Annual Report 2024

Division of Experimental Therapeutics

Kashiwa: Toshihiko Doi, Yoichi Naito, Kohei Shitara, Kenichi Harano, Yasutoshi Kuboki, Junichiro Yuda, Shigehiro Koganemaru

Tsukiji: Noboru Yamamoto, Takafumi Koyama, Kan Yonemori, Hirokazu Shoji, Kazuki Sudo, Tatsuya Yoshida, Jun Sato, Yuki Katsuya, Mao Okada, Yuta Maruki

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 have 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 Hospital East (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 on promising results proceed more rapidly and in greater depth.

List of papers published in 2024

Journal

1. Ghelardi F, Fucà G, Cavalli C, Shitara K, Cohen R, Ambrosini M, Maron SB, Cerantola R, Nasca V, Liberti GD, Zambelli L, Palazzo M, Salati M, Aoki Y, Kawazoe A, Cowzer D, Lonardi S, André T, Randon G, Pietrantonio F. The Prognostic Nutritional Index in patients with microsatellite instability-high metastatic gastric or gastroesophageal cancers receiving immune checkpoint inhibitors. Digestive and liver disease, 57:23-29, 2025

2. Konno Y, Mayama M, Takehara K, Yokoyama Y, Suzuki J, Susumu N, Harano K, Nakagawa S, Nakanishi T, Yamagami W, Yoshihara K, Nomura H, Okamoto A, Aoki D, Watari H. Prognostic impact of the number of resected pelvic nodes in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis. Journal of gynecologic oncology, 36:e3, 2025

3. Pavlakis N, Shitara K, Sjoquist K, Martin A, Jaworski A, Tebbutt N, Bang YJ, Alcindor T, O'Callaghan C, Strickland A, Rha SY, Lee KW, Kim JS, Bai LY, Hara H, Oh DY, Yip S, Zalcberg J, Price T, Simes J, Goldstein D. INTEGRATE IIa Phase III Study: Regorafenib for Refractory Advanced Gastric Cancer. Journal of clinical oncology, 43:453-463, 2025

4. Umemura S, Udagawa H, Ikeda T, Murakami H, Daga H, Toyozawa R, Kozuki T, Sakakibara-Konishi J, Ohe Y, Morise M, Kato T, Shingyoji M, Hara S, Furuya N, Teranishi S, Takata S, Miyamoto S, Nakachi I, Wakabayashi M, Nomura S, Sato A, Ishii G, Tsuchihara K, Sugiyama E, Kirita K, Sakai T, Shibata Y, Izumi H, Nosaki K, Zenke Y, Matsumoto S, Yoh K, Niho S, Goto K. Clinical Significance of a Prospective Large Genomic Screening for SCLC: The Genetic Classification and a Biomarker-Driven Phase 2 Trial of Gedatolisib. Journal of thoracic oncology, 20:177-193, 2025

5. Yuda J, Wang C, Terasawa T, Tajimi M, Osaga S, Miura M, Takaoka S, Tanizawa Y. Treatment selection and influencing factors for chronic lymphocytic leukemia: a physician survey in Japan. International journal of clinical oncology, 30:157-167, 2025

6. Koganemaru S, Fuchigami H, Morizono C, Shinohara H, Kuboki Y, Furuuchi K, Uenaka T, Doi T, Yasunaga M. Potential Mechanisms of Interstitial Lung Disease Induced by Antibody-Drug Conjugates Based on Quantitative Analysis of Drug Distribution. Molecular cancer therapeutics, 24:242-250, 2025

7. Okazawa-Sakai M, Sakai SA, Hyodo I, Horasawa S, Sawada K, Fujisawa T, Yamamoto Y, Boku S, Hayasaki Y, Isobe M, Shintani D, Hasegawa K, Egawa-Takata T, Ito K, Ihira K, Watari H, Takehara K, Yagi H, Kato K, Chiyoda T, Harano K, Nakamura Y, Yamashita R, Yoshino T, Aoki D. Gut microbiome associated with PARP inhibitor efficacy in patients with ovarian cancer. Journal of gynecologic oncology, 36:e38, 2025

8. Jubashi A, Nakayama I, Koganemaru S, Sakamoto N, Oda S, Matsubara Y, Miyashita Y, Sato S, Ushiyama S, Kobayashi A, Okazaki U, Okemoto D, Yamamoto K, Mishima S, Kotani D, Kawazoe A, Hashimoto T, Nakamura Y, Kuboki Y, Bando H, Kojima T, Yoshino T, Miyaaki H, Nakao K, Shitara K. Prognostic and predictive factors for the efficacy and safety of trastuzumab deruxtecan in HER2-positive gastric or gastroesophageal junction cancer. Gastric cancer, 28:63-73, 2025

9. Oi H, Taki T, Kuroe T, Sakamoto N, Sakashita S, Kojima M, Sugiyama E, Umemura S, Sakai T, Izumi H, Zenke Y, Matsumoto S, Yoh K, Ishii M, Tsuboi M, Goto K, Ishii G. NETosis in pulmonary pleomorphic carcinoma. Cancer science, 116:524-532, 2025

10. Iwata H, Naito Y, Hattori M, Yoshimura A, Yonemori K, Aizawa M, Mori Y, Yoshimitsu J, Umeyama Y, Mukohara T. Safety and pharmacokinetics of vepdegestrant in Japanese patients with ER+ advanced breast cancer: a phase 1 study. International journal of clinical oncology, 30:72-82, 2025

11. Tsuge A, Watanabe S, Kawazoe A, Togashi Y, Itahashi K, Masuda M, Sai A, Takei S, Muraoka H, Ohkubo S, Sugiyama D, Yan Y, Fukuoka S, Doi T, Shitara K, Koyama S, Nishikawa H. The HSP90 Inhibitor Pimitespib Targets Regulatory T Cells in the Tumor Microenvironment. Cancer immunology research, 13:273-285, 2025

12. Nakagawa K, Garon EB, Seto T, Nishio M, Aix SP, Paz-Ares L, Chiu CH, Park K, Novello S, Nadal E, Nishino K, Yoh K, Shih JY, Chik JYK, Moro-Sibilot D, Puri T, Chacko Varughese S, Frimodt-Moller B, Visseren-Grul C, Reck M. RELAY: Final Overall Survival for Erlotinib Plus Ramucirumab or Placebo in Untreated, EGFR-Mutated Metastatic NSCLC. Journal of thoracic oncology, 20:487-499, 2025

13. Nakayama I, Nakamura Y, Shitara K. The immunotherapy challenge in locally advanced gastroesophageal cancer: VESTIGE trial's insights and future pathways. Annals of oncology, 36:130-133, 2025

14. Sonehara K, Tateishi K, Yoh K, Usui K, Hosomi Y, Kishi K, Naka G, Watanabe K, Tamano S, Uemura K, Kunitoh H. Real-World Study of EGFR-TKI Rechallenge With Another TKI After First-Line Osimertinib Discontinuation in Patients With EGFR-Mutated Non-Small Cell Lung Cancer: A Subset Analysis of the Reiwa Study. Thoracic cancer, 16:e15507, 2025

15. Awano N, Yoh K, Usui K, Hosomi Y, Kishi K, Naka G, Watanabe K, Tamano S, Uemura K, Kunitoh H. Outcome of osimertinib-treated patients with epidermal growth factor receptor mutation-positive nonsmall cell lung cancer requiring dose reduction: a secondary analysis of the Reiwa study. Japanese journal of clinical oncology, 55:261-268, 2025

16. Koganemaru S, Koyama S, Suto F, Koga M, Inaki K, Kuwahara Y, Arita T, Hirata T, Goto H, Wada N, Kobayashi M, Shibutani T, Okabayashi T, Nakamaru K, Kawazoe A, Togashi Y, Nishikawa H, Shitara K. The Tumor Immune Microenvironment and Therapeutic Efficacy of Trastuzumab Deruxtecan in Gastric Cancer. Cancer research communications, 5:84-93, 2025

17. Kobayashi T, Watanabe K, Hosomi Y, Yoh K, Usui K, Kishi K, Naka G, Tamano S, Uemura K, Kunitoh H. Clinical outcomes of patients with EGFR-mutated NSCLC developing interstitial lung disease during first-line osimertinib therapy: a sub-analysis of the Reiwa study. Japanese journal of clinical oncology, 55:275-282, 2025

18. Hirata T, Watanabe K, Hosomi Y, Yoh K, Usui K, Kishi K, Naka G, Tamano S, Uemura K, Kunitoh H. Observational study of the efficacy and safety of first-line osimertinib and later treatments for uncommon epidermal growth factor receptor-activating mutation-positive advanced non-small cell lung cancer. Japanese journal of clinical oncology, 55:269-274, 2025

19. Bando H, Naito Y, Yamada T, Fujisawa T, Imai M, Sakamoto Y, Saigusa Y, Yamamoto K, Tomioka Y, Takeshita N, Sunami K, Futamura M, Notake C, Aoki S, Okano K, Yoshino T. A prospective study comparing highly qualified Molecular Tumor Boards with AI-powered software as a medical device. International journal of clinical oncology, 30:172-179, 2025

20. Ito Y, Zenke Y, Sakai T, Shibata Y, Izumi H, Nosaki K, Umemura S, Matsumoto S, Yoh K, Nakamura M, Hojo H, Izumo T, Goto K. A simplified scoring system for predicting treatment response in limited-stage small-cell lung cancer (EAST score). Future oncology (London, England), 21:473-481, 2025

21. Aoki Y, Nakayama I, Shitara K. Human Epidermal Growth Factor Receptor 2 Positive Advanced Gastric or Esophagogastric Adenocarcinoma: Reflecting on the Past to Gain a New Insights. Current oncology reports, 27:15-29, 2025

22. Sands J, Ahn MJ, Lisberg A, Cho BC, Blumenschein G Jr, Shum E, Pons Tostivint E, Goto Y, Yoh K, Heist R, Shimizu J, Lee JS, Baas P, Planchard D, Pérol M, Felip E, Su WC, Zebger-Gong H, Lan L, Liu C, Howarth P, Chiaverelli R, Paz-Ares L. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. Journal of clinical oncology, 43:1254-1265, 2025

23. Nagata H, Kinoshita T, Sakashita S, Kojima M, Taki T, Kuwata T, Yura M, Shitara K, Ishii G, Sakamoto N. Area of Residual Tumor Measurement After Preoperative Chemotherapy as an Objective and Quantitative Method for Predicting the Prognosis of Gastric Cancer: A Single-Center Retrospective Study. World journal of surgery, 49:717-726, 2025

24. Misawa S, Denda T, Kodama S, Suzuki T, Naito Y, Kogawa T, Takada M, Hino A, Shiosakai K, Kuwabara S. One-year incidence of chemotherapy-induced peripheral neuropathy in oxaliplatin- or taxane-based chemotherapy: a multicenter, prospective registry study (MiroCIP study). Expert opinion on pharmacotherapy, 26:335-344, 2025

25. Nakayama I, Shitara K. Cell-Based Therapies in GI Cancers: Current Landscape and Future Directions. American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting, 45:e471716, 2025

26. Rha SY, Zhang Y, Elme A, Pazo Cid R, Alacacioglu A, Ziogas DC, Shitara K, Ranceva A, Nemecek R, Santoro A, Calderon CA, Korphaisarn K, Davis T, Zahlten-Kuemeli A, Conn C, Tan M, Honeycutt H, Wainberg ZA. Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. JCO precision oncology, 9:e2400710, 2025

27. Satoh T, Barthélémy P, Nogova L, Honda K, Hirano H, Lee KW, Rha SY, Ryu MH, Park JO, Doi T, Ajani J, Hangai N, Kremer J, Mina M, Liu M, Shitara K. Phase 2 study of futibatinib in patients with gastric or gastroesophageal junction cancer harboring FGFR2 amplifications. European journal of cancer (Oxford, England : 1990), 218:115262, 2025

28. Konno Y, Mayama M, Takehara K, Yokoyama Y, Suzuki J, Susumu N, Harano K, Nakagawa S, Nakanishi T, Yamagami W, Yoshihara K, Nomura H, Okamoto A, Aoki D, Watari H. Prognostic significance of para-aortic node metastasis in endometrial cancer: Japanese Gynecologic Oncology Group Study JGOG2043 post hoc analysis. Journal of gynecologic oncology, 2025

29. Bando H, Kumagai S, Kotani D, Mishima S, Irie T, Itahashi K, Tanaka Y, Habu T, Fukaya S, Kondo M, Tsushima T, Hara H, Kadowaki S, Kato K, Chin K, Yamaguchi K, Kageyama SI, Hojo H, Nakamura M, Tachibana H, Wakabayashi M, Fukui M, Fuse N, Koyama S, Mano H, Nishikawa H, Shitara K, Yoshino T, Kojima T. Atezolizumab following definitive chemoradiotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma - a multicenter phase 2 trial (EPOC1802). Nature cancer, 6:445-459, 2025

30. Marabelle A, O'Malley DM, Hendifar AE, Ascierto PA, Motola-Kuba D, Penel N, Cassier PA, Bariani G, De Jesus-Acosta A, Doi T, Longo F, Miller WH Jr, Oh DY, Gottfried M, Yao L, Jin F, Gozman A, Maio M. Pembrolizumab in microsatellite-instability-high and mismatch-repair-deficient advanced solid tumors: updated results of the KEYNOTE-158 trial. Nature cancer, 6:253-258, 2025

31. Harada K, Sakamoto N, Kitaoka T, Nakamura Y, Kondo R, Morisue R, Hashimoto H, Yamamoto Y, Ukai S, Maruyama R, Sakashita S, Kojima M, Tanabe K, Ohdan H, Shitara K, Kinoshita T, Ishii G, Yasui W, Ochiai A, Ishikawa S. PI3 expression predicts recurrence after chemotherapy with DNA-damaging drugs in gastric cancer. The Journal of pathology, 265:472-485, 2025

32. Uehara Y, Izumi H, Taki T, Sakai T, Udagawa H, Sugiyama E, Umemura S, Zenke Y, Matsumoto S, Yoh K, Kubota S, Aokage K, Sakamoto N, Sakashita S, Kojima M, Nagamine M, Hosomi Y, Tsuboi M, Goto K, Ishii G. Solid Predominant Histology and High Podoplanin Expression in Cancer-Associated Fibroblast Predict Primary Resistance to Osimertinib in EGFR-Mutated Lung Adenocarcinoma. JTO clinical and research reports, 6:100779, 2025

33. Luo HY, Lu YX, Shitara K, Lenz HJ, Xu RH. Global alliances in translational cancer research. Cancer cell, 43:581-586, 2025

34. Heymach JV, Opdam F, Barve M, Tu HY, Wu YL, Berz D, Schröter L, Botilde Y, Sadrolhefazi B, Serra J, Yoh K, Yamamoto N. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study. Journal of clinical oncology, 43:1337-1347, 2025

35. Shitara K, Janjigian YY, Ajani J, Moehler M, Yao J, Wang X, Chhibber A, Pandya D, Shen L, Garrido M, Gallardo C, Wyrwicz L, Yamaguchi K, Skoczylas T, Bragagnoli A, Liu T, Schenker M, Yañez P, Kowalyszyn R, Karamouzis M, Zander T, Feeney K, Elimova E, Doshi P, Li M, Lei M. Nivolumab plus chemotherapy or ipilimumab in gastroesophageal cancer: exploratory biomarker analyses of a randomized phase 3 trial. Nature medicine, 31:1519-1530, 2025

36. Uehara Y, Izumi H, Kobayashi IS, Matsumoto S, Hosomi Y, Okuno T, Sugisaka J, Takase N, Taima K, Sasaki S, Teranishi S, Miyamoto S, Mori M, Nakashima C, Asano S, Oi H, Sakai T, Shibata Y, Udagawa H, Sugiyama E, Nosaki K, Umemura S, Zenke Y, Yoh K, Ikeda S, Costa DB, Kobayashi SS, Goto K. Efficacy of EGFR tyrosine kinase inhibitors in patients with non-small cell lung cancer with EGFR exon 19 insertions: clinical-genomic, preclinical analysis through LC-SCRUM-Asia (multi-institutional genomic screening registry). Lung cancer (Amsterdam, Netherlands), 202:108479, 2025

37. Takei S, Kotani D, Laliotis G, Sato K, Fujiwara N, Kawazoe A, Hashimoto T, Mishima S, Nakayama I, Nakamura Y, Bando H, Kuboki Y, Sakashita S, Spickard E, George GV, Dutta P, Sharma S, Malhotra M, Sethi H, Jurdi A, Liu MC, Yoshino T, Shitara K, Kojima T, Fujita T. Circulating Tumor DNA Assessment to Predict Risk of Recurrence after Surgery in Patients with Locally Advanced Esophageal Squamous Cell Carcinoma: A Prospective Observational Study. Annals of surgery, 2025

38. Janjigian YY, Cecchini M, Shitara K, Enzinger PC, Wainberg ZA, Chau I, Satoh T, Lee J, Nebozhyn M, Loboda A, Kobie J, Vajdi A, Shih CS, Cristescu R, Cao ZA. Genomic Landscape of Late-Stage Gastric Cancer: Analysis From KEYNOTE-059, KEYNOTE-061, and KEYNOTE-062 Studies. JCO precision oncology, 9:e2400456, 2025

39. Biesdorf C, Guan X, Siddani SR, Hoffman D, Boehm N, Medeiros BC, Doi T, de Jonge M, Rasco D, Menon RM, Polepally AR. Pharmacokinetics and immunogenicity of eftozanermin alfa in subjects with previously-treated solid tumors or hematologic malignancies: results from a phase 1 first-in-human study. Cancer chemotherapy and pharmacology, 93:329-339, 2024

40. Doi T, Takahashi S, Aoki D, Yonemori K, Hara H, Hasegawa K, Takehara K, Harano K, Yunokawa M, Nomura H, Shimoi T, Horie K, Ogasawara A, Okame S. A first-in-human phase I study of TAS-117, an allosteric AKT inhibitor, in patients with advanced solid tumors. Cancer chemotherapy and pharmacology, 93:605-616, 2024

41. Tsukita Y, Taguri M, Goto Y, Hosomi Y, Mizutani T, Watanabe K, Yoh K, Takahashi S, Kubota K, Kunitoh H. Multi-institutional study of osimertinib dose-optimization in non-small cell lung cancer patients with EGFR activating mutation aged 70 years or older ('MONEY' trial). Japanese journal of clinical oncology, 54:730-734, 2024

42. Yamamoto N, Satouchi M, Doi T, Fujiwara Y, Yanagitani N, Kawa Y, Yoh K, Leopold L, Munteanu M, Sawada T, Han S, Noguchi K, Nishio M. KEYNOTE-434 part B: A phase 1 study evaluating the combination of epacadostat, pembrolizumab, and chemotherapy in Japanese patients with previously untreated advanced non-small-cell lung cancer. Investigational new drugs, 42:261-271, 2024

43. Hashimoto T, Nakamura Y, Oki E, Kobayashi S, Yuda J, Shibuki T, Bando H, Yoshino T. Bridging horizons beyond CIRCULATE-Japan: a new paradigm in molecular residual disease detection via whole genome sequencing-based circulating tumor DNA assay. International journal of clinical oncology, 29:495-511, 2024

44. Mori S, Izumi H, Araki M, Liu J, Tanaka Y, Kagawa Y, Sagae Y, Ma B, Isaka Y, Sasakura Y, Kumagai S, Sakae Y, Tanaka K, Shibata Y, Udagawa H, Matsumoto S, Yoh K, Okuno Y, Goto K, Kobayashi SS. LTK mutations responsible for resistance to lorlatinib in non-small cell lung cancer harboring CLIP1-LTK fusion. Communications biology, 7:412, 2024

45. Kato K, Kojima T, Hara H, Tsuji A, Yasui H, Muro K, Satoh T, Ogata T, Ishihara R, Goto M, Baba H, Nishina T, Han S, Iwakami K, Yatsuzuka N, Doi T. First-line pembrolizumab plus chemotherapy for advanced/metastatic esophageal cancer: 1-year extended follow-up in the Japanese subgroup of the phase 3 KEYNOTE-590 study. Esophagus, 21:306-318, 2024

46. Hirota S, Tateishi U, Nakamoto Y, Yamamoto H, Sakurai S, Kikuchi H, Kanda T, Kurokawa Y, Cho H, Nishida T, Sawaki A, Ozaka M, Komatsu Y, Naito Y, Honma Y, Takahashi F, Hashimoto H, Udo M, Araki M, Nishidate S. English version of Japanese Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) issued by the Japan Society of Clinical Oncology. International journal of clinical oncology, 29:647-680, 2024

47. Kawamoto Y, Morizane C, Komatsu Y, Kondo S, Ueno M, Kobayashi S, Furukawa M, Lee L, Satoh T, Sakai D, Ikeda M, Imaoka H, Miura A, Hatanaka Y, Yokota I, Nakamura Y, Yoshino T. Phase II trial of niraparib for BRCA-mutated biliary tract, pancreatic and other gastrointestinal cancers: NIR-B. Future oncology (London, England), 20:1901-1907, 2024

48. Kuboki Y, Koyama T, Matsubara N, Naito Y, Kondo S, Harano K, Yonemori K, Yoh K, Gu Y, Mita T, Chen X, Ueda E, Yamamoto N, Doi T, Shimizu T. PD-1 inhibition with retifanlimab and/or arginase inhibition with INCB001158 in Japanese patients with solid tumors: A phase I study. Cancer medicine, 13:e6980, 2024

49. Okahisa M, Udagawa H, Matsumoto S, Kato T, Yokouchi H, Furuya N, Kanemaru R, Toyozawa R, Nishiyama A, Ohashi K, Miyamoto S, Nishino K, Nakamura A, Iwama E, Niho S, Oi H, Sakai T, Shibata Y, Izumi H, Sugiyama E, Nosaki K, Umemura S, Zenke Y, Yoh K, Kah Mun Low G, Zhuo J, Goto K. Clinical outcomes in patients with non-small cell lung cancer harboring EGFR Exon20 in-frame insertions in the near-loop and far-loop: Results from LC-SCRUM-Asia. Lung cancer (Amsterdam, Netherlands), 191:107798, 2024

50. Sun JM, Adenis A, C Enzinger P, Shah MA, Kato K, Bennouna J, Doi T, Hawk NN, Yu L, Shah S, Bhagia P, Shen L. LEAP-014: first-line lenvatinib + pembrolizumab + chemotherapy in advanced/metastatic esophageal squamous cell carcinoma. Future oncology (London, England), 20:2709-2721, 2024

51. Kakuwa T, Watanabe T, Niino M, Kawata A, Satoh T, Matsumura N, Yokoyama Y, Kawana K, Hirashima Y, Kyo S, Yasuda M, Harano K, Machida H, Tokunaga H, Kaneuchi M, Tabata T, Kobayashi Y, Nagase S, Katabuchi H, Mikami M, Yamamoto Y, Rikitake R, Ichinose Y, Higashi T. Quality of care measurement for patients with ovarian cancer in Japan. The journal of obstetrics and gynaecology research, 50:1182-1191, 2024

52. Li BT, Meric-Bernstam F, Bardia A, Naito Y, Siena S, Aftimos P, Anderson I, Curigliano G, de Miguel M, Kalra M, Oh DY, Park JO, Postel-Vinay S, Rha SY, Satoh T, Spanggaard I, Michelini F, Smith A, Machado KK, Saura C. Trastuzumab deruxtecan in patients with solid tumours harbouring specific activating HER2 mutations (DESTINY-PanTumor01): an international, phase 2 study. The Lancet. Oncology, 25:707-719, 2024

53. Tan RYC, Ong WS, Lee KH, Park S, Iqbal J, Park YH, Lee JE, Yu JH, Lin CH, Lu YS, Ono M, Ueno T, Naito Y, Onishi T, Lim GH, Tan SM, Lee HB, Koh J, Han W, Im SA, Tan VKM, Phyu N, Wong FY, Tan PH, Yap YS. Outcomes in Nonmetastatic Hormone Receptor-Positive HER2-Negative Pure Mucinous Breast Cancer: A Multicenter Cohort Study. Journal of the National Comprehensive Cancer Network : JNCCN, 22:e237121, 2024

54. Shitara K, Bang YJ, Iwasa S, Sugimoto N, Ryu MH, Sakai D, Chung HC, Kawakami H, Yabusaki H, Sakamoto Y, Nishina T, Inaki K, Kuwahara Y, Wada N, Suto F, Arita T, Sugihara M, Tsuchihashi Z, Saito K, Kojima A, Yamaguchi K. Trastuzumab deruxtecan in HER2-positive advanced gastric cancer: exploratory biomarker analysis of the randomized, phase 2 DESTINY-Gastric01 trial. Nature medicine, 30:1933-1942, 2024

55. Nosaki K, Yoh K, Toyozawa R, Horinouchi H, Morise M, Ohashi K, Murakami H, Satouchi M, Sakakibara-Konishi J, Yano S, Okumura F, Matsumoto S, Shimokawa M, Seto T, Goto K. Phase 2 trial of crizotinib in Japanese patients with advanced NSCLC harboring a MET gene alteration: a Co-MET study. International journal of clinical oncology, 29:1142-1151, 2024

56. Kohsaka S, Yagishita S, Shirai Y, Matsuno Y, Ueno T, Kojima S, Ikeuchi H, Ikegami M, Kitada R, Yoshioka KI, Toshimitsu K, Tabata K, Yokoi A, Doi T, Yamamoto N, Owa T, Hamada A, Mano H. A molecular glue RBM39-degrader induces synthetic lethality in cancer cells with homologous recombination repair deficiency. NPJ precision oncology, 8:117, 2024

57. Mansoor W, Joo S, Norquist JM, Kato K, Sun JM, Shah MA, Enzinger P, Adenis A, Doi T, Kojima T, Metges JP, Li Z, Kim SB, Cho BC, Sunpaweravong P, Alsina M, Goekkurt E, Suryawanshi S, Shah S, Shen L. Health-related quality-of-life analysis from KEYNOTE-590: pembrolizumab plus chemotherapy versus chemotherapy for advanced esophageal cancer. The oncologist, 29:e1324-e1335, 2024

58. Yamamoto N, Kuboki Y, Harano K, Koyama T, Kondo S, Hagiwara A, Suzuki N, Fujikawa E, Toyoizumi K, Mukai M, Doi T. A phase 1/1b, open-label, dose-escalation study of PD-1 inhibitor, cetrelimab alone and in combination with FGFR inhibitor, erdafitinib in Japanese patients with advanced solid tumors. Investigational new drugs, 42:376-385, 2024

59. Shitara K, Shah MA, Lordick F, Bang YJ, Ilson D, Van Cutsem E, Enzinger P, Kim SS, Klempner SJ, Moran D, Park JW, Bhattacharya P, Ajani JA, Xu RH. Zolbetuximab plus chemotherapy for locally advanced unresectable or metastatic stomach or gastroesophageal junction cancers: a plain language summary. Future oncology (London, England), 20:1861-1877, 2024

60. Katoh M, Nakayama I, Wainberg ZA, Shitara K, Katoh M. Monoclonal antibodies that target fibroblast growth factor receptor 2 isoform b and Claudin-18 isoform 2 splicing variants in gastric cancer and other solid tumours. Clinical and translational medicine, 14:e1736, 2024

61. Tsushima T, Sato N, Guo YM, Nakamura H, Kunisada K, Chi SG, Akie K, Takahashi Y, Nakamura S, Shimada K, Ishii G, Minami Y, Yuda J. Richter transformation acquiring PLCG2 mutation during Bruton tyrosine kinase inhibitors treatment. EJHaem, 5:642-645, 2024

62. Peterlin P, Saada-Bouzid E, Moskovitz M, Pigneux A, Yuda J, Sinnollareddy M, Henner WR, Chen D, Freise KJ, Leibman RS, Avigdor A, Shimizu T. First-in-human clinical trial results with ABBV-184, a first-in-class T-cell receptor/anti-CD3 bispecific protein, in adults with previously treated AML or NSCLC. Expert review of anticancer therapy, 24:893-904, 2024

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Book

1. Suzuki KGN, Hirosawa KM, Isogai T, Yasuda T, Hanashima S. Membrane dynamics of exosomes as revealed by single-molecule imaging. In: Baba Y, Hanayama R, Akita H, Yasui T (ed), Extracellular Fine Particles, Singapore, Springer Singapore, pp 69-80, 2025