148P - Safety and efficacy of atezolizumab (Atezo) + bevacizumab (Bev) in Japanese patients (pts) with unresectable hepatocellular carcinoma (uHCC): Preliminary analysis of a prospective, multicenter, observational study (ELIXIR)

Background

Atezo + Bev has been approved as first-line treatment in pts with uHCC based on a global phase 3 study (IMbrave 150). However, real-world data is lacking worldwide. Thus, we conducted the ELIXIR study to evaluate the safety and efficacy of Atezo + Bev prospectively in real-world Japanese pts. Here, we report the safety assessment and preliminary efficacy results in 493 pts out of 510 pts.

Methods

In this prospective, multicenter, observational study, 510 systemic treatment-naïve pts with uHCC and Child-Pugh A received Atezo 1200 mg IV q3w + Bev 15 mg/kg IV q3w. The primary endpoint was adverse events of special interest (AESI). Efficacy outcomes were also assessed, including progression-free survival (PFS) and objective response rate (ORR).

Results

A total of 510 pts were enrolled between Apr 2021 and Feb 2022. 493 pts were analyzed and the median follow-up time was 14.5 mo (95% CI, 13.8, 15.0). A total of 240 (48.7%) AESIs and 149 (30.2%) Grade ≥3 AESIs were observed (Table). Median PFS was 8.1 mo (95% CI, 7.4, 9.5) per RECIST 1.1 and 8.3 mo (95% CI, 7.5, 9.7) per modified RECIST (mRECIST). ORR was 28.6% (95% CI, 24.6, 32.8) per RECIST 1.1 and 36.5% (95% CI, 32.3, 40.9) per mRECIST. Table: 148P

Adverse events of special interest

Conclusions

In this analysis, as previously reported, additional safety signals were not observed in Japanese pts. The efficacy seen in ELIXIR was consistent with that of IMbrave150, and Atezo+Bev could be a standard first-line therapy for Japanese uHCC pts in the real world.

Clinical trial identification

UMIN00004346.

Editorial acknowledgement

Medical writing support was provided by Mark Snape, MBBS, CMPP, of inScience Communications, Springer Healthcare.

Legal entity responsible for the study

Chugai Pharmaceutical Co., Ltd.

Funding

Chugai Pharmaceutical Co., Ltd.

Disclosure

T. Kuzuya: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co. T. Yamashita: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Lilly, Bayer, Takeda; Financial Interests, Institutional, Local PI: Bristol Myers Squibb MSD, Ono, Abbie, Eisai; Financial Interests, Institutional, Other, Sub-PI: Chugai. T. Takehara: Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Institutional, Research Grant: Chugai. H. Aikata: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical CO., LTD., Eisai Co., Ltd. N. Kato: Financial Interests, Personal, Invited Speaker: Gilead Sciences Inc., AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Eisai Co., Ltd., Aska Pharmaceutical Co., Ltd., Tsumura & Co., Mochida Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Covidien Japan Inc., Eli Lilly Japan K.K., Nobelpharma Co., Ltd., Kowa Company, Ltd., Incyte Biosciences Japan GK, Yakult Honsha Co., Ltd., Olympus Marketing, Inc., Taisho Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Daiichi Sankyo Co., Ltd., Bayer Yakuhin Co., Ltd., EA Pharma Co., Ltd., Asahi Kasei Pharma Co., Ltd.; Financial Interests, Institutional, Research Grant: AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Shionogi & Co., Ltd., Eisai Co., Ltd., Tsumura & Co., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd., Kowa Company, Ltd. N. Morimoto: Financial Interests, Personal, Invited Speaker: Chugai Parma., AbbVie, Eisai; Financial Interests, Personal and Institutional, Research Grant: AbbVie, Eisai. M. Moriguchi: Financial Interests, Personal, Invited Speaker: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Takeda Pharmaceutical Company Limited; Financial Interests, Personal, Advisory Board: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., AztraZeneca K.K.; Financial Interests, Institutional, Funding: MSD K.K. Eisai Co., Ltd., Bristol Myers Squibb K.K., Bayer Yakuhin, Ltd., Eisai Co., Ltd. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, MSD; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, Takeda, Ono, MSD, Taisho Pharmaceutical, Nippon Kayaku, Guardant Health Japan; Financial Interests, Institutional, Coordinating PI: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, MSD, Ono, Novartis, J-Pharma, Pfizer, Chiome Bioscience, NIHON Servier, Delta-Fly Pharma, Syneos Health, Merus.N.V., Merck biopharma, Boehringer Ingelheim, Invitae; Financial Interests, Personal, Steering Committee Member: Chugai, NIHON Servier, Takeda, Novartis, Eisai, Rakuten Medical. Y. Ueno: Financial Interests, Personal, Invited Speaker: EA Pharma, Chugai, AbbVie. R. Tateishi: Financial Interests, Personal, Invited Speaker: AbbVie, EA Pharma, ASKA Pharmaceutical Co. Ltd., Incyte Japan, Eisai, Gilead Sciences, Covidien, Bayer, AstraZeneca, Sumitomo Pharma, Fujifilm Wako, Takeda Pharmaceutical, Chugai Pharmaceutical, Nobelpharma; Financial Interests, Personal, Coordinating PI: Cure App. Y. Kawamura: Financial Interests, Personal, Invited Speaker: Eisai Co., Ltd., Chugai Pharmaceutical Co., Ltd., Terumo Corporation.; Non-Financial Interests, Personal, Principal Investigator: Chugai Pharmaceutical Co., Eisai Co., Ltd. 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; 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; Financial Interests, Personal, Steering Committee Member: Merck Bio, Ono Pharmaceutical, MSD, Taiho Pharmaceutical, Astellas, AstraZeneca, Incyte Japan. M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Liiy, Bayer, Takeda, AstraZeneca; Financial Interests, Institutional, Research Grant: Otsuka, EA Pharma, Taiho, Eisai, AbbVie, GE Healthcare, Chugai. K. Yamamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, CMIC holdings, Johokiko, Triceps, Kanagawa Medical Practitioners Association, CM Plus Vietnam Co., Ltd.; Financial Interests, Personal, Other, Statistical consultation: J-Pharma, Craif, Kanagawa Prefectural Hospital Organization; Financial Interests, Institutional, Other, unlimited grant: Taiho Pharmaceutical; Financial Interests, Institutional, Other, Unlimited grant: Ono Pharmaceutical, Takeda Pharmaceutical, Bayer, Daiichi Sankyo, Kyowa Kirin, Data Vehicle Inc., EP Croit, Chugai Pharmaceutical, Otsuka Pharmaceutical; Financial Interests, Personal, Advisory Board: Delta Fly Farma, SRL Medisearch lnc., FUJIFILM Toyama Chemical Co., Ltd., Takeda Pharmaceutical Company Limited; Financial Interests, Personal, Writing Engagement: Tokyo Shoseki Co., Ltd. N. Kokudo: Financial Interests, Personal, Other, Steering committee member for a clinical trial.: AstraZeneca. All other authors have declared no conflicts of interest.