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Annual Report 2022

Division of Experimental Therapeutics

Kashiwa: Toshihiko Doi, Kiyotaka Yo, Yoichi Naito, Kohei Shitara, Kenichi Harano, Yasutoshi Kuboki, Shigehiro Koganemaru

Tsukiji: Noboru Yamamoto, Takafumi Koyama, Kan Yonemori, Shunsuke Kondo, Satoru Iwasa, Hirokazu Shoji, Kazuki Sudo, Jun Sato, Yuki Katsuya, Takaaki Mizuno

Introduction

The Department of Experimental Therapeutics supports efforts toward the creation of new drugs and other products from breakthroughs originating from academic institutions by achieving results at the level of basic research. We evaluate and discover excellent research and development proposals and provide integrated management of the program so that basic research outcomes are linked through to clinical research and clinical trials for approval. We have conducted several IITs as applications for approval and have promoted research and development in the field of medicine.

The Team and What We Do

This department plays a key role in new anti-cancer drug development in Japan and other countries in Asia. Our top priority is to conduct the FIH trials, but we also perform phase I trials for solid tumors (i.e., all comers). We joined global phase I trials to accelerate new drug development in Japan. We hold web conferences and teleconferences with EU and US sites and discuss patient enrollment and further developmental strategy. Routine web conferences are also held between the NCC Hospital (Tokyo) and the NCC East hospital (Chiba) every Friday morning, sharing information on adverse events and patient enrollment and referring candidates to each other to accelerate enrollment.

Research Activities

We promote the following activities for the appropriate conducting of research and trials.

Planning clinical trial as IITs for achieving POC of new academic seeds.
Holding explanatory meetings for researchers and office employees on compliance with laws, ordinances and guidelines.

We consider development design with the goal of creating innovative drugs and medical devices, as well as ensuring that research projects based on promising results proceed more rapidly and in greater depth.

List of papers published in 2022

Journal

Kashiwa

1. Udagawa H, Takahashi S, Hirao M, Tahara M, Iwasa S, Sato Y, Hamakawa T, Shitara K, Horinouchi H, Chin K, Masuda N, Suzuki T, Okumura S, Takase T, Nagai R, Yonemori K. Liposomal eribulin for advanced adenoid cystic carcinoma, gastric cancer, esophageal cancer, and small cell lung cancer. Cancer medicine, 12:1269-1278, 2023

2. Goto Y, Yoh K, Kato T, Hosomi Y, Usui K, Fukui T, Hirano K, Tanaka H, Taguri M, Kunitoh H. Observational study to predict the efficacy and optimal duration of nivolumab treatment in patients with previously treated advanced or recurrent non-small cell lung cancer. Japanese journal of clinical oncology, 53:153-160, 2023

3. Doi T, Shitara K, Kojima T, Kuboki Y, Matsubara N, Bando H, Yoh K, Naito Y, Hirai H, Kurokawa Y, Kato T, Morizane C. Phase I study of the irreversible fibroblast growth factor receptor 1-4 inhibitor futibatinib in Japanese patients with advanced solid tumors. Cancer science, 114:574-585, 2023

4. Shitara K, Hirao M, Iwasa S, Oshima T, Komatsu Y, Kawazoe A, Sato Y, Hamakawa T, Yonemori K, Machida N, Yuki S, Suzuki T, Okumura S, Takase T, Semba T, Zimmermann B, Teng A, Yamaguchi K. Phase I Study of the Liposomal Formulation of Eribulin (E7389-LF): Results from the Advanced Gastric Cancer Expansion Cohort. Clinical cancer research, 29:1460-1467, 2023

5. Funasaka C, Naito Y, Kusuhara S, Nakao T, Nakajima H, Kawamoto M, Baba K, Mamishin K, Kondoh C, Harano K, Matsubara N, Hosono A, Sasaki T, Kawasaki T, Mukohara T. Clinical features of CDK4/6 inhibitor-related interstitial lung disease in patients with breast cancer: a case series study. Japanese journal of clinical oncology, 53:105-114, 2023

6. Koganemaru S, Kawai T, Fuchigami H, Maeda N, Koyama K, Kuboki Y, Mukohara T, Doi T, Yasunaga M. Quantitative analysis of drug distribution in heterogeneous tissues using dual-stacking capillary electrophoresis-mass spectrometry. British journal of pharmacology, 180:762-774, 2023

7. Naito Y, Nishida T, Doi T. Current status of and future prospects for the treatment of unresectable or metastatic gastrointestinal stromal tumours. Gastric cancer, 26:339-351, 2023

8. Sugimoto A, Matsumoto S, Udagawa H, Itotani R, Usui Y, Umemura S, Nishino K, Nakachi I, Kuyama S, Daga H, Hara S, Miyamoto S, Kato T, Sakakibara-Konishi J, Tabata E, Nakagawa T, Kawaguchi T, Sakai T, Shibata Y, Izumi H, Nosaki K, Zenke Y, Yoh K, Goto K. A Large-Scale Prospective Concordance Study of Plasma- and Tissue-Based Next-Generation Targeted Sequencing for Advanced Non-Small Cell Lung Cancer (LC-SCRUM-Liquid). Clinical cancer research, 29:1506-1514, 2023

9. Tamiya Y, Matsumoto S, Zenke Y, Yoh K, Ikeda T, Shibata Y, Kato T, Nishino K, Nakamura A, Furuya N, Miyamoto S, Kuyama S, Nomura S, Ikeno T, Udagawa H, Sugiyama E, Nosaki K, Izumi H, Sakai T, Hashimoto N, Goto K. Large-scale clinico-genomic profile of non-small cell lung cancer with KRAS G12C: Results from LC-SCRUM-Asia study. Lung cancer (Amsterdam, Netherlands), 176:103-111, 2023

10. Tanaka Y, Nakai T, Suzuki A, Kagawa Y, Noritake O, Taki T, Hashimoto H, Sakai T, Shibata Y, Izumi H, Nosaki K, Udagawa H, Zenke Y, Matsumoto S, Yoh K, Miyazaki S, Sakamoto N, Sakashita S, Kojima M, Watanbe R, Tsuboi M, Goto K, Ishii G. Clinicopathological significance of peritumoral alveolar macrophages in patients with resected early-stage lung squamous cell carcinoma. Cancer immunology, immunotherapy, 72:2205-2215, 2023

11. Liu T, Bai Y, Lin X, Li W, Wang J, Zhang X, Pan H, Bai C, Bai L, Cheng Y, Zhang J, Zhong H, Ba Y, Hu W, Xu R, Guo W, Qin S, Yang N, Lu J, Shitara K, Lei M, Li M, Bao N, Chen T, Shen L. First-line nivolumab plus chemotherapy vs chemotherapy in patients with advanced gastric, gastroesophageal junction and esophageal adenocarcinoma: CheckMate 649 Chinese subgroup analysis. International journal of cancer, 152:749-760, 2023

12. Yamaguchi K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Lee J, Shimoyama T, Lee KW, Saito K, Kawaguchi Y, Kamio T, Kojima A, Sugihara M, Shitara K. Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial. Journal of clinical oncology, 41:816-825, 2023

13. Shitara K, Kawazoe A, Hirakawa A, Nakanishi Y, Furuki S, Fukuda M, Ueno Y, Raizer J, Arozullah A. Phase 1 trial of zolbetuximab in Japanese patients with CLDN18.2+ gastric or gastroesophageal junction adenocarcinoma. Cancer science, 114:1606-1615, 2023

14. Yoshino T, Taieb J, Kuboki Y, Pfeiffer P, Kumar A, Hochster HS. Trifluridine/tipiracil with or without bevacizumab in metastatic colorectal cancer: results of a systematic review and meta-analysis. Therapeutic advances in medical oncology, 15:17588359221146137, 2023

15. Kubota Y, Kawazoe A, Mishima S, Nakamura Y, Kotani D, Kuboki Y, Bando H, Kojima T, Doi T, Yoshino T, Kuwata T, Shitara K. Comprehensive clinical and molecular characterization of claudin 18.2 expression in advanced gastric or gastroesophageal junction cancer. ESMO open, 8:100762, 2023

16. Kuboki Y, Terazawa T, Masuishi T, Nakamura M, Watanabe J, Ojima H, Makiyama A, Kotaka M, Hara H, Kagawa Y, Sugimoto N, Kawakami H, Takashima A, Kajiwara T, Oki E, Sunakawa Y, Ishihara S, Taniguchi H, Nakajima TE, Morita S, Shirao K, Takenaka N, Ozawa D, Yoshino T. Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial. British journal of cancer, 128:1897-1905, 2023

17. Fujiwara Y, Kuboki Y, Furukawa M, Mizuno N, Hara H, Ioka T, Ueno M, Takahashi Y, Takahashi S, Takeuchi S, Lihou C, Ji T, Tian C, Shimizu T. FIGHT-102: A phase 1 study of pemigatinib in Japanese patients with advanced malignancies. Cancer medicine, 12:10597-10611, 2023

18. Hasegawa H, Shitara K, Takiguchi S, Takiguchi N, Ito S, Kochi M, Horinouchi H, Kinoshita T, Yoshikawa T, Muro K, Nishikawa H, Suna H, Kodera Y. A multicenter, open-label, single-arm phase I trial of neoadjuvant nivolumab monotherapy for resectable gastric cancer. Gastric cancer, 25:619-628, 2022

19. Ohe Y, Yamazaki N, Yamamoto N, Murakami H, Yoh K, Kitano S, Hashimoto H, Murayama A, Nakane S, Gemma A. The real-world safety of atezolizumab as second-line or later treatment in Japanese patients with non-small-cell lung cancer: a post-marketing surveillance study. Japanese journal of clinical oncology, 52:623-632, 2022

20. Shukuya T, Takamochi K, Sakurai H, Yoh K, Hishida T, Tsuboi M, Goto Y, Kudo Y, Ohde Y, Okumura S, Taguri M, Kunitoh H. Efficacy of Adjuvant Chemotherapy With Tegafur-Uracil in Patients With Completely Resected, Node-Negative NSCLC-Real-World Data in the Era of Molecularly Targeted Agents and Immunotherapy. JTO clinical and research reports, 3:100320, 2022

21. Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Sakata T, Yatsuzuka N, Doi T, Kato K. First-line pembrolizumab + chemotherapy in Japanese patients with advanced/metastatic esophageal cancer from KEYNOTE-590. Esophagus, 19:683-692, 2022

22. Kurokawa Y, Honma Y, Sawaki A, Naito Y, Iwagami S, Komatsu Y, Takahashi T, Nishida T, Doi T. Pimitespib in patients with advanced gastrointestinal stromal tumor (CHAPTER-GIST-301): a randomized, double-blind, placebo-controlled phase III trial. Annals of oncology, 33:959-967, 2022

23. Yamaguchi K, Minashi K, Sakai D, Nishina T, Omuro Y, Tsuda M, Iwagami S, Kawakami H, Esaki T, Sugimoto N, Oshima T, Kato K, Amagai K, Hosaka H, Komine K, Yasui H, Negoro Y, Ishido K, Tsushima T, Han S, Shiratori S, Takami T, Shitara K. Phase IIb study of pembrolizumab combined with S-1 + oxaliplatin or S-1 + cisplatin as first-line chemotherapy for gastric cancer. Cancer science, 113:2814-2827, 2022

24. Kojima T, Kato K, Hara H, Takahashi S, Muro K, Nishina T, Wakabayashi M, Nomura S, Sato A, Ohtsu A, Doi T. Phase II study of BKM120 in patients with advanced esophageal squamous cell carcinoma (EPOC1303). Esophagus, 19:702-710, 2022

25. Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer science, 113:2788-2797, 2022

26. Imai M, Nakamura Y, Sunami K, Kage H, Komine K, Koyama T, Amano T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Bando H, Makiyama A, Suzuki T, Hirata M, Kohsaka S, Tsuchihara K, Naito Y, Yoshino T. Expert panel consensus recommendations on the use of circulating tumor DNA assays for patients with advanced solid tumors. Cancer science, 113:3646-3656, 2022

27. Sunami K, Naito Y, Komine K, Amano T, Ennishi D, Imai M, Kage H, Kanai M, Kenmotsu H, Koyama T, Maeda T, Morita S, Sakai D, Kohsaka S, Tsuchihara K, Saigusa Y, Yoshino T. Chronological improvement in precision oncology implementation in Japan. Cancer science, 113:3995-4000, 2022

28. Naito Y, Sunami K, Kage H, Komine K, Amano T, Imai M, Koyama T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Watanabe K, Shirota H, Kinoshita I, Yoshioka M, Mamesaya N, Ito M, Kohsaka S, Saigusa Y, Yamamoto K, Hirata M, Tsuchihara K, Yoshino T. Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. JAMA network open, 5:e2245081, 2022

29. Nishio S, Yonemori K, Usami T, Minobe S, Yunokawa M, Iwata T, Okamoto A, Aoki Y, Itamochi H, Takekuma M, Harano K, Yamamoto K, Maruko T, Ugai H, Tekin C, Colombo N, Fujiwara K, Hasegawa K, Ushijima K. Pembrolizumab plus chemotherapy in Japanese patients with persistent, recurrent or metastatic cervical cancer: Results from KEYNOTE-826. Cancer science, 113:3877-3887, 2022

30. Masuda N, Ono M, Mukohara T, Yasojima H, Shimoi T, Kobayashi K, Harano K, Mizutani M, Tanioka M, Takahashi S, Kogawa T, Suzuki T, Okumura S, Takase T, Nagai R, Semba T, Zhao ZM, Ren M, Yonemori K. Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort. European journal of cancer (Oxford, England : 1990), 168:108-118, 2022

31. Kotani H, Masuda N, Yamashita T, Naito Y, Taira T, Inoue K, Takahashi M, Yonemori K, Toyoizumi S, Mori Y, Nagasawa T, Hori N, Iwata H. Efficacy and safety of talazoparib in Japanese patients with germline BRCA-mutated locally advanced or metastatic breast cancer: results of the phase 1 dose-expansion study. Breast cancer (Tokyo, Japan), 29:1088-1098, 2022

32. Yasui H, Takeno A, Hara H, Imamura H, Akamatsu H, Fujitani K, Nakane M, Kondoh CN, Yukisawa S, Nasu J, Miyata Y, Makiyama A, Ishida H, Yoshida N, Matsumura E, Ishigami M, Sugihara M, Ochiai A, Doi T. Prospective analysis of the expression status of FGFR2 and HER2 in colorectal and gastric cancer populations: DS-Screen Study. International journal of colorectal disease, 37:1393-1402, 2022

33. Modi S, Jacot W, Yamashita T, Sohn J, Vidal M, Tokunaga E, Tsurutani J, Ueno NT, Prat A, Chae YS, Lee KS, Niikura N, Park YH, Xu B, Wang X, Gil-Gil M, Li W, Pierga JY, Im SA, Moore HCF, Rugo HS, Yerushalmi R, Zagouri F, Gombos A, Kim SB, Liu Q, Luo T, Saura C, Schmid P, Sun T, Gambhire D, Yung L, Wang Y, Singh J, Vitazka P, Meinhardt G, Harbeck N, Cameron DA. Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. The New England journal of medicine, 387:9-20, 2022

34. Niguma K, Mamishin K, Naito Y, Nomura S, Wakabayashi M, Kusuhara S, Funasaka C, Nakao T, Fukasawa Y, Kondoh C, Harano K, Kogawa T, Matsubara N, Hosono A, Onishi T, Kawasaki T, Mukohara T. Impact of Older Age and Medico-social Factors on the Decision to Offer Adjuvant Chemotherapy to Patients With Breast Cancer. Anticancer research, 42:3743-3751, 2022

35. Abe Y, Taira N, Kashiwabara K, Tsurutani J, Kitada M, Takahashi M, Kato H, Kikawa Y, Sakata E, Naito Y, Hasegawa Y, Saito T, Iwasa T, Takashima T, Aihara T, Mukai H, Hara F, Shien T, Doihara H, Toyooka S. Association of Genetic Polymorphism with Taxane-induced Peripheral Neuropathy: Sub-analysis of a Randomized Phase II Study to Determine the Optimal Dose of 3-week Cycle Nab-Paclitaxel in Metastatic Breast Cancer Patients. Acta medica Okayama, 76:661-671, 2022

36. Kuboki Y, Shimizu T, Yonemori K, Kojima T, Kondo S, Koganemaru S, Iwasa S, Harano K, Koyama T, Lu V, Zhou X, Niu H, Yanai T, Garcia-Ribas I, Doi T, Yamamoto N. Safety, Tolerability, and Pharmacokinetics of TAK-931, a Cell Division Cycle 7 Inhibitor, in Patients with Advanced Solid Tumors: A Phase I First-in-Human Study. Cancer research communications, 2:1426-1435, 2022

37. Remon J, Lacas B, Herbst R, Reck M, Garon EB, Scagliotti GV, Ramlau R, Hanna N, Vansteenkiste J, Yoh K, Groen HJM, Heymach JV, Mandrekar SJ, Okamoto I, Neal JW, Heist RS, Planchard D, Pignon JP, Besse B. ANtiangiogenic Second-line Lung cancer Meta-Analysis on individual patient data in non-small cell lung cancer: ANSELMA. European journal of cancer (Oxford, England : 1990), 166:112-125, 2022

38. Tamiya Y, Nakai T, Suzuki A, Mimaki S, Tsuchihara K, Sato K, Yoh K, Matsumoto S, Zenke Y, Nosaki K, Izumi H, Shibata Y, Sakai T, Taki T, Miyazaki S, Watanabe R, Sakamoto N, Sakashita S, Kojima M, Hashimoto N, Tsuboi M, Goto K, Ishii G. The impact of tertiary lymphoid structures on clinicopathological, genetic and gene expression characteristics in lung adenocarcinoma. Lung cancer (Amsterdam, Netherlands), 174:125-132, 2022

39. Shitara K, Doi T, Hosaka H, Thuss-Patience P, Santoro A, Longo F, Ozyilkan O, Cicin I, Park D, Zaanan A, Pericay C, Özgüroğlu M, Alsina M, Makris L, Benhadji KA, Ilson DH. Efficacy and safety of trifluridine/tipiracil in older and younger patients with metastatic gastric or gastroesophageal junction cancer: subgroup analysis of a randomized phase 3 study (TAGS). Gastric cancer, 25:586-597, 2022

40. Chida K, Kawazoe A, Suzuki T, Kawazu M, Ueno T, Takenouchi K, Nakamura Y, Kuboki Y, Kotani D, Kojima T, Bando H, Mishima S, Kuwata T, Sakamoto N, Watanabe J, Mano H, Ikeda M, Shitara K, Endo I, Nakatsura T, Yoshino T. Transcriptomic Profiling of MSI-H/dMMR Gastrointestinal Tumors to Identify Determinants of Responsiveness to Anti-PD-1 Therapy. Clinical cancer research, 28:2110-2117, 2022

41. Maron SB, Moya S, Morano F, Emmett MJ, Chou JF, Sabwa S, Walch H, Peterson B, Schrock AB, Zhang L, Janjigian YY, Chalasani S, Ku GY, Disel U, Enzinger P, Uboha N, Kato S, Yoshino T, Shitara K, Nakamura Y, Saeed A, Kasi PM, Chao J, Lee J, Capanu M, Wainberg Z, Petty R, Pietrantonio F, Klempner SJ, Catenacci DVT. Epidermal Growth Factor Receptor Inhibition in Epidermal Growth Factor Receptor-Amplified Gastroesophageal Cancer: Retrospective Global Experience. Journal of clinical oncology, 40:2458-2467, 2022

42. Swain SM, Nishino M, Lancaster LH, Li BT, Nicholson AG, Bartholmai BJ, Naidoo J, Schumacher-Wulf E, Shitara K, Tsurutani J, Conte P, Kato T, Andre F, Powell CA. Multidisciplinary clinical guidance on trastuzumab deruxtecan (T-DXd)-related interstitial lung disease/pneumonitis-Focus on proactive monitoring, diagnosis, and management. Cancer treatment reviews, 106:102378, 2022

43. Myer NM, Shitara K, Chung HC, Lordick F, Kelly RJ, Szabo Z, Cao ZA, Leong S, Ilson DH, Weichert W. Evolution of predictive and prognostic biomarkers in the treatment of advanced gastric cancer. Journal of cancer research and clinical oncology, 148:2023-2043, 2022

44. Shah MA, Shitara K, Lordick F, Bang YJ, Tebbutt NC, Metges JP, Muro K, Lee KW, Shen L, Tjulandin S, Hays JL, Starling N, Xu RH, Sturtz K, Fontaine M, Oh C, Brooks E, Xu B, Li W, Li CJ, Borodyansky L, Van Cutsem E. Randomized, double-blind, placebo-controlled phase 3 study of paclitaxel {plus minus} napabucasin in pretreated advanced gastric or gastroesophageal junction adenocarcinoma. Clinical cancer research, 28:3686-3694, 2022

45. Lee KW, Van Cutsem E, Bang YJ, Fuchs CS, Kudaba I, Garrido M, Chung HC, Lee J, Castro HR, Chao J, Wainberg ZA, Cao ZA, Aurora-Garg D, Kobie J, Cristescu R, Bhagia P, Shah S, Tabernero J, Shitara K, Wyrwicz L. Association of Tumor Mutational Burden with Efficacy of Pembrolizumab±Chemotherapy as First-Line Therapy for Gastric Cancer in the Phase III KEYNOTE-062 Study. Clinical cancer research, 28:3489-3498, 2022

46. Yukami H, Kawazoe A, Lin YT, Koyama S, Fukuoka S, Hara H, Takahashi N, Kojima T, Asayama M, Yoshii T, Bando H, Kotani D, Nakamura Y, Kuboki Y, Mishima S, Wakabayashi M, Kuwata T, Goto M, Higuchi K, Yoshino T, Doi T, Nishikawa H, Shitara K. Updated Efficacy Outcomes of Anti-PD-1 Antibodies plus Multikinase Inhibitors for Patients with Advanced Gastric Cancer with or without Liver Metastases in Clinical Trials. Clinical cancer research, 28:3480-3488, 2022

47. Aoki Y, Kawazoe A, Kubota Y, Chida K, Mishima S, Kotani D, Nakamura Y, Kuboki Y, Bando H, Kojima T, Doi T, Yoshino T, Kuwata T, Shitara K. Characteristics and clinical outcomes of patients with advanced gastric or gastroesophageal cancer treated in and out of randomized clinical trials of first-line immune checkpoint inhibitors. International journal of clinical oncology, 27:1413-1420, 2022

48. Shah MA, Shitara K, Lordick F, Bang YJ, Tebbutt NC, Metges JP, Muro K, Lee KW, Shen L, Tjulandin S, Hays JL, Starling N, Xu RH, Sturtz K, Fontaine M, Oh C, Brooks EM, Xu B, Li W, Li CJ, Borodyansky L, Van Cutsem E. Randomized, Double-Blind, Placebo-Controlled Phase III Study of Paclitaxel ± Napabucasin in Pretreated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma. Clinical cancer research, OF1-OF9, 2022

49. Tabernero J, Shen L, Elimova E, Ku G, Liu T, Shitara K, Lin X, Boyken L, Li H, Grim J, Ajani J. HERIZON-GEA-01: Zanidatamab + chemo ± tislelizumab for 1L treatment of HER2-positive gastroesophageal adenocarcinoma. Future oncology (London, England), 18:3255-3266, 2022

50. Yoon HH, Jin Z, Kour O, Kankeu Fonkoua LA, Shitara K, Gibson MK, Prokop LJ, Moehler M, Kang YK, Shi Q, Ajani JA. Association of PD-L1 Expression and Other Variables With Benefit From Immune Checkpoint Inhibition in Advanced Gastroesophageal Cancer: Systematic Review and Meta-analysis of 17 Phase 3 Randomized Clinical Trials. JAMA oncology, 8:1456-1465, 2022

51. Kubota Y, Aoki Y, Kawazoe A, Shitara K. Role of Nivolumab in the Management of First-Line Unresectable Advanced or Recurrent Gastric Cancer in Combination with Chemotherapy: Lessons from the Japanese Experience. Cancer management and research, 14:3083-3094, 2022

52. El Helali A, Tao J, Wong CHL, Chan WW, Mok KC, Wu WF, Shitara K, Mohler M, Boku N, Pang H, Lam KO. A meta-analysis with systematic review: Efficacy and safety of immune checkpoint inhibitors in patients with advanced gastric cancer. Frontiers in oncology, 12:908026, 2022

53. Morinaga T, Inozume T, Kawazu M, Ueda Y, Sax N, Yamashita K, Kawashima S, Nagasaki J, Ueno T, Lin J, Ohara Y, Kuwata T, Yukami H, Kawazoe A, Shitara K, Honobe-Tabuchi A, Ohnuma T, Kawamura T, Umeda Y, Kawahara Y, Nakamura Y, Kiniwa Y, Morita A, Ichihara E, Kiura K, Enokida T, Tahara M, Hasegawa Y, Mano H, Suzuki Y, Nishikawa H, Togashi Y. Mixed Response to Cancer Immunotherapy is Driven by Intratumor Heterogeneity and Differential Interlesion Immune Infiltration. Cancer research communications, 2:739-753, 2022

54. Shimizu T, Kuboki Y, Lin CC, Yonemori K, Yanai T, Faller DV, Dobler L, Gupta N, Sedarati F, Kim KP. A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies. Targeted oncology, 17:15-24, 2022

55. Cao Y, Qin S, Luo S, Li Z, Cheng Y, Fan Y, Sun Y, Yin X, Yuan X, Li W, Liu T, Hsu CH, Lin X, Kim SB, Kojima T, Zhang J, Lee SH, Bai Y, Muro K, Doi T, Bai C, Gu K, Pan HM, Bai L, Yang JW, Cui Y, Lu W, Chen J. Pembrolizumab versus chemotherapy for patients with esophageal squamous cell carcinoma enrolled in the randomized KEYNOTE-181 trial in Asia. ESMO open, 7:100341, 2022

56. Shimizu T, Kuboki Y, Lin CC, Yonemori K, Yanai T, Faller DV, Dobler L, Gupta N, Sedarati F, Kim KP. Correction to: A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies. Targeted oncology, 17:377, 2022

57. LoRusso P, Ratain MJ, Doi T, Rasco DW, de Jonge MJA, Moreno V, Carneiro BA, Devriese LA, Petrich A, Modi D, Morgan-Lappe S, Nuthalapati S, Motwani M, Dunbar M, Glasgow J, Medeiros BC, Calvo E. Eftozanermin alfa (ABBV-621) monotherapy in patients with previously treated solid tumors: findings of a phase 1, first-in-human study. Investigational new drugs, 40:762-772, 2022

58. Maio M, Amonkar MM, Norquist JM, Ascierto PA, Manzyuk L, Motola-Kuba D, Penel N, Cassier PA, Bariani GM, De Jesus Acosta A, Doi T, Longo F, Miller WH Jr, Oh DY, Gottfried M, Wang R, Norwood K, Marabelle A. Health-related quality of life in patients treated with pembrolizumab for microsatellite instability-high/mismatch repair-deficient advanced solid tumours: Results from the KEYNOTE-158 study. European journal of cancer (Oxford, England : 1990), 169:188-197, 2022

59. Maio M, Ascierto PA, Manzyuk L, Motola-Kuba D, Penel N, Cassier PA, Bariani GM, De Jesus Acosta A, Doi T, Longo F, Miller WH, Oh DY, Gottfried M, Xu L, Jin F, Norwood K, Marabelle A. Pembrolizumab in microsatellite instability high or mismatch repair deficient cancers: updated analysis from the phase II KEYNOTE-158 study. Annals of oncology, 33:929-938, 2022

60. Even C, Delord JP, Price KA, Nakagawa K, Oh DY, Burge M, Chung HC, Doi T, Fakih M, Takahashi S, Yao L, Jin F, Norwood K, Hansen AR. Evaluation of pembrolizumab monotherapy in patients with previously treated advanced salivary gland carcinoma in the phase 2 KEYNOTE-158 study. European journal of cancer (Oxford, England : 1990), 171:259-268, 2022

61. Wermke M, Felip E, Gambardella V, Kuboki Y, Morgensztern D, Hamed ZO, Liu M, Studeny M, Owonikoko TK. Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas. Future oncology (London, England), 18:2639-2649, 2022

62. Hong DS, Gopal AK, Shoushtari AN, Patel SP, He AR, Doi T, Ramalingam SS, Patnaik A, Sandhu S, Chen Y, Davis CB, Fisher TS, Huang B, Fly KD, Ribas A. Utomilumab in Patients With Immune Checkpoint Inhibitor-Refractory Melanoma and Non-Small-Cell Lung Cancer. Frontiers in immunology, 13:897991, 2022

63. Nishina T, Fujita T, Yoshizuka N, Sugibayashi K, Murayama K, Kuboki Y. Safety, tolerability, pharmacokinetics and preliminary antitumour activity of an antisense oligonucleotide targeting STAT3 (danvatirsen) as monotherapy and in combination with durvalumab in Japanese patients with advanced solid malignancies: a phase 1 study. BMJ open, 12:e055718, 2022

64. Hamid O, Chiappori AA, Thompson JA, Doi T, Hu-Lieskovan S, Eskens FALM, Ros W, Diab A, Spano JP, Rizvi NA, Wasser JS, Angevin E, Ott PA, Forgie A, Yang W, Guo C, Chou J, El-Khoueiry AB. First-in-human study of an OX40 (ivuxolimab) and 4-1BB (utomilumab) agonistic antibody combination in patients with advanced solid tumors. Journal for immunotherapy of cancer, 10:e005471, 2022

65. Van Cutsem E, Hochster H, Shitara K, Mayer R, Ohtsu A, Falcone A, Yoshino T, Doi T, Ilson DH, Arkenau HT, George B, Benhadji KA, Makris L, Tabernero J. Pooled safety analysis from phase III studies of trifluridine/tipiracil in patients with metastatic gastric or gastroesophageal junction cancer and metastatic colorectal cancer. ESMO open, 7:100633, 2022

Tsukiji

1. Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E(2) receptor 4, alone and with nivolumab in solid tumors. Cancer science, 114:211-220, 2023

2. Tanaka T, Yoshida T, Masuda K, Takeyasu Y, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Prognostic role of modified Glasgow Prognostic score in elderly non-small cell lung cancer patients treated with anti-PD-1 antibodies. Respiratory investigation, 61:74-81, 2023

3. Takamizawa S, Katsuya Y, Chen YN, Mizuno T, Koyama T, Sudo K, Yoshida T, Kondo S, Iwasa S, Yonemori K, Shimizu T, Yamamoto N, Suzuki S. Ocular toxicity of investigational anti-cancer drugs in early phase clinical trials. Investigational new drugs, 41:173-181, 2023

4. Fukuda A, Yoshida T, Yagishita S, Shiotsuka M, Kobayashi O, Iwata S, Umeguchi H, Yanagida M, Irino Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamada A, Yamamoto N, Ohe Y. Real-world Data on the Incidence of Coronavirus Disease (COVID-19) in Patients With Advanced Thoracic Cancer During the Early Phase of the Pandemic in Japan. Anticancer research, 43:919-926, 2023

5. Fujiwara Y, Makihara R, Hase T, Hashimoto N, Naito T, Tsubata Y, Okuno T, Takahashi T, Kobayashi H, Shinno Y, Zenke Y, Ikeda T, Hosomi Y, Watanabe K, Kitazono S, Sakiyama N, Makino Y, Yamamoto N. Pharmacokinetic and dose-finding study of osimertinib in patients with impaired renal function and low body weight. Cancer science, 114:2087-2097, 2023

6. Akagi K, Yagishita S, Ohuchi M, Hayashi Y, Takeyasu Y, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Mukae H, Ohe Y, Hamada A. Impact of ramucirumab pharmacokinetics in combination with docetaxel on the efficacy and survival in patients with advanced non-small cell lung cancer. Lung cancer (Amsterdam, Netherlands), 178:247-253, 2023

7. Shimizu T, Nakagawa K, Hayashi H, Iwasa T, Kawakami H, Watanabe S, Yamamoto N, Yonemori K, Koyama T, Sato J, Tamura K, Kikuchi K, Akaike K, Takeda S, Takeda M. Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study. Investigational new drugs, 41:1-12, 2023

8. Mizuno S, Ikegami M, Koyama T, Sunami K, Ogata D, Kage H, Yanagaki M, Ikeuchi H, Ueno T, Tanikawa M, Oda K, Osuga Y, Mano H, Kohsaka S. High-Throughput Functional Evaluation of MAP2K1 Variants in Cancer. Molecular cancer therapeutics, 22:227-239, 2023

9. Heymach J, Opdam F, Barve M, Gibson N, Sadrolhefazi B, Serra J, Yamamoto N. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations. Clinical lung cancer, 24:e65-e68, 2023

10. Asami Y, Kobayashi Kato M, Hiranuma K, Matsuda M, Shimada Y, Ishikawa M, Koyama T, Komatsu M, Hamamoto R, Nagashima M, Terao Y, Itakura A, Kohno T, Sekizawa A, Matsumoto K, Kato T, Shiraishi K, Yoshida H. Utility of molecular subtypes and genetic alterations for evaluating clinical outcomes in 1029 patients with endometrial cancer. British journal of cancer, 128:1582-1591, 2023

11. Shimada K, Nakamura K, Yamamoto N. Mission of the National Cancer Center Hospital in Japan to promote clinical trials for precision medicine. Cancer biology & medicine, j.issn.2095-3941.2022.0643, 2023

12. Higashiyama RI, Horinouchi H, Kuchiba A, Matsumoto Y, Murakami S, Goto Y, Kanda S, Fujiwara Y, Yamamoto N, Ohe Y. Non-specific symptoms as a prodrome of immune-related adverse events in patients with non-small cell lung cancer receiving nivolumab: a consecutive analysis of 200 patients. Journal of cancer research and clinical oncology, 2022

13. So C, Yoshida T, Mizuno T, Yatabe Y, Ohe Y. Rapidly progressing metastatic malignant melanoma mimicking primary pleural tumor: A case report. Thoracic cancer, 13:1423-1426, 2022

14. Torasawa M, Yoshida T, Yagishita S, Shimoda Y, Shirasawa M, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Takahashi K, Ohe Y. Nivolumab versus pembrolizumab in previously-treated advanced non-small cell lung cancer patients: A propensity-matched real-world analysis. Lung cancer (Amsterdam, Netherlands), 167:49-57, 2022

15. Koyama T, Shimizu T, Sato J, Katsuya Y, Iwasa S, Kondo S, Yoshida T, Sudo K, Nishino M, Takiguchi Y, Yonemori K, Yamamoto N. Practical consideration for successful sequential tumor biopsies in first-in-human trials. Investigational new drugs, 40:841-849, 2022

16. Takeyasu Y, Yoshida T, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Lorlatinib Versus Pemetrexed-Based Chemotherapy in Patients With ALK-rearranged NSCLC Previously Treated With Alectinib. JTO clinical and research reports, 3:100311, 2022

17. Shinno Y, Yoshida A, Masuda K, Matsumoto Y, Okuma Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Yatabe Y, Ohe Y. Efficacy of Immune Checkpoint Inhibitors in SMARCA4-Deficient Thoracic Tumor. Clinical lung cancer, 23:386-392, 2022

18. Shimoda Y, Shibaki R, Yoshida T, Murakami S, Shirasawa M, Torasawa M, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y, Motoi N. Concurrent High PD-L1 Expression and CD8(+) Immune Cell Infiltration Predict PD-1 Blockade Efficacy in Advanced EGFR-Mutant NSCLC Patients. Clinical lung cancer, 23:477-486, 2022

19. Seki Y, Yoshida T, Kohno T, Masuda K, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Kuwano K, Ohe Y. Liquid biopsy for the detection of resistance mutations to ROS1 and RET inhibitors in non-small lung cancers: A case series study. Respiratory investigation, 60:852-856, 2022

20. Ida H, Koyama T, Mizuno T, Sunami K, Kubo T, Sudo K, Tao K, Hirata M, Yonemori K, Kato K, Okusaka T, Ohe Y, Matsui Y, Yamazaki N, Ogawa C, Kawai A, Narita Y, Esaki M, Yamamoto N. Clinical utility of comprehensive genomic profiling tests for advanced or metastatic solid tumor in clinical practice. Cancer science, 113:4300-4310, 2022

21. Ohuchi M, Yagishita S, Jo H, Akagi K, Inaba Higashiyama R, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Horinouchi H, Makino Y, Yamamoto N, Ohe Y, Hamada A. Early change in the clearance of pembrolizumab reflects the survival and therapeutic response: A population pharmacokinetic analysis in real-world non-small cell lung cancer patients. Lung cancer (Amsterdam, Netherlands), 173:35-42, 2022

22. Katsuya Y, Kitano S, Yamashita M, Ouchi M, Yagishita S, Hamada A, Nakamura H, Hosoda F, Shibata T, Motoi N, Nakayama T, Seto T, Umemura S, Hosomi Y, Satouchi M, Nishio M, Kozuki T, Hida T, Ohe Y, Horinouchi H. Comprehensive biomarker analysis from phase II study of nivolumab in patients with thymic carcinoma. Frontiers in oncology, 12:966527, 2022

23. Nishimura R, Ishiki H, Sato J, Satomi E. Dexamethasone for cancer-related dyspnoea. The Lancet. Oncology, 23:e525, 2022

24. Sato J, Shimizu T, Koyama T, Iwasa S, Shimomura A, Kondo S, Kitano S, Yonemori K, Fujiwara Y, Tamura K, Suzuki T, Takase T, Nagai R, Yamaguchi K, Semba T, Zhao ZM, Ren M, Yamamoto N. Dose Escalation Data from the Phase 1 Study of the Liposomal Formulation of Eribulin (E7389-LF) in Japanese Patients with Advanced Solid Tumors. Clinical cancer research, 28:1783-1791, 2022

25. Doki Y, Ueno M, Hsu CH, Oh DY, Park K, Yamamoto N, Ioka T, Hara H, Hayama M, Nii M, Komuro K, Sugimoto M, Tahara M. Tolerability and efficacy of durvalumab, either as monotherapy or in combination with tremelimumab, in patients from Asia with advanced biliary tract, esophageal, or head-and-neck cancer. Cancer medicine, 11:2550-2560, 2022

26. Yonemori K, Kuboki Y, Hasegawa K, Iwata T, Kato H, Takehara K, Hirashima Y, Kato H, Passey C, Buchbjerg JK, Harris JR, Andreassen CM, Nicacio L, Soumaoro I, Fujiwara K. Tisotumab vedotin in Japanese patients with recurrent/metastatic cervical cancer: Results from the innovaTV 206 study. Cancer science, 113:2788-2797, 2022

27. Ishihara M, Kitano S, Kageyama S, Miyahara Y, Yamamoto N, Kato H, Mishima H, Hattori H, Funakoshi T, Kojima T, Sasada T, Sato E, Okamoto S, Tomura D, Nukaya I, Chono H, Mineno J, Kairi MF, Diem Hoang Nguyen P, Simoni Y, Nardin A, Newell E, Fehlings M, Ikeda H, Watanabe T, Shiku H. NY-ESO-1-specific redirected T cells with endogenous TCR knockdown mediate tumor response and cytokine release syndrome. Journal for immunotherapy of cancer, 10:e003811, 2022

28. Hosomi Y, Seto T, Nishio M, Goto K, Yamamoto N, Okamoto I, Tajima K, Kajihara Y, Yamamoto N. Erlotinib with or without bevacizumab as a first-line therapy for patients with advanced nonsquamous epidermal growth factor receptor-positive non-small cell lung cancer: Exploratory subgroup analyses from the phase II JO25567 study. Thoracic cancer, 13:2192-2200, 2022

29. Higashiyama RI, Yoshida T, Yagishita S, Ohuchi M, Sakiyama N, Torasawa M, Shirasawa M, Masuda K, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Hamada A, Ohe Y. Safety Implications of Switching Pembrolizumab Dosage From 200 mg Every 3 Weeks to 400 mg Every 6 Weeks in Patients With Advanced NSCLC. Journal of thoracic oncology, 17:1227-1232, 2022

30. Imai M, Nakamura Y, Sunami K, Kage H, Komine K, Koyama T, Amano T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Bando H, Makiyama A, Suzuki T, Hirata M, Kohsaka S, Tsuchihara K, Naito Y, Yoshino T. Expert panel consensus recommendations on the use of circulating tumor DNA assays for patients with advanced solid tumors. Cancer science, 113:3646-3656, 2022

31. Shimizu T, Nakajima TE, Yamamoto N, Yonemori K, Koyama T, Kondo S, Sunakawa Y, Izawa N, Horie Y, Xiang S, Xu S, Qin L, Gong J, Liu D. Phase I study of envafolimab (KN035), a novel subcutaneous single-domain anti-PD-L1 monoclonal antibody, in Japanese patients with advanced solid tumors. Investigational new drugs, 40:1021-1031, 2022

32. Sunami K, Naito Y, Komine K, Amano T, Ennishi D, Imai M, Kage H, Kanai M, Kenmotsu H, Koyama T, Maeda T, Morita S, Sakai D, Kohsaka S, Tsuchihara K, Saigusa Y, Yoshino T. Chronological improvement in precision oncology implementation in Japan. Cancer science, 113:3995-4000, 2022

33. Mizuno T, Katsuya Y, Sato J, Koyama T, Shimizu T, Yamamoto N. Emerging PD-1/PD-L1 targeting immunotherapy in non-small cell lung cancer: Current status and future perspective in Japan, US, EU, and China. Frontiers in oncology, 12:925938, 2022

34. Wu YL, Lu S, Yang JC, Zhou J, Seto T, Ahn MJ, Su WC, Yamamoto N, Kim DW, Paolini J, Usari T, Iadeluca L, Wilner KD, Goto K. Final Overall Survival, Safety, and Quality of Life Results From a Phase 2 Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced NSCLC. JTO clinical and research reports, 3:100406, 2022

35. Kitano S, Fujiwara Y, Shimizu T, Iwasa S, Yonemori K, Kondo S, Shimomura A, Koyama T, Ebata T, Ikezawa H, Hayata N, Minoshima Y, Miura T, Kubota T, Yamamoto N. A feasibility study of lenvatinib plus pembrolizumab in Japanese patients with advanced solid tumors. Cancer chemotherapy and pharmacology, 90:523-529, 2022

36. Hamamoto R, Koyama T, Kouno N, Yasuda T, Yui S, Sudo K, Hirata M, Sunami K, Kubo T, Takasawa K, Takahashi S, Machino H, Kobayashi K, Asada K, Komatsu M, Kaneko S, Yatabe Y, Yamamoto N. Introducing AI to the molecular tumor board: one direction toward the establishment of precision medicine using large-scale cancer clinical and biological information. Experimental hematology & oncology, 11:82, 2022

37. Kondo S, Iwasa S, Koyama T, Fujita T, Sugibayashi K, Murayama K, Yamamoto N. Safety, tolerability, pharmacokinetics, and antitumour activity of oleclumab in Japanese patients with advanced solid malignancies: a phase I, open-label study. International journal of clinical oncology, 27:1795-1804, 2022

38. Naito Y, Sunami K, Kage H, Komine K, Amano T, Imai M, Koyama T, Ennishi D, Kanai M, Kenmotsu H, Maeda T, Morita S, Sakai D, Watanabe K, Shirota H, Kinoshita I, Yoshioka M, Mamesaya N, Ito M, Kohsaka S, Saigusa Y, Yamamoto K, Hirata M, Tsuchihara K, Yoshino T. Concordance Between Recommendations From Multidisciplinary Molecular Tumor Boards and Central Consensus for Cancer Treatment in Japan. JAMA network open, 5:e2245081, 2022

39. Yoshimura K, Yamanoi K, Kanai M, Okunomiya A, Sagae Y, Sunada M, Taki M, Ukita M, Chigusa Y, Horie A, Yamaguchi K, Hamanishi J, Minamiguchi S, Yamamoto N, Muto M, Mandai M. Nivolumab for malignant transformation of ovarian mature cystic teratoma. Gynecologic oncology reports, 44:101115, 2022