7% (complete response, n = 2; partial response, n = 7). The median DOR was 19.2 months, median PFS was 2.3 months, median OS was 17.0 months, and 1-year OS rate was 63.2%. Unfortunately, 25 patients (65.7%) progressed within 8 weeks of treatment, 15 patients (39.5%) and 8 patients (21.1%) developed hyper-progressive disease (HPD) per RECIST v1.1 and tumor growth rate (TGR) ratio respectively. Sixteen patients (42.4%) experienced ≥ grade 3 treatment-related adverse events (TRAEs), most commonly anemia (n = 9, 23.7%) and secondary malignancies (n = 4, 10.5%). TRAEs led to permanent treatment discontinuation in 7 patients. Patients with strong suppression of plasma TGFβ1 level at week 8 were unexpectedly associated with worse ORR (9.1% vs 44.4%, Interpretation: Bintrafusp alfa demonstrated modest activity in R/M NPC but high rates of HPD and treatment discontinuation secondary to TRAEs are concerning. Funding: The project was supported by Alice Ho Miu Ling Nethersole Charity Foundation Professorship Endowed Fund and Merck KGaA.
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