A phase 2 study of spartalizumab (PDR001) among patients with recurrent or metastatic esophageal squamous cell carcinoma (KCSG HN18-17, K-MASTER project 12)

References

• Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: globocan estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–12. doi:10.3322/caac.21660. PMID: 33538338.
   PubMed Web of Science ®Google Scholar
• Abnet CC, Arnold M, Wei WQ. Epidemiology of esophageal squamous cell carcinoma. Gastroenterology. 2018;154(2):360–373. doi:10.1053/j.gastro.2017.08.023. PMID: 28823862.
   PubMed Web of Science ®Google Scholar
• van Hagen P, Hulshof MC, van Lanschot Jj, Steyerberg EW, van Berge Henegouwen Mi, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ. et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012;366(22):2074–2084. doi:10.1056/NEJMoa1112088. PMID: 22646630.
   PubMed Web of Science ®Google Scholar
• Liu S, Wen J, Yang H, Li Q, Chen Y, Zhu C, Fang W, Yu Z, Mao W, Xiang J. et al. Recurrence patterns after neoadjuvant chemoradiotherapy compared with surgery alone in oesophageal squamous cell carcinoma: results from the multicenter phase III trial NEOCRTEC5010. Eur J Cancer. 2020;138:113–121. doi:10.1016/j.ejca.2020.08.002. PMID: 32877795.
   PubMed Web of Science ®Google Scholar
• Raufi AG, Klempner SJ. Immunotherapy for advanced gastric and esophageal cancer: preclinical rationale and ongoing clinical investigations. J Gastrointest Oncol. 2015;6(5):561–569. doi:10.3978/j.issn.2078-6891.2015.037. PMID: 26487950.
   PubMed Web of Science ®Google Scholar
• Thuss-Patience P, Stein A. Immunotherapy in squamous cell cancer of the esophagus. Curr Oncol. 2022;29:2461–2471. doi:10.3390/curroncol29040200. PMID: 35448174.
   PubMed Web of Science ®Google Scholar
• Keir ME, Butte MJ, Freeman GJ, Sharpe AH. PD-1 and its ligands in tolerance and immunity. Annu Rev Immunol. 2008;26(1):677–704. doi:10.1146/annurev.immunol.26.021607.090331. PMID: 18173375.
   PubMed Web of Science ®Google Scholar
• Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer. 2012;12(4):252–264. doi:10.1038/nrc3239. PMID: 22437870.
   PubMed Web of Science ®Google Scholar
• Freeman GJ, Long AJ, Iwai Y, Bourque K, Chernova T, Nishimura H, Fitz LJ, Malenkovich N, Okazaki T, Byrne MC. et al. Engagement of the PD-1 immunoinhibitory receptor by a novel B7 family member leads to negative regulation of lymphocyte activation. J Exp Med. 2000;192(7):1027–1034. doi:10.1084/jem.192.7.1027. PMID: 11015443.
   PubMed Web of Science ®Google Scholar
• Latchman Y, Wood CR, Chernova T, Chaudhary D, Borde M, Chernova I, Iwai Y, Long AJ, Brown JA, Nunes R. et al. PD-L2 is a second ligand for PD-1 and inhibits T cell activation. Nat Immunol. 2001;2(3):261–268. doi:10.1038/85330. PMID: 11224527.
   PubMed Web of Science ®Google Scholar
• Wong RM, Scotland RR, Lau RL, Wang C, Korman AJ, Kast WM, Weber JS. Programmed death-1 blockade enhances expansion and functional capacity of human melanoma antigen-specific CTLs. Int Immunol. 2007;19(10):1223–1234. doi:10.1093/intimm/dxm091. PMID: 17898045.
   PubMed Web of Science ®Google Scholar
• Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E. et al. Nivolumab versus docetaxel in advanced nonsquamous non–small-cell lung cancer. N Engl J Med. 2015;373(17):1627–1639. doi:10.1056/NEJMoa1507643. PMID: 26412456.
   PubMed Web of Science ®Google Scholar
• Robert C, Schachter J, Long GV, Arance A, Grob JJ, Mortier L, Daud A, Carlino MS, McNeil C, Lotem M. et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med. 2015;372(26):2521–2532. doi:10.1056/NEJMoa1503093. PMID: 25891173.
   PubMed Web of Science ®Google Scholar
• Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF. et al. Pembrolizumab plus chemotherapy in metastatic non–small-cell lung cancer. N Engl J Med. 2018;378(22):2078–2092. doi:10.1056/NEJMoa1801005. PMID: 29658856.
   PubMed Web of Science ®Google Scholar
• Borghaei H, O’Byrne KJ, Paz-Ares L, Ciuleanu TE, Yu X, Pluzanski A, Nagrial A, Havel L, Kowalyszyn RD, Valette CA. et al. Nivolumab plus chemotherapy in first-line metastatic non-small-cell lung cancer: results of the phase III CheckMate 227 Part 2 trial. ESMO Open. 2023;8(6):102065. doi:10.1016/j.esmoop.2023.102065. PMID: 37988950.
   PubMed Web of Science ®Google Scholar
• Burtness B, Harrington KJ, Greil R, Soulières D, Tahara M, de Castro G Jr., Psyrri A, Basté N, Neupane P, Bratland Å. et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet. 2019;394(10212):1915–1928. doi:10.1016/s0140-6736(19)32591-7. PMID: 31679945.
   PubMed Web of Science ®Google Scholar
• Sun JM, Shen L, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB. et al. Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study. Lancet. 2021;398(10302):759–771. doi:10.1016/s0140-6736(21)01234-4. PMID: 34454674.
   PubMed Web of Science ®Google Scholar
• Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A. et al. Nivolumab combination therapy in advanced esophageal squamous-cell carcinoma. N Engl J Med. 2022;386(5):449–462. doi:10.1056/NEJMoa2111380. PMID: 35108470.
   PubMed Web of Science ®Google Scholar
• Naing A, Gainor JF, Gelderblom H, Forde PM, Butler MO, Lin CC, Sharma S, Ochoa de Olza M, Varga A, Taylor M. et al. A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti–PD-1 antibody, in patients with advanced solid tumors. J Immunother Cancer. 2020;8(1):e000530. doi:10.1136/jitc-2020-000530. PMID: 32179633.
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M. et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247. doi:10.1016/j.ejca.2008.10.026. PMID: 19097774.
   PubMed Web of Science ®Google Scholar
• Park KH, Choi JY, Lim AR, Kim JW, Choi YJ, Lee S, Sung JS, Chung HJ, Jang B, Yoon D. et al. Genomic landscape and clinical utility in Korean advanced pan-cancer patients from prospective clinical sequencing: K-MASTER program. Cancer Discov. 2022;12(4):938–948. doi:10.1158/2159-8290.Cd-21-1064. PMID: 34862196.
   PubMed Web of Science ®Google Scholar
• Gavrielatou N, Fortis E, Spathis A, Anastasiou M, Economopoulou P, Foukas GRP, Lelegiannis IM, Rusakiewicz S, Vathiotis I, Aung TN. et al. B-cell infiltration is associated with survival outcomes following programmed cell death protein 1 inhibition in head and neck squamous cell carcinoma. Ann Oncol. 2024;35(4):340–350. doi:10.1016/j.annonc.2023.12.011. PMID: 38159908.
   PubMed Web of Science ®Google Scholar
• Noble F, Mellows T, McCormick Matthews LH, Bateman AC, Harris S, Underwood TJ, Byrne JP, Bailey IS, Sharland DM, Kelly JJ. et al. Tumour infiltrating lymphocytes correlate with improved survival in patients with oesophageal adenocarcinoma. Cancer Immunol Immunother. 2016;65(6):651–662. doi:10.1007/s00262-016-1826-5. PMID: 27020682.
   PubMed Web of Science ®Google Scholar
• Chen K, Zhu Z, Zhang N, Cheng G, Zhang F, Jin J, Wu J, Ying L, Mao W, Su D. Tumor-Infiltrating CD4+ lymphocytes predict a favorable survival in patients with operable esophageal squamous cell carcinoma. Med Sci Monit. 2017;23:4619–4632. doi:10.12659/msm.904154. PMID: 28949934.
   PubMed Web of Science ®Google Scholar
• Lee J, Kim B, Jung HA, La Choi Y, Sun JM. Nivolumab for esophageal squamous cell carcinoma and the predictive role of PD-L1 or CD8 expression in its therapeutic effect. Cancer Immunol Immunother. 2021;70(5):1203–1211. doi:10.1007/s00262-020-02766-7. PMID: 33123755.
   PubMed Web of Science ®Google Scholar
• Guo JC, Hsu CL, Huang YL, Lin CC, Huang TC, Wu IC, Lin CY, Lien MY, Kuo HY, Cheng AL. et al. B cells in tumor microenvironment associated with the clinical benefit to programmed cell death protein-1 blockade therapy in patients with advanced esophageal squamous cell carcinoma. Front Oncol. 2022;12:879398. doi:10.3389/fonc.2022.879398. PMID: 35847892.
   PubMed Web of Science ®Google Scholar
• Helmink BA, Reddy SM, Gao J, Zhang S, Basar R, Thakur R, Yizhak K, Sade-Feldman M, Blando J, Han G. et al. B cells and tertiary lymphoid structures promote immunotherapy response. Nature. 2020;577(7791):549–555. doi:10.1038/s41586-019-1922-8. PMID: 31942075.
   PubMed Web of Science ®Google Scholar
• Zhang C, Hao X. Prognostic significance of CD276 in non-small cell lung cancer. Open Med (Wars). 2019;14(1):805–812. doi:10.1515/med-2019-0076. PMID: 31737785.
   PubMedGoogle Scholar
• Li F, Chen H, Wang D. Silencing of CD276 suppresses lung cancer progression by regulating integrin signaling. J Thorac Dis. 2020;12(5):2137–2145. doi:10.21037/jtd.2020.04.41. PMID: 32642118.
   PubMed Web of Science ®Google Scholar
• Lee BR, Chae S, Moon J, Kim MJ, Lee H, Ko HW, Cho BC, Shim HS, Hwang D, Kim HR. et al. Combination of PD-L1 and PVR determines sensitivity to PD-1 blockade. JCI Insight. 2020;5(14). doi:10.1172/jci.insight.128633. PMID: 32554931.
   Web of Science ®Google Scholar
• Liu WF, Quan B, Li M, Zhang F, Hu KS, Yin X. PVR—A prognostic biomarker correlated with immune cell infiltration in hepatocellular Carcinoma. Diagn (Basel). 2022;12(12):2953. doi:10.3390/diagnostics12122953. PMID: 36552960.
   PubMedGoogle Scholar
• Daud AI, Loo K, Pauli ML, Sanchez-Rodriguez R, Sandoval PM, Taravati K, Tsai K, Nosrati A, Nardo L, Alvarado MD. et al. Tumor immune profiling predicts response to anti–PD-1 therapy in human melanoma. J Clin Invest. 2016;126(9):3447–3452. doi:10.1172/jci87324. PMID: 27525433.
   PubMed Web of Science ®Google Scholar
• Yang L, Zhao Q, Wang X, Pilapong C, Li Y, Zou J, Jin J, Rong J. Investigation on the regulatory T cells signature and relevant Foxp3/STAT3 axis in esophageal cancer. Cancer Med. 2022;12(4):4993–5008. doi:10.1002/cam4.5194. PMID: 36226375.
   PubMed Web of Science ®Google Scholar
• Jesinghaus M, Steiger K, Slotta-Huspenina J, Drecoll E, Pfarr N, Meyer P, Konukiewitz B, Bettstetter M, Wieczorek K, Ott K. et al. Increased intraepithelial CD3+ T-lymphocytes and high PD-L1 expression on tumor cells are associated with a favorable prognosis in esophageal squamous cell carcinoma and allow prognostic immunogenic subgrouping. Oncotarget. 2017;8(29):46756–46768. doi:10.18632/oncotarget.18606. PMID: 28657901.
   PubMedGoogle Scholar
• Yang J, Liu X, Cao S, Dong X, Rao S, Cai K. Understanding esophageal cancer: The challenges and opportunities for the next decade. Front Oncol. 2020;10:1727. doi:10.3389/fonc.2020.01727. PMID: 33014854.
   PubMed Web of Science ®Google Scholar
• Kudo T, Hamamoto Y, Kato K, Ura T, Kojima T, Tsushima T, Hironaka S, Hara H, Satoh T, Iwasa S. et al. Nivolumab treatment for oesophageal squamous-cell carcinoma: an open-label, multicentre, phase 2 trial. Lancet Oncol. 2017;18(5):631–639. doi:10.1016/s1470-2045(17)30181-x. PMID: 28314688.
   PubMed Web of Science ®Google Scholar
• Shah MA, Kojima T, Hochhauser D, Enzinger P, Raimbourg J, Hollebecque A, Lordick F, Kim SB, Tajika M, Kim HT. et al. Efficacy and safety of pembrolizumab for heavily pretreated patients with advanced, metastatic adenocarcinoma or squamous cell carcinoma of the esophagus: The phase 2 KEYNOTE-180 study. JAMA Oncol. 2019;5(4):546–550. doi:10.1001/jamaoncol.2018.5441. PMID: 30570649.
   PubMed Web of Science ®Google Scholar
• Kato K, Cho BC, Takahashi M, Okada M, Lin CY, Chin K, Kadowaki S, Ahn MJ, Hamamoto Y, Doki Y. et al. Nivolumab versus chemotherapy in patients with advanced oesophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(11):1506–1517. doi:10.1016/s1470-2045(19)30626-6. PMID: 31582355.
   PubMed Web of Science ®Google Scholar
• Kojima T, Shah MA, Muro K, Francois E, Adenis A, Hsu CH, Doi T, Moriwaki T, Kim SB, Lee SH. et al. Randomized phase III KEYNOTE-181 study of pembrolizumab versus chemotherapy in advanced esophageal cancer. J Clin Oncol. 2020;38(35):4138–4148. doi:10.1200/jco.20.01888. PMID: 33026938.
   PubMed Web of Science ®Google Scholar
• Kato K, Kojima T, Hochhauser D, Bennouna J, Hollebecque A, Lordick F, Kim S-B, Tajika M, Kim HT, Park H. et al. Pembrolizumab in previously treated metastatic esophageal cancer: Longer term follow-up from the phase 2 KEYNOTE-180 study. J Clin Oncol. 2019;37:4032–4032. doi:10.1200/JCO.2019.37.15_suppl.4032.
   Google Scholar
• Satoh T, Kato K, Ura T, Hamamoto Y, Kojima T, Tsushima T, Hironaka S, Hara H, Iwasa S, Muro K. et al. Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07). Esophagus. 2021;18(4):835–843. doi:10.1007/s10388-021-00850-0. PMID: 33993388.
   PubMed Web of Science ®Google Scholar
• Gibson AJW, Li H, D’Silva A, Tudor RA, Elegbede AA, Otsuka S, Bebb DG, Cheung WY. Comparison of clinical characteristics and outcomes in relapsed versus de novo metastatic non–small cell lung cancer. Am J Clin Oncol. 2019;42(1):75–81. doi:10.1097/coc.0000000000000483. PMID: 30211724.
   PubMed Web of Science ®Google Scholar
• Moore S, Leung B, Wu J, Ho C. Survival Implications of De novo versus recurrent metastatic non–small cell lung cancer. Am J Clin Oncol. 2019;42(3):292–297. doi:10.1097/coc.0000000000000513. PMID: 30608237.
   PubMed Web of Science ®Google Scholar
• Miotke L, Nevala-Plagemann C, Ying J, Florou V, Haaland B, Garrido-Laguna I. Treatment outcomes in recurrent versus de novo metastatic pancreatic adenocarcinoma: a real world study. BMC Cancer. 2022;22(1):1054. doi:10.1186/s12885-022-10130-4. PMID: 36224524.
   PubMed Web of Science ®Google Scholar
• Capdevila J, Wirth LJ, Ernst T, Ponce Aix S, Lin CC, Ramlau R, Butler MO, Delord JP, Gelderblom H, Ascierto PA. et al. PD-1 Blockade in Anaplastic Thyroid Carcinoma. J Clin Oncol. 2020;38:2620–2627. doi:10.1200/jco.19.02727. PMID: 32364844.
   PubMed Web of Science ®Google Scholar
• Even C, Wang HM, Li SH, Ngan RK, Dechaphunkul A, Zhang L, Yen CJ, Chan PC, Chakrabandhu S, Ma BBY. et al. Phase II, Randomized Study of Spartalizumab (PDR001), an Anti–PD-1 Antibody, versus Chemotherapy in Patients with Recurrent/Metastatic Nasopharyngeal Cancer. Clin Cancer Res. 2021;27(23):6413–6423. doi:10.1158/1078-0432.Ccr-21-0822. PMID: 34433653.
   PubMed Web of Science ®Google Scholar
• Minami H, Doi T, Toyoda M, Imamura Y, Kiyota N, Mitsuma A, Shimokata T, Naito Y, Matsubara N, Tajima T. et al. Phase I study of the antiprogrammed cell death-1 Ab spartalizumab (PDR001) in Japanese patients with advanced malignancies. Cancer Sci. 2021;112(2):725–733. doi:10.1111/cas.14678. PMID: 33031626.
   PubMed Web of Science ®Google Scholar
• Yao JC, Strosberg J, Fazio N, Pavel ME, Bergsland E, Ruszniewski P, Halperin DM, Li D, Tafuto S, Raj N. et al. Spartalizumab in metastatic, well/poorly-differentiated neuroendocrine neoplasms. Endocr Relat Cancer. 2021;28(3):161–172. doi:10.1530/erc-20-0382. PMID: 33480358.
   Web of Science ®Google Scholar
• Schöffski P, Tan DSW, Martín M, Ochoa-de-Olza M, Sarantopoulos J, Carvajal RD, Kyi C, Esaki T, Prawira A, Akerley W. et al. Phase I/II study of the LAG-3 inhibitor ieramilimab (LAG525) ± anti-PD-1 spartalizumab (PDR001) in patients with advanced malignancies. J Immunother Cancer. 2022;10(2):e003776. doi:10.1136/jitc-2021-003776. PMID: 35217575.
   PubMed Web of Science ®Google Scholar
• Lin C-C, Garralda E, Schöffski P, Hong DS, Siu LL, Martin M, Maur M, Hui R, Soo RA, Chiu J. A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies. OncoImmunology. 2024;13(1):2290787. doi:10.1080/2162402X.2023.2290787.
   PubMed Web of Science ®Google Scholar
• Zhou YX, Chen P, Sun YT, Zhang B, Qiu MZ. Comparison of PD-1 Inhibitors in patients with advanced esophageal squamous cell carcinoma in the second-line setting. Front Oncol. 2021;11:698732. doi:10.3389/fonc.2021.698732. PMID: 34621668.
   PubMedGoogle Scholar
• Baba Y, Nomoto D, Okadome K, Ishimoto T, Iwatsuki M, Miyamoto Y, Yoshida N, Baba H. Tumor immune microenvironment and immune checkpoint inhibitors in esophageal squamous cell carcinoma. Cancer Sci. 2020;111(9):3132–3141. doi:10.1111/cas.14541. PMID: 32579769.
   PubMed Web of Science ®Google Scholar
• Laumont CM, Banville AC, Gilardi M, Hollern DP, Nelson BH. Tumour-infiltrating B cells: immunological mechanisms, clinical impact and therapeutic opportunities. Nat Rev Cancer. 2022;22(7):414–430. doi:10.1038/s41568-022-00466-1. PMID: 35393541.
   PubMed Web of Science ®Google Scholar
• Giraldo NA, Sanchez-Salas R, Peske JD, Vano Y, Becht E, Petitprez F, Validire P, Ingels A, Cathelineau X, Fridman WH. et al. The clinical role of the TME in solid cancer. Br J Cancer. 2019;120(1):45–53. doi:10.1038/s41416-018-0327-z. PMID: 30413828.
   PubMed Web of Science ®Google Scholar
• Wang J, Gong R, Zhao C, Lei K, Sun X, Ren H. Human FOXP3 and tumour microenvironment. Immunology. 2023;168(2):248–255. doi:10.1111/imm.13520. PMID: 35689826.
   PubMed Web of Science ®Google Scholar
• Hu Q, Hong Y, Qi P, Lu G, Mai X, Xu S, He X, Guo Y, Gao L, Jing Z. et al. Atlas of breast cancer infiltrated B-lymphocytes revealed by paired single-cell RNA-sequencing and antigen receptor profiling. Nat Commun. 2021;12(1):2186. doi:10.1038/s41467-021-22300-2. PMID: 33846305.
   PubMed Web of Science ®Google Scholar
• Liu S, Liang J, Liu Z, Zhang C, Wang Y, Watson AH, Zhou C, Zhang F, Wu K, Zhang F. et al. The Role of CD276 in Cancers. Front Oncol. 2021;11:654684. doi:10.3389/fonc.2021.654684. PMID: 33842369.
   PubMedGoogle Scholar
• Kontos F, Michelakos T, Kurokawa T, Sadagopan A, Schwab JH, Ferrone CR, Ferrone S. B7-H3: An Attractive Target for Antibody-based Immunotherapy. Clin Cancer Res. 2021;27(5):1227–1235. doi:10.1158/1078-0432.Ccr-20-2584. PMID: 33051306.
   PubMed Web of Science ®Google Scholar
• Sun Y, Wang Y, Zhao J, Gu M, Giscombe R, Lefvert AK, Wang X. B7-H3 and B7-H4 expression in non-small-cell lung cancer. Lung Cancer. 2006;53(2):143–151. doi:10.1016/j.lungcan.2006.05.012. PMID: 16782226.
   PubMed Web of Science ®Google Scholar
• Katayama A, Takahara M, Kishibe K, Nagato T, Kunibe I, Katada A, Hayashi T, Harabuchi Y. Expression of B7-H3 in hypopharyngeal squamous cell carcinoma as a predictive indicator for tumor metastasis and prognosis. Int J Oncol. 2011;38(5):1219–1226. doi:10.3892/ijo.2011.949. PMID: 21344157.
   PubMed Web of Science ®Google Scholar
• Feustel K, Martin J, Falchook GS. B7-H3 Inhibitors in Oncology Clinical Trials: A Review. J Immunother Precis Oncol. 2024;7(1):53–66. doi:10.36401/jipo-23-18. PMID: 38327753.
   PubMedGoogle Scholar
• Aggarwal C, Prawira A, Antonia S, Rahma O, Tolcher A, Cohen RB, Lou Y, Hauke R, Vogelzang N, Pz D. et al. Dual checkpoint targeting of B7-H3 and PD-1 with enoblituzumab and pembrolizumab in advanced solid tumors: interim results from a multicenter phase I/II trial. J Immunother Cancer. 2022;10(4):e004424. doi:10.1136/jitc-2021-004424. PMID: 35414591.
   PubMed Web of Science ®Google Scholar
• Modak S, Zanzonico P, Grkovski M, Slotkin EK, Carrasquillo JA, Lyashchenko SK, Lewis JS, Cheung IY, Heaton T, LaQuaglia MP. et al. B7H3-Directed Intraperitoneal Radioimmunotherapy with Radioiodinated Omburtamab for desmoplastic small round cell tumor and other peritoneal tumors: Results of a phase I study. J Clin Oncol. 2020;38:4283–4291. doi:10.1200/jco.20.01974. PMID: 33119478.
   PubMed Web of Science ®Google Scholar
• Anagnostou V, Yarchoan M, Hansen AR, Wang H, Verde F, Sharon E, Collyar D, Chow LQM, Forde PM. Immuno-oncology trial endpoints: capturing clinically meaningful activity. Clin Cancer Res. 2017;23(17):4959–4969. doi:10.1158/1078-0432.Ccr-16-3065. PMID: 28864724.
   PubMed Web of Science ®Google Scholar
• Reiter JG, Makohon-Moore AP, Gerold JM, Heyde A, Attiyeh MA, Kohutek ZA, Tokheim CJ, Brown A, DeBlasio RM, Niyazov J. et al. Minimal functional driver gene heterogeneity among untreated metastases. Science. 2018;361(6406):1033–1037. doi:10.1126/science.aat7171. PMID: 30190408.
   PubMed Web of Science ®Google Scholar
• Balmain A. The critical roles of somatic mutations and environmental tumor-promoting agents in cancer risk. Nat Genet. 2020;52(11):1139–1143. doi:10.1038/s41588-020-00727-5. PMID: 33106632.
   PubMed Web of Science ®Google Scholar
• Twomey JD, Zhang B. Cancer Immunotherapy Update: FDA-Approved checkpoint inhibitors and companion diagnostics. Aaps J. 2021;23(2):39. doi:10.1208/s12248-021-00574-0. PMID: 33677681.
   PubMed Web of Science ®Google Scholar
• Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A. et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N Engl J Med. 2021;384(13):1191–1203. doi:10.1056/NEJMoa2032125. PMID: 33789008.
   PubMed Web of Science ®Google Scholar
• Ayers M, Lunceford J, Nebozhyn M, Murphy E, Loboda A, Kaufman DR, Albright A, Cheng JD, Kang SP, Shankaran V. et al. IFN-γ–related mRNA profile predicts clinical response to PD-1 blockade. J Clin Invest. 2017;127(8):2930–2940. doi:10.1172/jci91190. PMID: 28650338.
   PubMed Web of Science ®Google Scholar