Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A et al (2021) Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71(3):209–249
Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D’Amico TA, DeCamp M (2022) Non–small cell lung cancer, version 3.2022, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw 20(5):497–530
Garon EB, Hellmann MD, Rizvi NA, Carcereny E, Leighl NB, Ahn MJ et al (2019) Five-year overall survival for patients with advanced non-small-cell lung cancer treated with pembrolizumab: results from the phase I KEYNOTE-001 study. J Clin Oncol 37(28):2518–2527
Article CAS PubMed PubMed Central Google Scholar
Boyero L, Sánchez-Gastaldo A, Alonso M, Noguera-Uclés JF, Molina-Pinelo S, Bernabé-Caro R (2020) Primary and acquired resistance to immunotherapy in lung cancer: unveiling the mechanisms underlying of immune checkpoint blockade therapy. Cancers (Basel). https://doi.org/10.3390/cancers12123729
Article PubMed PubMed Central Google Scholar
Wang F, Wang S, Zhou Q (2020) The resistance mechanisms of lung cancer immunotherapy. Front Oncol 10:568059
Article PubMed PubMed Central Google Scholar
Nadler E, Arondekar B, Aguilar KM, Zhou J, Chang J, Zhang X et al (2021) Treatment patterns and clinical outcomes in patients with advanced non-small cell lung cancer initiating first-line treatment in the US community oncology setting: a real-world retrospective observational study. J Cancer Res Clin Oncol 147(3):671–690
Gulley JL, Schlom J, Barcellos-Hoff MH, Wang XJ, Seoane J, Audhuy F et al (2022) Dual inhibition of TGF-beta and PD-L1: a novel approach to cancer treatment. Mol Oncol 16(11):2117–2134
Article CAS PubMed PubMed Central Google Scholar
Lan Y, Zhang D, Xu C, Hance KW, Marelli B, Qi J et al (2018) Enhanced preclinical antitumor activity of M7824, a bifunctional fusion protein simultaneously targeting PD-L1 and TGF-β. Sci Transl Med 10(424):eaan5488
David JM, Dominguez C, McCampbell KK, Gulley JL, Schlom J, Palena C (2017) A novel bifunctional anti-PD-L1/TGF-β trap fusion protein (M7824) efficiently reverts mesenchymalization of human lung cancer cells. Oncoimmunology 6(10):e1349589
Article PubMed PubMed Central Google Scholar
Cho BC, Lee JS, Wu YL, Cicin I, Dols MC, Ahn MJ et al (2023) Bintrafusp alfa versus pembrolizumab in patients with treatment-naive, programmed death-ligand 1-high advanced nsclc: a randomized, open-label, phase 3 trial. J Thorac Oncol 18(12):1731–1742
Article CAS PubMed Google Scholar
Barlesi F, Isambert N, Felip E, Cho BC, Lee DH, Peguero J et al (2023) Bintrafusp alfa, a bifunctional fusion protein targeting tgf-beta and pd-l1, in patients with non-small cell lung cancer resistant or refractory to immune checkpoint inhibitors. Oncologist 28(3):258–267
Article PubMed PubMed Central Google Scholar
Paz-Ares L, Kim TM, Vicente D, Felip E, Lee DH, Lee KH et al (2020) Bintrafusp alfa, a bifunctional fusion protein targeting tgf-beta and pd-l1, in second-line treatment of patients with nsclc: results from an expansion cohort of a phase 1 trial. J Thorac Oncol: Offl Publicat Intl Associ Stud Lung Canc 15(7):1210–1222
Vokes EE, Mornex F, Sezer A, Cheng Y, Fang J, Baz DV et al (2024) Bintrafusp alfa with CCRT followed by bintrafusp alfa versus placebo with CCRT followed by durvalumab in patients with unresectable stage III NSCLC: a phase 2 randomized study. J Thorac Oncol 19(2):285–296
Article CAS PubMed Google Scholar
Chiang CL, Lam TC, Li JCB, Chan KSK, El Helali A, Lee YYP et al (2023) Efficacy, safety, and correlative biomarkers of bintrafusp alfa in recurrent or metastatic nasopharyngeal cancer patients: a phase II clinical trial. The Lancet Regional Health 40:100898
PubMed PubMed Central Google Scholar
Cho BC, Daste A, Ravaud A, Salas S, Isambert N, McClay E et al (2020) Bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort. J Immunother Cancer 8(2):07
Kang YK, Bang YJ, Kondo S, Chung HC, Muro K, Dussault I et al (2020) Safety and tolerability of bintrafusp alfa, a bifunctional fusion protein targeting tgfbeta and pd-l1, in asian patients with pretreated recurrent or refractory gastric cancer. Clin Cancer Res 26(13):3202–3210
Article CAS PubMed Google Scholar
Khasraw M, Weller M, Lorente D, Kolibaba K, Lee CK, Gedye C et al (2021) Bintrafusp alfa (M7824), a bifunctional fusion protein targeting TGF-β and PD-L1: results from a phase I expansion cohort in patients with recurrent glioblastoma. Neuro-Oncol Adv 3(1):vdab058
Lin CC, Doi T, Muro K, Hou MM, Esaki T, Hara H, Chung HC, Helwig C, Dussault I, Osada M, Kondo S (2021) Bintrafusp alfa, a bifunctional fusion protein targeting TGFβ and PD-L1, in patients with esophageal squamous cell carcinoma: results from a phase 1 cohort in Asia. Target Oncol 16(4):447–59
Article PubMed PubMed Central Google Scholar
Tan B, Khattak A, Felip E, Kelly K, Rich P, Wang D et al (2021) Bintrafusp alfa, a bifunctional fusion protein targeting tgf-beta and pd-l1, in patients with esophageal adenocarcinoma: results from a phase 1 cohort. Target 16(4):435–446
Morris VK, Overman MJ, Lam M, Parseghian CM, Johnson B, Dasari A et al (2022) Bintrafusp alfa, an anti-PD-L1:TGF-beta trap fusion protein, in patients with ctDNA-positive, liver-limited metastatic colorectal cancer. Cancer Res Commun 2(9):979–986
Article CAS PubMed PubMed Central Google Scholar
Spira A, Wertheim MS, Kim EJ, Tan B, Lenz HJ, Nikolinakos P et al (2023) Bintrafusp alfa: a bifunctional fusion protein targeting pd-l1 and tgf-beta, in patients with pretreated colorectal cancer: results from a phase i trial. Oncologist 28(2):e124–e127
Article PubMed PubMed Central Google Scholar
Oaknin A, Ghamande SA, Kasamatsu Y, Gil-Martin M, Grau-Bejar JF, Garcia-Duran C et al (2024) Phase I trial of first-line Bintrafusp alfa in patients with locally advanced or persistent/recurrent/metastatic cervical cancer. Clin Cancer Res 30(5):975–983
Article PubMed PubMed Central Google Scholar
Yoo C, Javle MM, Verdaguer Mata H, de Braud F, Trojan J, Raoul JL et al (2023) Phase 2 trial of bintrafusp alfa as second-line therapy for patients with locally advanced/metastatic biliary tract cancers. Hepatology 78(3):758–770
Article PubMed PubMed Central Google Scholar
Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S et al (2020) Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer 8(1):05
Doi T, Fujiwara Y, Koyama T, Ikeda M, Helwig C, Watanabe M, Vugmeyster Y, Kudo M (2020) Phase I study of the bifunctional fusion protein bintrafusp alfa in Asian patients with advanced solid tumors, including a hepatocellular carcinoma safety‐assessment cohort. The Oncologist 25(9):e1292–302
Strauss J, Gatti-Mays ME, Cho BC, Hill A, Salas S, McClay E et al (2020) Bintrafusp alfa, a bifunctional fusion protein targeting TGF-beta and PD-L1, in patients with human papillomavirus-associated malignancies. J Immunother Cancer 8(2):12
Eisenhauer EA, Therasse P, Bogaerts B, Schwartz LH, Sargent D, Ford R (2009) New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–47
Article CAS PubMed Google Scholar
Burvenich IJG, Goh YW, Guo N, Gan HK, Rigopoulos A, Cao D et al (2021) Radiolabelling and preclinical characterization of 89Zr-Df-radiolabelled bispecific anti-PD-L1/TGF-βRII fusion protein bintrafusp alfa. Eur J Nucl Med Mol Imaging 48(10):3075–3088
Article CAS PubMed Google Scholar
Oh DY, Ikeda M, Lee CK, Rojas C, Hsu CH, Kim JW et al (2024) Bintrafusp alfa and chemotherapy as first-line treatment in biliary tract cancer: a randomized phase 2/3 trial. Hepatology. https://doi.org/10.1097/HEP.0000000000000965
Article PubMed PubMed Central Google Scholar
Burvenich IJG, Goh YW, Guo N, Gan HK, Rigopoulos A, Cao D et al (2021) Radiolabelling and preclinical characterization of 89Zr-Df-radiolabelled bispecific anti-PD-L1/TGF-betaRII fusion protein bintrafusp alfa. Eur J Nucl Med Mol Imaging 48(10):3075–3088
Article CAS PubMed Google Scholar
Scott AM, Akhurst T, Lee FT, Ciprotti M, Davis ID, Weickhardt AJ et al (2020) First clinical study of a pegylated diabody (124)I-labeled PEG-AVP0458 in patients with tumor-associated glycoprotein 72 positive cancers. Theranostics 10(25):11404–11415
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