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Annual Report 2024

Department of Experimental Therapeutics

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

Introduction

 In April 2015, the affiliation of the Department of Experimental Therapeutics was updated from the NCC-EPOC (cf. the Exploratory Oncology Research & Clinical Trial Center) to the NCC-Hospital. The goal of this department is to perform initial clinical evaluations of promising new anti-cancer compounds emerging from the laboratory in phase I trials.  The staff consists of specialists from various oncology fields (i.e., thoracic oncology, breast and medical oncology, gastro-intestinal oncology, hepato-biliary and pancreatic oncology, and immuno-oncology).

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 FIH trials, but we also perform phase I trials for solid tumors (i.e., all comers). We recently joined the global phase I trials to accelerate the new drug development in Japan. We hold web conferences or teleconferences with EU and US sites, and discuss patient enrollment and further developmental strategies. Routine web-conferences are also held between the NCC-Hospital (Tokyo) and the NCC-East hospital (Chiba) every Friday morning, and we share information on adverse events and patient enrollment and refer the candidates to each other to accelerate enrollment. Currently, most of the phase I trials in Japan (i.e., first in Japan phase I trials, first in human trials) are conducted at the NCC-Hospital and the NCC-East hospital with close collaboration.

Research Activities

 The elucidation of the proof of concept (POC) is essential in new anti-cancer drug development especially in early phases, so we conduct several translational research (TR) projects in collaboration with research institutes. Also, we are conducting TR with the pharmaceutical industry to discover new targets for anti-immune therapy using human tissue (tumor and normal tissue) samples. To facilitate the POC analysis in the phase I trials, a phase I biobank study has been launched in 2018.

Clinical Trials

 In fiscal year 2024, 104 phase I trials including 71 FIH trials were conducted.

Education

 In 2024, the 6th phase I & TR research workshop was held on September 29th at the NCC- Tsukiji campus.

 In 2024, the 6th NCCH & RI Tsukiji TR Board activity conference was held on December 4th at the NCC-Tsukiji campus.

List of papers published in 2024

Journal

1. Wilding B, Woelflingseder L, Baum A, Chylinski K, Vainorius G, Gibson N, Waizenegger IC, Gerlach D, Augsten M, Spreitzer F, Shirai Y, Ikegami M, Tilandyová S, Scharn D, Pearson MA, Popow J, Obenauf AC, Yamamoto N, Kondo S, Opdam FL, Bruining A, Kohsaka S, Kraut N, Heymach JV, Solca F, Neumüller RA. Zongertinib (BI 1810631), an Irreversible HER2 TKI, Spares EGFR Signaling and Improves Therapeutic Response in Preclinical Models and Patients with HER2-Driven Cancers. Cancer discovery, 15:119-138, 2025

2. Hamamoto R, Komatsu M, Yamada M, Kobayashi K, Takahashi M, Miyake M, Jinnai S, Koyama T, Kouno N, Machino H, Takahashi S, Asada K, Ueda N, Kaneko S. Current status and future direction of cancer research using artificial intelligence for clinical application. Cancer science, 116:297-307, 2025

3. Liu J, Farrow M, Seymour L, Desai J, Loong HH, Ivy P, Koyoma T, Cook N, Blagden S, Garralda E, Massard C, Tolcher AW, Adashek JJ, Zhang L, Zhao S, Shen L, Kurzrock R, El-Deiry WS, Subbiah V, Joshua AM. Accelerating the Future of Oncology Drug Development: The Role of Consortia in the Delivery of Precision Oncology Early Phase Clinical Trials. Journal of clinical oncology, 43:735-747, 2025

4. Masuda K, Yoshida T, Motoi N, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Watanabe SI, Hoshino T, Yatabe Y, Ohe Y. Schlafen 11 Expression in Patients With Small Cell Lung Cancer and Its Association With Clinical Outcomes. Thoracic cancer, 16:e15529, 2025

5. Katsuya Y, Ikeda M, Koyama T, Sato J, Okada M, Matsubara N, Kondoh C, Mukohara T, Watanabe K, Kotani D, Ogawa Y, Taoka S, Yamamoto N. A Phase I, First-In-Human Study of CBA-1205, an Anti-DLK1 Monoclonal Antibody, in Patients With Advanced Solid Tumors. Cancer science, 116:1012-1022, 2025

6. Fujii E, Kato MK, Ono H, Yamaguchi M, Higuchi D, Koyama T, Komatsu M, Hamamoto R, Ishikawa M, Kato T, Kohno T, Shiraishi K, Yoshida H. TP53 Mutations and PD-L1 Amplification in Vulvar Adenocarcinoma of the Intestinal Type: Insights From Whole Exome Sequencing of 2 Cases. International journal of gynecological pathology, 44:358-363, 2025

7. Nishimura R, Sudo K, Kitadai R, Kawachi A, Ito M, Hoshino M, Kita S, Saito A, Kojima Y, Maejima A, Noguchi E, Okuma HS, Koyama T, Shimoi T, Yonemori K. Treatment and Reasons for Choosing Treatment in Breast Cancer Patients Who Underwent Next-Generation Sequencing Test. Oncology, 1-10, 2025

8. Fujii H, Okuma Y, Hirata M, Shinno Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. EGFR-Mutated Lung Adenocarcinoma With Li-Fraumeni Syndrome: The Imperative for Germline Testing in Patients With a Family History, a Case Report. JTO clinical and research reports, 6:100691, 2025

9. Takeuchi T, Horinouchi H, Takasawa K, Mukai M, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Ohe Y, Miyake M, Watanabe H, Kusumoto M, Aoki T, Nishimura K, Hamamoto R. A series of natural language processing for predicting tumor response evaluation and survival curve from electronic health records. BMC medical informatics and decision making, 25:85, 2025

10. 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

11. Satoh H, Okuma Y, Shinno Y, Masuda K, Matsumoto Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Evolving treatments and prognosis in Stage IV non-small cell lung cancer: 20 years of progress of novel therapies. Lung cancer (Amsterdam, Netherlands), 202:108453, 2025

12. 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

13. Okada M, Suzuki E, Morizane C, Ogawa G, Sano Y, Imaoka H, Kobayashi S, Ikeda M, Okano N, Miwa H, Todaka A, Shimizu S, Mizuno N, Satoi S, Sano K, Tobimatsu K, Katanuma A, Masutomi K, Okusaka T, Ozaka M, Ueno M. Impact of clinically diagnosed liver cirrhosis in patients with intrahepatic cholangiocarcinoma treated with systemic chemotherapy: a subgroup analysis of JCOG1113. Japanese journal of clinical oncology, 55:594-602, 2025

14. Shiraishi K, Okada M, Yamamoto S, Matsubara Y, Masuishi T, Shimozaki K, Yamamoto Y, Hirose S, Sugiyama K, Furuta M, Machida N, Takahashi N, Yoshii T, Kito Y, Tsuzuki T, Boku S, Tsuchihashi K, Sugaya A, Takayama T, Komori A, Mitani S, Matsumoto T, Nishimura T, Hirata K. The efficacy and safety of FOLFOX therapy for advanced esophageal squamous cell carcinoma. Scientific reports, 15:8031, 2025

15. Hara H, Hijioka S, Yamashige D, Nagashio Y, Komori Y, Kuwada M, Fukuda S, Yagi S, Okamoto K, Agarie D, Chatto M, Okada M, Maruki Y, Morizane C, Ueno H, Saito Y, Yonemori K, Okusaka T. Clinical significance and efficacy of endoscopic ultrasound-guided tissue acquisition for para-aortic lymph node metastasis. Digestive endoscopy, 2025

16. Torasawa M, Yoshida T, Shiraishi K, Yagishita S, Ono H, Uehara Y, Miyakoshi J, Tateishi A, Igawa YS, Higashiyama RI, Mochizuki A, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamamoto R, Yamamoto N, Watanabe SI, Yatabe Y, Takahashi K, Kohno T, Ohe Y. Implications of EGFR expression on EGFR signaling dependency and adaptive immunity against EGFR-mutated lung adenocarcinoma. Lung cancer (Amsterdam, Netherlands), 202:108494, 2025

17. Kitadai R, Okuma Y, Shibata T, Kohno T, Koyama T. Tissue-agnostic target profiles and treatment efficacy in cancer patients: Insights from the C-CAT clinicogenomic repository. European journal of cancer (Oxford, England : 1990), 220:115380, 2025

18. Seto T, Nakane S, Ji L, Ueda Y, Sugano H, Takei N, Kobayashi M, Murayama A, Yamamoto N. Real-world safety and effectiveness of entrectinib in Japanese patients with ROS1 gene fusion-positive, unresectable, advanced/recurrent non-small cell lung cancer: Post-marketing surveillance. Lung cancer (Amsterdam, Netherlands), 203:108478, 2025

19. Fukushima T, Goto K, Hayashi T, Ikeda K, Hatayama T, Yamanaka R, Iwane K, Tasaka R, Kohada Y, Takemoto K, Kobatake K, Goriki A, Toshida A, Nakahara H, Motonaga M, Tokumo K, Fujii Y, Hayes CN, Okamoto W, Kubo T, Matsumoto T, Shiota M, Yamamoto N, Urabe Y, Hiyama E, Arihiro K, Hinoi T, Hinata N. Comprehensive genomic profiling testing in Japanese castration-resistant prostate cancer patients: results of a single-center retrospective cohort study. Japanese journal of clinical oncology, 54:175-181, 2024

20. Terashima Y, Hakozaki T, Uehara Y, Miyanaga A, Kasahara K, Seike M, Hosomi Y. Prognostic significance of initial tumor shrinkage in patients with stage III non-small cell lung cancer treated with durvalumab following chemoradiotherapy. International journal of clinical oncology, 29:115-123, 2024

21. Janku F, Kim TM, Iyer G, Spreafico A, Elez E, de Jonge M, Yamamoto N, van der Wekken AJ, Ascierto PA, Maur M, Marmé F, Kiladjian JJ, Basu S, Baffert F, Buigues A, Chen C, Cooke V, Giorgetti E, Kim J, McCarthy F, Moschetta M, Dummer R. First-in-human study of naporafenib (LXH254) with or without spartalizumab in adult patients with advanced solid tumors harboring MAPK signaling pathway alterations. European journal of cancer (Oxford, England : 1990), 196:113458, 2024

22. Ando Y, Shimoi T, Sunami K, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Progress report of a cross-organ and biomarker-based basket-type clinical trial: BELIEVE Trial. Cancer science, 115:555-563, 2024

23. Doi T, Yamamoto N, Ohkubo S. Pimitespib for the treatment of advanced gastrointestinal stromal tumors and other tumors. Future oncology (London, England), 20:507-519, 2024

24. Matsubara N, Kusuhara S, Yamamoto N, Sudo K, Yanagita M, Murayama K, Kawasumi H, Russell DL, Yin D, Shimizu T. Safety and pharmacokinetics of imaradenant (AZD4635) in Japanese patients with advanced solid malignancies: a phase I, open-label study. Cancer chemotherapy and pharmacology, 93:341-352, 2024

25. Ishimaru S, Shimoi T, Sunami K, Nakajima M, Ando Y, Okita N, Nakamura K, Shibata T, Fujiwara Y, Yamamoto N. Platform trial for off-label oncology drugs using comprehensive genomic profiling under the universal public healthcare system: the BELIEVE trial. International journal of clinical oncology, 29:89-95, 2024

26. Nishio M, Murakami S, Kawakami H, Okishio K, Tamiya M, Kobayashi H, Fujimoto D, Sugawara S, Kozuki T, Oya Y, Izumi H, Shiroyama T, Satouchi M, Yamamoto N, Kaname S, Matsuoka D, Otake Y, Takase T, Semba T, Azuma K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Small Cell Lung Cancer Cohort. Cancer research communications, 4:226-235, 2024

27. Yamamoto N, Koyama T, Sato J, Yoshida T, Sudo K, Iwasa S, Kondo S, Yonemori K, Kawasaki A, Satake K, Shibata S, Shimizu T. Phase I study of the anti-TIGIT antibody tiragolumab in combination with atezolizumab in Japanese patients with advanced or metastatic solid tumors. Cancer chemotherapy and pharmacology, 94:109-115, 2024

28. Kawazoe A, Yamamoto N, Sugimoto N, Kawakami H, Oshima T, Yamaguchi K, Hino K, Hirao M, Kurokawa Y, Kawakami T, Tsuda M, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Muro K. Phase II Study of the Liposomal Formulation of Eribulin (E7389-LF) in Combination with Nivolumab: Results from the Gastric Cancer Cohort. Clinical cancer research, 30:1264-1272, 2024

29. Shimoi T, Sunami K, Tahara M, Nishiwaki S, Tanaka S, Baba E, Kanai M, Kinoshita I, Shirota H, Hayashi H, Nishida N, Kubo T, Mamesaya N, Ando Y, Okita N, Shibata T, Nakamura K, Yamamoto N. Dabrafenib and trametinib administration in patients with BRAF V600E/R or non-V600 BRAF mutated advanced solid tumours (BELIEVE, NCCH1901): a multicentre, open-label, and single-arm phase II trial. EClinicalMedicine, 69:102447, 2024

30. Takeyasu Y, Yoshida T, Masuda K, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Distinct Progression and Efficacy of First-Line Osimertinib Treatment According to Mutation Subtypes in Metastatic NSCLC Harboring EGFR Mutations. JTO clinical and research reports, 5:100636, 2024

31. Shirai Y, Ueno T, Kojima S, Ikeuchi H, Kitada R, Koyama T, Takahashi F, Takahashi K, Ichimura K, Yoshida A, Sugino H, Mano H, Narita Y, Takahashi M, Kohsaka S. The development of a custom RNA-sequencing panel for the identification of predictive and diagnostic biomarkers in glioma. Journal of neuro-oncology, 167:75-88, 2024

32. Katsuya Y, Yoshida T, Takashima A, Yonemori K, Ohba A, Yazaki S, Yagishita S, Nakahama H, Kobayashi O, Yanagida M, Irino Y, Hamada A, Yamamoto N. Immunogenicity after vaccination of COVID-19 vaccines in patients with cancer: a prospective, single center, observational study. International journal of clinical oncology, 29:386-397, 2024

33. Heist RS, Sands J, Bardia A, Shimizu T, Lisberg A, Krop I, Yamamoto N, Kogawa T, Al-Hashimi S, Fung SSM, Galor A, Pisetzky F, Basak P, Lau C, Meric-Bernstam F. Clinical management, monitoring, and prophylaxis of adverse events of special interest associated with datopotamab deruxtecan. Cancer treatment reviews, 125:102720, 2024

34. 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

35. Takamizawa S, Koyama T, Sunami K, Sudo K, Hirata M, Kubo T, Tao K, Cho H, Narita Y, Kato K, Yamazaki N, Ohe Y, Okusaka T, Matsui Y, Ogawa C, Yonemori K, Yamamoto N. Identification of barriers to implementation of precision oncology in patients with rare cancers. Cancer science, 115:2023-2035, 2024

36. Yamamoto N, Tolcher A, Hafez N, Lugowska I, Ramlau R, Macarulla T, Geng J, Li J, Teufel M, Märten A, LoRusso P. Efficacy and Safety of the MDM2-p53 Antagonist Brigimadlin (BI 907828) in Patients with Advanced Biliary Tract Cancer: A Case Series. OncoTargets and therapy, 17:267-280, 2024

37. Miyakoshi J, Yoshida T, Kashima J, Shirasawa M, Torasawa M, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Shiraishi K, Kohno T, Yamamoto N, Yatabe Y, Suzuki T, Ohe Y. Clinical significance of inter-assay discrepancy in PD-L1 evaluation for the efficacy of pembrolizumab in advanced NSCLC with high PD-L1 expression. Lung cancer (Amsterdam, Netherlands), 191:107788, 2024

38. Kondo S, Katsuya Y, Yonemori K, Komuro K, Sugeno M, Kawata T, Ghiorghiu D, Meulendijks D, Yamamoto N. Safety, tolerability, pharmacokinetics, and antitumor activity of adavosertib in Japanese patients with advanced solid tumors: A phase I, open-label study. Cancer treatment and research communications, 39:100809, 2024

39. Hirata T, Uehara Y, Hakozaki T, Kobayashi T, Terashima Y, Watanabe K, Yomota M, Hosomi Y. Brief Report: Clinical Outcomes by Infusion Timing of Immune Checkpoint Inhibitors in Patients With Locally Advanced NSCLC. JTO clinical and research reports, 5:100659, 2024

40. Niho S, Sato J, Satouchi M, Itoh S, Okuma Y, Mizugaki H, Murakami H, Fujisaka Y, Kozuki T, Nakamura K, Machida R, Ohe Y, Tamai T, Ikezawa H, Yamamoto N. Long-term follow-up and exploratory analysis of lenvatinib in patients with metastatic or recurrent thymic carcinoma: Results from the multicenter, phase 2 REMORA trial. Lung cancer (Amsterdam, Netherlands), 191:107557, 2024

41. 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

42. Tamura K, Okuma Y, Nomura S, Fukuda A, Masuda K, Matsumoto Y, Shinno Y, Yoshida T, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Efficacy and safety of chemoimmunotherapy in advanced non-small cell lung cancer patients with antibiotics-induced dysbiosis: a propensity-matched real-world analysis. Journal of cancer research and clinical oncology, 150:216, 2024

43. Okamoto K, Hijioka S, Nagashio Y, Okada M, Ohba A, Maruki Y, Kondo S, Morizane C, Ueno H, Okusaka T. Immune-related adverse event-associated sclerosing cholangitis due to immune checkpoint inhibitors: imaging findings and treatments. Japanese journal of clinical oncology, 54:887-894, 2024

44. 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

45. 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

46. Tanaka T, Goto Y, Masuda K, Shinno Y, Matsumoto Y, Okuma Y, Yoshida T, Horinouchi H, Yamamoto N, Ohe Y. The remarkable antitumor efficacy of corticosteroid treatment in patients with refractory thymomas. Respiratory investigation, 62:766-772, 2024

47. Yamamoto N, Kitano S, Koyama T, Ikeda M, Mizugaki H, Narikiyo T, Yamaguchi Y, Ishida T, Takubo R, Ogami C, Sekiya M, Nakagawa Y, Kuboki Y. Phase I study of the safety and clinical activity of the interleukin-8 inhibitor AMY109 combined with atezolizumab in patients with advanced solid cancers. Journal for immunotherapy of cancer, 12:e009262, 2024

48. Murata S, Horinouchi H, Morishita M, Kaku S, Shinno Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Kashihara T, Okuma K, Kusumoto M, Ohe Y. Impact of Durvalumab on the Duration and Complexity of Corticosteroid Therapy for Pneumonitis After Chemoradiotherapy. Clinical lung cancer, 25:e369-e378.e3, 2024

49. Uehara Y, Kato S, Nishizaki D, Miyashita H, Lee S, Nesline MK, Pabla S, Conroy JM, DePietro P, Ko H, Sicklick JK, Kurzrock R. 4-1BB transcriptomic expression patterns across malignancies: Implications for clinical trials of 4-1BB agonists. Cancer communications (London, England), 44:1168-1172, 2024

50. Koyama T, Yonemori K, Shimizu T, Sato J, Kondo S, Sudo K, Yoshida T, Katsuya Y, Imaizumi T, Enomoto M, Seki R, Yamamoto N. Phase I Study of Simlukafusp Alfa (FAP-IL2v) with or without Atezolizumab in Japanese Patients with Advanced Solid Tumors. Cancer research communications, 4:2349-2358, 2024

51. Takeshita K, Hijioka S, Nagashio Y, Hara H, Agarie D, Kawasaki Y, Takasaki T, Yagi S, Hagiwara Y, Okamoto K, Yamashige D, Fukuda S, Kuwada M, Komori Y, Okada M, Maruki Y, Morizane C, Ueno H, Yatabe Y, Okusaka T. Study Protocol for a Prospective Self-Controlled Trial on Success in Meeting Comprehensive Genomic Profiling Analysis Criteria for Specimens Obtained by Endoscopic Ultrasound-Guided Tissue Acquisition Using a 19G Needle from Primary and Metastatic Lesions in Pancreatic Cancer with Metastatic Lesions: The PRIMATE Study. Diseases (Basel, Switzerland), 12:182, 2024

52. Shen X, Xie J, Liu S, Cai Y, Yuan S, Uehara Y, Zhu D, Zheng M. Anoikis-related subtype and prognosis analyses based on bioinformatics, and an expression verification of ANGPTL4 based on experiments of lung adenocarcinoma. Journal of thoracic disease, 16:5361-5378, 2024

53. Penkov K, Bondarenko I, Saenko DV, Kulyaba Y, Guo J, Gong Y, Yamamoto N, Hotko YS, Boyko V, Fadeeva NV, Ursol GM, Ahn HK, Kislov NV, Shen CI, Davis C, Kowalski K, Michelon E, Pavlov D, Hirohashi T, Cho BC. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. Therapeutic advances in medical oncology, 16:17588359241274592, 2024

54. Igawa Y, Yoshida T, Makihara R, Torasawa M, Tateishi A, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Association between lorlatinib blood concentration and adverse events and clinical impact of dose modification. Lung cancer (Amsterdam, Netherlands), 196:107954, 2024

55. Sato J, Sadachi R, Koyama T, Katsuya Y, Okada M, Yamamoto N. Regional diversity in drug-induced lung diseases among the USA, European Union, and Japan. Frontiers in medicine, 11:1390083, 2024

56. Oshima T, Yamamoto S, Kawakami H, Makino T, Kawazoe A, Masuishi T, Tsushima T, Hirao M, Tsuda M, Hino K, Yamamoto N, Hara H, Kaname S, Matsuoka D, Otake Y, Yasuda K, Takase T, Takashima S, Semba T, Ooki A. Phase 1b/2 study of the liposomal formulation of eribulin (E7389-LF) in combination with nivolumab: Results from the phase 2 esophageal cancer cohort. BJC reports, 2:66, 2024

57. Tateishi A, Okuma Y, Goto Y, Arakaki M, Igawa YS, Torasawa M, Shinno Y, Yoshida T, Horinouchi H, Yamamoto N, Ohe Y. Key Therapeutic Agents for Thymic Carcinoma in Real-world Clinical Practice. Anticancer research, 44:5501-5513, 2024

58. Satake T, Morizane C, Okada M, Nishioka M, Hiraoka N, Nara S, Kakegawa T, Kobayashi M, Koyama K, Esaki M, Okusaka T. Prevalence of HER3 Expression in Pancreatic Cancer Patients Treated With Systemic Chemotherapy. Cancer medicine, 13:e70474, 2024

59. Baba S, Kawasaki T, Hirano S, Nakamura T, Asano T, Okazaki R, Yoshida K, Kawase T, Kurahara H, Oi H, Yokoyama M, Kita J, Imura J, Kinoshita K, Kondo S, Okada M, Satake T, Igawa YS, Yoshida T, Yamaguchi H, Ando Y, Mizunuma M, Ichikawa Y, Hida K, Nishihara H, Kato Y. A noninvasive urinary microRNA-based assay for the detection of pancreatic cancer from early to late stages: a case control study. EClinicalMedicine, 78:102936, 2024

60. Uehara Y, Takeyasu Y, Yoshida T, Tateishi A, Torasawa M, Hosomi Y, Masuda K, Shinno Y, Matsumoto Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Ohe Y. Real-world outcomes of treatment strategy between first-line osimertinib, first/second-generation EGFR-TKIs followed by osimertinib and without osimertinib in advanced EGFR-mutant NSCLC. ESMO Real World Data and Digital Oncology, 5:100058, 2024

61. Uehara Y, Tan A. The Butterfly effect—will the MARIPOSA-2 study alter the trajectory of EGFR mutated non-small cell lung cancer (NSCLC). AME Clinical Trials Review, North America, 2:33, 2024