Annual Report 2021
Department of Experimental Therapeutics
Noboru Yamamoto, Toshio Shimizu, Kan Yonemori, Satoru Iwasa, Shunsuke Kondo, Tatsuya Yoshida, Kazuki Sudo, Takafumi Koyama, Yuki Katsuya, Takaaki Mizuno
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 evaluation 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 & medical oncology, gastro-intestinal oncology, hepato-biliary & pancreatic oncology, and immuno-oncology).
The Team and What We Do
This department plays a key role in the development of new anti-cancer drugs in Asia as well as in Japan. The top priority is to conduct FIH trials, and we also perform phase I trials for solid tumors (i.e., all comers). Recently, we have joined in with global phase I trials to accelerate the development of new drugs in Japan. Web or telephone conferences are held with the EU and US sites, and we have been discussing patient enrollment and further developmental strategies. Routine web conferences are also held between the NCC-Hospital (Tokyo) and NCC-East Hospital (Chiba) every Friday morning, and we share information about adverse events and patient enrollment and refer candidates to each other to accelerate enrollment. Nowadays, most of the phase I trials in Japan (i.e., first-in-Japan phase I trials and first-in-human trials) are conducted at NCC-Hospital and NCC-East Hospital through firm collaboration.
Research activities
Elucidation of the proof of concept (POC) is essential in the development of new anti-cancer drugs especially in the early phases, so we conduct several translational research (TR) projects in collaboration with research institutes. Also, we conduct 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 was launched in 2018.
Clinical trials
In fiscal 2021, 97 phase I trials were conducted, including 50 FIH trials.
Education
In 2021, the 3rd NCCH & RI Tsukiji TR Board Activity Web was held on November 17 at the NCC-Tsukiji campus.
List of papers published in 2021
Journal
1. Ebata T, Yamashita S, Takeshima H, Yoshida H, Kawata Y, Kino N, Yasugi T, Terao Y, Yonemori K, Kato T, Ushijima T. DNA methylation marker to estimate ovarian cancer cell fraction. Med Oncol, 39:78, 2022
2. Hironaka S, Sadachi R, Machida N, Iwasa S, Yamada Y, Sasako M, Yoshikawa T, Boku N, Terashima M. Association of renal function with the safety and efficacy of cisplatin plus S-1 therapy and docetaxel plus cisplatin plus S-1 therapy in patients with advanced gastric cancer: an exploratory analysis of JCOG1013. Japanese journal of clinical oncology, 52:14-23, 2022
3. Shirasawa M, Yoshida T, Imabayashi T, Okuma K, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Tsuchida T, Yamamoto N, Nakayama Y, Watanabe SI, Motoi N, Ohe Y. Baseline PD-L1 expression and tumour-infiltrated lymphocyte status predict the efficacy of durvalumab consolidation therapy after chemoradiotherapy in unresectable locally advanced patients with non-small-cell lung cancer. European journal of cancer (Oxford, England: 1990), 162:1-10, 2022
4. 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
5. Tateishi A, Horinouchi H, Yoshida T, Masuda K, Jo H, Shinno Y, Okuma Y, Goto Y, Yamamoto N, Ohe Y. Correlation between body mass index and efficacy of anti-PD-1 inhibitor in patients with non-small cell lung cancer. Respiratory investigation, 60:234-240, 2022
6. Takumida H, Horinouchi H, Masuda K, Shinno Y, Okuma Y, Yoshida T, Goto Y, Yamamoto N, Ohe Y. Comparison of time to failure of pembrolizumab plus chemotherapy versus pembrolizumab monotherapy: a consecutive analysis of patients having NSCLC with high PD-L1 expression. Cancer immunology, immunotherapy: CII, 71:737-746, 2022
7. Jo H, Yoshida T, Horinouchi H, Yagishita S, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Yamamoto N, Takahashi K, Motoi N, Ohe Y. Prognostic significance of cachexia in advanced non-small cell lung cancer patients treated with pembrolizumab. Cancer immunology, immunotherapy: CII, 71:387-398, 2022
8. Goto Y, Arakawa S, Shirasawa M, Higashiyama R, Baba K, Masuda K, Shinno Y, Matsumoto Y, Okuma Y, Yoshida T, Horinouchi H, Yamamoto N, Ohe Y. Performance of Japanese patients in registrational studies. Japanese journal of clinical oncology, 52:53-64, 2022
9. Shibayama T, Shimoi T, Mori T, Noguchi E, Honma Y, Hijioka S, Yoshida M, Ogawa C, Yonemori K, Yatabe Y, Yoshida A. Cytokeratin-positive Malignant Tumor in the Abdomen With EWSR1/FUS-CREB Fusion: A Clinicopathologic Study of 8 Cases. The American journal of surgical pathology, 46:134-146, 2022
10. Yoshida A, Arai Y, Satomi K, Kubo T, Ryo E, Matsushita Y, Hama N, Sudo K, Komiyama M, Yatabe Y, Shibata T, Ichikawa H, Ichimura K, Kawai A, Mori T. Identification of novel SSX1 fusions in synovial sarcoma. Modern pathology: an official journal of the United States and Canadian Academy of Pathology, Inc, 35:228-239, 2022
11. Stein EM, DeAngelo DJ, Chromik J, Chatterjee M, Bauer S, Lin CC, Suarez C, de Vos F, Steeghs N, Cassier PA, Tai D, Kiladjian JJ, Yamamoto N, Mous R, Esteve J, Minami H, Ferretti S, Guerreiro N, Meille C, Radhakrishnan R, Pereira B, Mariconti L, Halilovic E, Fabre C, Carpio C . Results from a First-in-Human Phase I Study of Siremadlin (HDM201) in Patients with Advanced Wild-Type TP53 Solid Tumors and Acute Leukemia. Clinical cancer research: an official journal of the American Association for Cancer Research, 28:870-881, 2022
12. Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D . Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. The New England journal of medicine, 386:437-448, 2022
13. Rottey S, Clarke J, Aung K, Machiels JP, Markman B, Heinhuis KM, Millward M, Lolkema M, Patel SP, de Souza P, Duca M, Curigliano G, Santoro A, Koyama T, Brown M, Vezina H, He C, Chu QS. Phase I/IIa Trial of BMS-986148, an Anti-mesothelin Antibody-drug Conjugate, Alone or in Combination with Nivolumab in Patients with Advanced Solid Tumors. Clinical cancer research: an official journal of the American Association for Cancer Research, 28:95-105, 2022
14. 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: an official journal of the American Association for Cancer Research, 28:1783-1791, 2022
15. Takamizawa S, Shimoi T, Satomi-Tsushita N, Yazaki S, Okuya T, Kojima Y, Sumiyoshi-Okuma H, Nishikawa T, Tanioka M, Sudo K, Noguchi E, Yonemori K. Neutrophil-to-lymphocyte ratio as a prognostic factor for patients with metastatic or recurrent breast cancer treated using capecitabine: a retrospective study. BMC cancer, 22:64, 2022
16. Mizuno T, Yoshida T, Sunami K, Koyama T, Okita N, Kubo T, Sudo K, Shimoi T, Ueno H, Saito E, Katanoda K, Shibata T, Yonemori K, Okusaka T, Boku N, Ohe Y, Hiroshima Y, Ueno M, Kuboki Y, Doi T, Nakamura K, Kohno T, Yatabe Y, Yamamoto N. Study protocol for NCCH1908 (UPFRONT-trial): a prospective clinical trial to evaluate the feasibility and utility of comprehensive genomic profiling prior to the initial systemic treatment in advanced solid tumour patients. Japanese journal of clinical oncology, 51:1757-1760, 2021
17. Yazaki S, Yoshida T, Kojima Y, Yagishita S, Nakahama H, Okinaka K, Matsushita H, Shiotsuka M, Kobayashi O, Iwata S, Narita Y, Ohba A, Takahashi M, Iwasa S, Kobayashi K, Ohe Y, Yoshida T, Hamada A, Doi T, Yamamoto N. Difference in SARS-CoV-2 Antibody Status Between Patients With Cancer and Health Care Workers During the COVID-19 Pandemic in Japan. JAMA oncology, 7:1141-1148, 2021
18. Shirasawa M, Yoshida T, Shimoda Y, Takayanagi D, Shiraishi K, Kubo T, Mitani S, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Ichikawa H, Kohno T, Yamamoto N, Matsumoto S, Goto K, Watanabe SI, Ohe Y, Motoi N. Differential Immune-Related Microenvironment Determines Programmed Cell Death Protein-1/Programmed Death-Ligand 1 Blockade Efficacy in Patients With Advanced NSCLC. Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer, 16:2078-2090, 2021
19. Shimoda Y, Yoshida T, Shirasawa M, Mizuno T, Jo H, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Yatabe Y, Ohe Y, Motoi N. Smoking History Predicts High Presence of TILs and Efficacy of PD-1 Blockade in PD-L1 Expression-negative Non-small Cell Lung Cancer Patients. Anticancer research, 41:5739-5747, 2021
20. Hasegawa N, Kohsaka S, Kurokawa K, Shinno Y, Takeda Nakamura I, Ueno T, Kojima S, Kawazu M, Suehara Y, Ishijima M, Goto Y, Kojima Y, Yonemori K, Hayashi T, Saito T, Shukuya T, Takahashi F, Takahashi K, Mano H. Highly sensitive fusion detection using plasma cell-free RNA in non-small-cell lung cancers. Cancer science, 112:4393-4403, 2021
21. Morita C, Yoshida T, Shirasawa M, Masuda K, Matsumoto Y, Shinno Y, Yagishita S, Okuma Y, Goto Y, Horinouchi H, Yamamoto N, Motoi N, Yatabe Y, Ohe Y. Clinical characteristics of advanced non-small cell lung cancer patients with EGFR exon 20 insertions. Scientific reports, 11:18762, 2021
22. Satoh T, Kato K, Ura T, Hamamoto Y, Kojima T, Tsushima T, Hironaka S, Hara H, Iwasa S, Muro K, Yasui H, Minashi K, Yamaguchi K, Ohtsu A, Doki Y, Matsumura Y, Kitagawa Y. Five-year follow-up of nivolumab treatment in Japanese patients with esophageal squamous-cell carcinoma (ATTRACTION-1/ONO-4538-07). Esophagus: official journal of the Japan Esophageal Society, 18:835-843, 2021
23. Ishikawa M, Takashima A, Nagata Y, Sawada R, Aoki M, Imazeki H, Hirano H, Shoji H, Honma Y, Iwasa S, Okita N, Kato K, Saruta M, Boku N. Tumor growth rate during re-challenge chemotherapy with previously used agents as salvage treatment for metastatic colorectal cancer: A retrospective study. PloS one, 16:e0257551, 2021
24. Okuma HS, Yonemori K, Kojima Y, Tanioka M, Sudo K, Noguchi E, Hijioka S, Wakakuwa K, Kato K, Hirakawa A, Kuchiba A, Kubo T, Ichikawa H, Yoshida A, Yatabe Y, Nakamura K, Mano H, Yamamoto N, Fujiwara Y. Clinical Utility of Circulating Tumor DNA in Advanced Rare Cancers. Frontiers in oncology, 11:732525, 2021
25. Shimoi T, Hashimoto J, Sudo K, Shimomura A, Noguchi E, Shimizu C, Yunokawa M, Yonemori K, Yoshida H, Yoshida M, Kato T, Kinoshita T, Fukuda T, Fujiwara Y, Tamura K. Hotspot mutation profiles of AKT1 in Asian women with breast and endometrial cancers. BMC cancer, 21:1131, 2021
26. Kawai A, Naka N, Shimomura A, Takahashi S, Kitano S, Imura Y, Yonemori K, Nakatani F, Iwata S, Kobayashi E, Outani H, Tamiya H, Naito Y, Yamamoto N, Doi T. Efficacy and safety of TAS-115, a novel oral multi-kinase inhibitor, in osteosarcoma: an expansion cohort of a phase I study. Investigational new drugs, 39:1559-1567, 2021
27. Hibino Y, Ito M, Satake T, Kondo S. Clinical benefits of precision medicine in treating solid cancers: European Society of Medical Oncology-Magnitude of Clinical Benefit Scale score-based analysis. ESMO open, 6:100187, 2021
28. Iwasa S, Muro K, Morita S, Park YS, Nakamura M, Kotaka M, Nishina T, Matsuoka H, Ahn JB, Lee KW, Hong YS, Han SW, Cho SH, Zhang DS, Fang WJ, Bai L, Yuan XL, Yuan Y, Yamada Y, Sakamoto J, Kim TW. Impact of UGT1A1 genotype on the efficacy and safety of irinotecan-based chemotherapy in metastatic colorectal cancer. Cancer science, 112:4669-4678, 2021
29. Lin CC, Doi T, Muro K, Hou MM, Esaki T, Hara H, Chung HC, Helwig C, Dussault I, Osada M, Kondo S. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGFβ and PD-L1, in Patients with Esophageal Squamous Cell Carcinoma: Results from a Phase 1 Cohort in Asia. Targeted oncology, 16:447-459, 2021
30. Minami H, Kiyota N, Kimbara S, Ando Y, Shimokata T, Ohtsu A, Fuse N, Kuboki Y, Shimizu T, Yamamoto N, Nishio K, Kawakami Y, Nihira SI, Sase K, Nonaka T, Takahashi H, Komori Y, Kiyohara K. Guidelines for clinical evaluation of anti-cancer drugs. Cancer science, 112:2563-2577, 2021
31. Monk BJ, Colombo N, Oza AM, Fujiwara K, Birrer MJ, Randall L, Poddubskaya EV, Scambia G, Shparyk YV, Lim MC, Bhoola SM, Sohn J, Yonemori K, Stewart RA, Zhang X, Perkins Smith J, Linn C, Ledermann JA. Chemotherapy with or without avelumab followed by avelumab maintenance versus chemotherapy alone in patients with previously untreated epithelial ovarian cancer (JAVELIN Ovarian 100): an open-label, randomised, phase 3 trial. The Lancet. Oncology, 22:1275-1289, 2021
32. Nakamura IT, Kohsaka S, Ikegami M, Ikeuchi H, Ueno T, Li K, Beyett TS, Koyama T, Shimizu T, Yamamoto N, Takahashi F, Takahashi K, Eck MJ, Mano H. Comprehensive functional evaluation of variants of fibroblast growth factor receptor genes in cancer. NPJ precision oncology, 5:66, 2021
33. Oishi T, Sasaki Y, Tong Y, Chen L, Onodera T, Iwasa S, Udo E, Furusato B, Fujimori H, Imamichi S, Honda T, Bessho T, Fukuoka J, Ashizawa K, Yanagihara K, Nakao K, Yamada Y, Hiraoka N, Masutani M. A newly established monoclonal antibody against ERCC1 detects major isoforms of ERCC1 in gastric cancer. Global health & medicine, 3:226-235, 2021
34. Ou SI, Fujiwara Y, Shaw AT, Yamamoto N, Nakagawa K, Fan F, Hao Y, Gao Y, Jänne PA, Seto T . Efficacy of Taletrectinib (AB-106/DS-6051b) in ROS1+ NSCLC: An Updated Pooled Analysis of U.S. and Japan Phase 1 Studies. JTO clinical and research reports, 2:100108, 2021
35. Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, Richardson GE, Sessa C, Yonemori K, Banerjee S, Leary A, Tinker AV, Jung KH, Madry R, Park SY, Anderson CK, Zohren F, Stewart RA, Wei C, Dychter SS, Monk BJ. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. The Lancet. Oncology, 22:1034-1046, 2021
36. Saito A, Yoshida H, Nishikawa T, Yonemori K. Human epidermal growth factor receptor 2 targeted therapy in endometrial cancer: Clinical and pathological perspectives. World journal of clinical oncology, 12:868-881, 2021
37. Shimizu T, Fujiwara Y, Yonemori K, Koyama T, Sato J, Tamura K, Shimomura A, Ikezawa H, Nomoto M, Furuuchi K, Nakajima R, Miura T, Yamamoto N. First-in-Human Phase 1 Study of MORAb-202, an Antibody-Drug Conjugate Comprising Farletuzumab Linked to Eribulin Mesylate, in Patients with Folate Receptor-α-Positive Advanced Solid Tumors. Clinical cancer research: an official journal of the American Association for Cancer Research, 27:3905-3915, 2021
38. Shimoi T, Noguchi E, Sudo K, Chua YJ, Yonemori K. Critical Appraisal of Adjuvant Platinum-Based Chemotherapy for Basal Subtype Triple-Negative Breast Cancer With Residual Disease After Neoadjuvant Chemotherapy. Journal of clinical oncology: official journal of the American Society of Clinical Oncology, 39:3519-3521, 2021
39. Sunami K, Bando H, Yatabe Y, Naito Y, Takahashi H, Tsuchihara K, Toyooka S, Mimori K, Kohsaka S, Uetake H, Kinoshita I, Komine K, Takeda M, Hayashida T, Tamura K, Nishio K, Yamamoto N. Appropriate use of cancer comprehensive genome profiling assay using circulating tumor DNA. Cancer science, 112:3911-3917, 2021
40. Suzuki M, Yagishita S, Sugihara K, Ogitani Y, Nishikawa T, Ohuchi M, Teishikata T, Jikoh T, Yatabe Y, Yonemori K, Tamura K, Hasegawa K, Hamada A. Visualization of Intratumor Pharmacokinetics of [fam-] Trastuzumab Deruxtecan (DS-8201a) in HER2 Heterogeneous Model Using Phosphor-integrated Dots Imaging Analysis. Clinical cancer research: an official journal of the American Association for Cancer Research, 27:3970-3979, 2021
41. Takahashi S, Karayama M, Takahashi M, Watanabe J, Minami H, Yamamoto N, Kinoshita I, Lin CC, Im YH, Achiwa I, Kamiyama E, Okuda Y, Lee C, Bang YJ. Pharmacokinetics, Safety, and Efficacy of Trastuzumab Deruxtecan with Concomitant Ritonavir or Itraconazole in Patients with HER2-Expressing Advanced Solid Tumors. Clinical cancer research: an official journal of the American Association for Cancer Research, 27:5771-5780, 2021
42. Takeyasu Y, Yoshida T, Motoi N, Teishikata T, Tanaka M, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Kakishima H, Tsuchida T, Yamamoto N, Ohe Y, Yatabe Y. Corrigendum to: Feasibility of next-generation sequencing (Oncomine DX Target Test) for the screening of oncogenic mutations in advanced non-small-cell lung cancer patients. Japanese journal of clinical oncology, 51:1183, 2021
43. Uchihara M, Tanioka M, Kojima Y, Nishikawa T, Sudo K, Shimoi T, Noguchi E, Maeshima AM, Yonemori K. Clinical management and outcomes associated with etoposide, doxorubicin, and cisplatin plus mitotane treatment in metastatic adrenocortical carcinoma: a single institute experience. International journal of clinical oncology, 26:2275-2281, 2021
44. Yap TA, Vieito M, Baldini C, Sepúlveda-SÁnchez JM, Kondo S, Simonelli M, Cosman R, van der Westhuizen A, Atkinson V, Carpentier AF, Löhr M, Redman R, Mason W, Cervantes A, Le Rhun E, Ochsenreither S, Warren L, Zhao Y, Callies S, Estrem ST, Man M, Gandhi L, Avsar E, Melisi D . First-In-Human Phase I Study of a Next-Generation, Oral, TGFβ Receptor 1 Inhibitor, LY3200882, in Patients with Advanced Cancer. Clinical cancer research: an official journal of the American Association for Cancer Research, 27:6666-6676, 2021
45. Shirasawa M, Yoshida T, Takayanagi D, Shiraishi K, Yagishita S, Sekine K, Kanda S, Matsumoto Y, Masuda K, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Hamada A, Kohno T, Yamamoto N, Watanabe SI, Ohe Y, Motoi N. Activity and Immune Correlates of Programmed Death-1 Blockade Therapy in Patients With Advanced Large Cell Neuroendocrine Carcinoma. Clinical lung cancer, 22:282-291.e6, 2021
46. Takeyasu Y, Yoshida T, Motoi N, Teishikata T, Tanaka M, Matsumoto Y, Shinno Y, Okuma Y, Goto Y, Horinouchi H, Kakishima H, Tsuchida T, Yamamoto N, Ohe Y, Yatabe Y. Feasibility of next-generation sequencing (Oncomine DX Target Test) for the screening of oncogenic mutations in advanced non-small-cell lung cancer patients. Japanese journal of clinical oncology, 51:1114-1122, 2021
47. Takeyasu Y, Okuma HS, Kojima Y, Nishikawa T, Tanioka M, Sudo K, Shimoi T, Noguchi E, Arakawa A, Mori T, Sunami K, Kubo T, Kohno T, Akihiko Y, Yamamoto N, Yonemori K. Impact of ALK Inhibitors in Patients With ALK-Rearranged Nonlung Solid Tumors. JCO precision oncology, 5:2021
48. Shimizu T, Kim DW, Loong HH, Lin CC, Ng MC, Yamamoto N, Ma B, Tan DS. Overcoming the impact of the COVID-19 pandemic on oncology early phase trials and drug development in Asia-Experiences and perspectives of the Asian Oncology Early Phase 1 Consortium. Asia-Pacific journal of clinical oncology, 17:388-395, 2021
49. Harding JJ, Moreno V, Bang YJ, Hong MH, Patnaik A, Trigo J, Szpurka AM, Yamamoto N, Doi T, Fu S, Calderon B, Velez de Mendizabal N, Calvo E, Yu D, Gandhi L, Liu ZT, Galvao VR, Leow CC, de Miguel MJ. Blocking TIM-3 in Treatment-refractory Advanced Solid Tumors: A Phase Ia/b Study of LY3321367 with or without an Anti-PD-L1 Antibody. Clinical cancer research: an official journal of the American Association for Cancer Research, 27:2168-2178, 2021
50. Yamamoto N, Shimizu T, Yonemori K, Kitano S, Kondo S, Iwasa S, Koyama T, Sudo K, Sato J, Tamura K, Tomomatsu J, Ono M, Fukuda N, Takahashi S. A first-in-human, phase 1 study of the NEDD8 activating enzyme E1 inhibitor TAS4464 in patients with advanced solid tumors. Investigational new drugs, 39:1036-1046, 2021
51. Kondo S, Shimizu T, Koyama T, Sato J, Iwasa S, Yonemori K, Fujiwara Y, Shimomura A, Kitano S, Tamura K, Yamamoto N. First-in-human study of the cancer peptide vaccine TAS0313 in patients with advanced solid tumors. Cancer science, 112:1514-1523, 2021
52. Yonemori K, Shimizu T, Kondo S, Iwasa S, Koyama T, Kitano S, Sato J, Shimomura A, Shibaki R, Suri A, Kase Y, Sumino S, Tamura K, Yamamoto N. The safety, tolerability and pharmacokinetics of niraparib in Japanese patients with solid tumours: results of a phase I dose-escalation study. Japanese journal of clinical oncology, 51:693-699, 2021
53. Takahashi S, Fujiwara Y, Nakano K, Shimizu T, Tomomatsu J, Koyama T, Ogura M, Tachibana M, Kakurai Y, Yamashita T, Sakajiri S, Yamamoto N. Safety and pharmacokinetics of milademetan, a MDM2 inhibitor, in Japanese patients with solid tumors: A phase I study. Cancer science, 112:2361-2370, 2021
54. Yoh K, Seto T, Satouchi M, Nishio M, Yamamoto N, Murakami H, Nogami N, Nosaki K, Kohno T, Tsuta K, Nomura S, Ikeno T, Wakabayashi M, Sato A, Matsumoto S, Goto K. Final survival results for the LURET phase II study of vandetanib in previously treated patients with RET-rearranged advanced non-small cell lung cancer. Lung cancer (Amsterdam, Netherlands), 155:40-45, 2021