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Poster session 13

64P - Phase I/II study of nivolumab plus lenvatinib for advanced biliary tract cancer (JCOG1808/NCCH1817, SNIPE)

Date

10 Sep 2022

Session

Poster session 13

Topics

Tumour Site

Hepatobiliary Cancers

Presenters

Makoto Ueno

Citation

Annals of Oncology (2022) 33 (suppl_7): S19-S26. 10.1016/annonc/annonc1036

Authors

M. Ueno1, C. Morizane2, M. Ikeda3, M. Ozaka4, F. Nagashima5, T. Kataoka6, J. Mizusawa7, A. Ohba2, S. Kobayashi1, H. Imaoka3, A. Kasuga4, N. Okano5, Y. Nagasaka8, K. kurishita8, S. Tomatsuri8, M. Sasaki3, T. Shibata7, K. Nakamura6, J. Furuse1, T. Okusaka2

Author affiliations

  • 1 Gasteroenterology Dept, Kanagawa Cancer Center, 241-8515 - Yokohama/JP
  • 2 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center - Tsukiji Campus, 104-0045 - Tokyo/JP
  • 3 Department Of Hepatobiliary And Pancreatic Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP
  • 4 Gastroenterology Dept., The Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 5 Department Of Medical Oncology, Kyorin university Faculty of Medicine, 181-8611 - Tokyo/JP
  • 6 Japan Clinical Oncology Group Operations Office/clinical Research Support Office, National Cancer Center - Tsukiji Campus, 104-0045 - Tokyo/JP
  • 7 Japan Clinical Oncology Group Data Center, National Cancer Center - Tsukiji Campus, 104-0045 - Tokyo/JP
  • 8 Clinical Research Support Office, National Cancer Center - Tsukiji Campus, 104-0045 - Tokyo/JP
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Abstract 64P

Background

Although cisplatin plus gemcitabine and other cytotoxic chemotherapy combinations have improved the survival of advanced biliary tract cancer (BTC) patients (pts), high unmet medical needs remain for the treatment of BTC. Immune checkpoint inhibitors have shown limited efficacy in monotherapy for advanced BTC. Recently, combinations of them with other therapies have shown remarkable efficacy in multiple cancer types. This study aimed to assess the efficacy and safety of nivolumab plus lenvatinib in second-line treatment for advanced BTC.

Methods

The study included pts receiving second-line treatment for advanced BTC. Nivolumab (240 mg) was administered biweekly. Phase I was performed to determine the recommended phase II dose of lenvatinib (from 20 mg to 14 mg, daily). In phase II, the primary endpoint was the objective response rate (ORR). Secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. The planned sample size was 32 pts in phase II, which provided 80% power for the primary endpoint with a one-sided alpha error of 5%, threshold ORR of 10% and expected ORR of 30%. If efficacy was expected in phase II, we planned to initiate a first-line expansion cohort.

Results

The recommended dose of lenvatinib was determined to be 20 mg in the 6 pts in phase I with one DLT of myocarditis. In phase II, we enrolled 26 pts. ORR, DCR and median OS and PFS were 9.4% (90% CI 2.6-22.5), 53.1% (95% CI 34.7-70.9) and 6.4 (95% CI 4.9-9.7) and 2.5 (95% CI 1.5-4.1) months, respectively. The frequently reported grade 3-4 adverse events were hypertension (59.4%), biliary tract infection (18.8%), neutrophil count decreased (12.5%), and platelet count decreased (9.4%). Rash (28.1%), hypothyroidism (21.9%), fatigue (18.8%), fever (12.5%), anorexia (12.5%), ACTH increased (9.4%), diarrhea (9.4%), hyperthyroidism (6.3%), ALT increased (6.3%), mucositis oral (6.3%), atrial fibrillation (6.3%), and pneumonitis (6.3%) were observed as immune-mediated adverse events.

Conclusions

Nivolumab plus lenvatinib had a manageable safety profile in pts with advanced BTC. But the efficacy in second-line treatment was limited.

Clinical trial identification

JMA-IIA00436.

Editorial acknowledgement

Legal entity responsible for the study

National Cancer Center Hospital, Tokyo, Japan.

Funding

Ono Pharmaceutical, Eisai.

Disclosure

M. Ueno: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, AstraZeneca, MSD, Nihon Servier, Ono Pharmaceutical, Incyte, Chugai Pharmaceutical; Financial Interests, Personal, Advisory Board: Nippon Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Taiho Pharmaceutical, AstraZeneca, Merck Biopharma, MSD, Astellas Pharma, Eisai, Ono Pharmaceutical, Incyte, Chugai Pharmaceutical, DFP, Daiichi Sankyo. C. Morizane: Financial Interests, Personal, Advisory Board: Yakult, MSD, Servier, Boehringer Ingelheim, AstraZeneca, Taiho Pharmaceutical, Merck biopharma; Financial Interests, Personal, Invited Speaker: Novartis, Teijin Pharma; Financial Interests, Institutional, Invited Speaker: Yakult Honsha, Ono Pharmaceutical, Taiho Pharmaceutical, Eisai, MSD K.K., J-Pharma, AstraZeneca, Merck biopharma; Financial Interests, Institutional, Funding: Daiichi Sankyo RD Novare, Hitachi. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Chugai, Eli Lilly Japan, Eisai, MSD, Nihon Servier, Novartis, Ono, Takeda, GlaxoSmithKline; Financial Interests, Personal, Invited Speaker: AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Chugai, Eli Lilly Japan, Eisai, Nihon Servier, Novartis, Otsuka, Taiho, Yakult, Teijin Pharma, ASLAN, Chugai, Nihon Servier, Takeda; Financial Interests, Institutional, Invited Speaker: Bayer, Bristol-Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Merck Serono, MSD, Ono, Yakult, ASLAN, Novartis, Takeda, J-Pharma, Pfizer, Chiome Bioscience, GlaxoSmithKline, Nihon Servier, Delta-Fly Pharma. M. Ozaka: Financial Interests, Personal, Invited Speaker: Taiho, Yaklut, MSD, Incyte, Ono, Bayer. F. Nagashima: Financial Interests, Personal, Invited Speaker: Chugai Pharma, Takeda Pharma, Taiho Pharma, MSD; Financial Interests, Personal, Advisory Board: Yakult Honsha; Financial Interests, Institutional, Other, research fund: Yakult Honsha, Astellas Pharma, Eisai Co, MSD, ONO parma, J-Pharma Co; Financial Interests, Institutional, Other, Research fund: Daiichi Sankyo Company, Sumitomo Dainippon Pharma, Taiho Pharma, Takeda Pharma, Merck Biopharma, Mochida Pharma, Chugai Pharma. J. Mizusawa: Financial Interests, Personal, Other, Honoraria: Chugai pharmaceutical, Taiho pharmaceutical; Other, , Other, My spouse receives salary: Pfizer. A. Ohba: Financial Interests, Personal, Invited Speaker: Yakult, Ono, Servier, Taiho; Financial Interests, Institutional, Invited Speaker: Ono, Chugai. H. Imaoka: Financial Interests, Personal, Research Grant: Ono Pharmaceutical. N. Okano: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Eli Lilly Japan, Eisai, Bayer Yakuhin, Chugai, Ono Pharmaceutical, Takeda; Financial Interests, Personal, Advisory Board: GlaxoSmithKline. J. Furuse: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical, Bayer, Eisai, Eli Lilly Japan, MSD, Yakult Honsha, Chugai Pharma, Novartis Pharma, AstraZeneca, Pfizer, Takeda, Taiho Pharmaceutical, Sannofy, Mylan EPD, EA Pharma, Kyowa Hakko Kirin, Daiichi Sankyo, Teijin pharma, Servier Japan, Incy, Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Astellas, AstraZeneca, Incyte Japan; Financial Interests, Personal, Advisory Board: Fuji film, Mudi Pharma, Onco Therapy Science, Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Chugai Pharma, Astellas, AstraZeneca, Takara bio, Delta-Fly-Pharma, Incyte Japan; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical, MSD, Merck Bio, J-Pharma, Taiho Pharmaceutical, Takeda, Chugai Pharma, AstraZeneca, Yakult Honsha, Eisai, Daiichi Sankyo, Mochida, Sanofy, Sumitomo Dainippon Bayer, Astellas, Incyte Japan. T. Okusaka: Financial Interests, Personal, Advisory Board: Daiichi-sankyo, Eisai, Nihon Servier, AstraZeneca, Incyte, Ono Pharmaceutical, FUJIFILM Toyama Chemical, Chugai Pharma; Financial Interests, Personal, Invited Speaker: AstraZeneca, Eisai, Ono Pharmaceutical, Yakut Honsha, Chugai Pharma, Eli lilly, Nihon Servier, Incyte, Johnson & Johnson, Bristol-Myers Squibb, AstraZeneca; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Chugai Pharma, Eisai, Novartis, Bristol-Myers Squibb, MSD, Dainippon Sumitomo Pharma, Incyte. All other authors have declared no conflicts of interest.

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