95P - Additional survival follow-up of TACTICS-L: Transcatheter arterial chemoembolization therapy (TACE) in combination strategy with lenvatinib in (LEN) patients with unresectable hepatocellular carcinoma in Japan

Background

TACTICS-L is a prospective study to evaluate safety and efficacy of combination of TACE and LEN in HCC patients who are not eligible for curative therapy (uHCC). The primary analysis was conducted at cutoff date of April 2021 (minimum follow-up 12 months), and median progression-free survival (PFS), the primary endpoint, was 24.4 months. Regarding the secondary endpoint, the median overall survival (OS) was 25.9 months, and best objective response was 88.7% (CR 67.7%) ¹⁾. Here we report an additional follow-up on PFS and OS.

Methods

TACTICS-L is prospective, multicenter, single-arm phase II study. LEN was administered orally once daily for 14 to 21 days prior to TACE at a dose of 12 mg (body weight ≥60 kg) or 8 mg (<60 kg). The first TACE was performed after a 2-day LEN interruption. This combination therapy was repeated until time to untreatable progression. The primary endpoint was PFS. Secondary endpoints included TTUP, ORR, OS, and safety. The additional follow-up was conducted 12-months after the cutoff date of the primary analysis.

Results

Between February 2019 and April 2020, 62 patients were enrolled from 19 sites. Median age was 72.0 years. Number of patients with Child-Pugh score 5 and 6 was 51 (82.3%) and 11 (17.7%); ECOG-PS 0 and 1 was 59 (95.2%) and 3 (4.8%). The number of previous TACE was 0 in 35 patients (56.5%) and 1 to 3 in 27 patients (43.5%). The cutoff date of an additional follow-up was April 2022 (minimum follow-up 24 months). Median PFS and OS were 28.3 months (90% Cl; 21.3, 31.0) and Not Reached (90% Cl; 35.5, -). In order to examine the characteristics of patients with CR and non-CR, we also performed sub-group analyses, including Up to 7 criteria, BCLC Staging, macroscopic classification, tumor diameter and number at baseline. The characteristics between patients with CR and non-CR was similar.

Conclusions

In this additional follow-up, the combination of TACE and LEN continued to show promising therapeutic efficacy in PFS, OS and tumor response for uHCC patients, and consistent with the primary analysis.

Clinical trial identification

jRCTs031180074.

Editorial acknowledgement

Legal entity responsible for the study

Masatoshi Kudo.

Funding

Eisai., Co, Ltd.

Disclosure

K. Ueshima: Financial Interests, Personal, Advisory Role: Eisai, Lilly Japan, Pfizer, Chugai Pharma, Takeda; Financial Interests, Personal, Invited Speaker: Bayer, Eisai, Lilly Japan, Chugai Pharma, Takeda, MSD, EA Pharma, Sumitomo Group, Taiho Pharmaceutical, Kowa. N. Morimoto: Financial Interests, Personal, Research Grant: Eisai, AbbVie. H. Aikata: Financial Interests, Personal, Invited Speaker: Eisai; Financial Interests, Personal, Research Grant: Eisai. M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, Ono, Takeda, GlaxoSmithKline; Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, NIHON SERVIER, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, 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, Novartis, Takeda, J-Pharma, Pfizer, Chiome Bioscience, NIHON Servier, Delta-Fly Pharma, Syneos Health, Merus.N.V. M. Moriguchi: Financial Interests, Personal, Invited Speaker: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.; Financial Interests, Personal, Advisory Board: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Funding: MSD K.K. Eisai Co., Ltd., Bristol Myers Squibb K.K., Bayer Yakuhin, Ltd. Y. Kawamura: Financial Interests, Personal, Invited Speaker: Eisai, Chugai Pharma, Terumo. K. Yoshimura: Financial Interests, Personal, Advisory Role: Nippon Shinyaku, Brightpatheraputics; Financial Interests, Personal, Invited Speaker: Chugai Pharma, Lilly, Astra Zeneca, Taiho Pharmaceutical, Boehringer Ingelheim, Takeda, Eisai, Novartis, Otsuka, Nihonkayaku. M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Liiy, Bayer, Takeda, MSD; Financial Interests, Institutional, Research Grant: Otsuka, Sumitomo Dainippon Pharma, EA Pharma, Taiho, Eisai, AbbVie, Gilead Sciences, Takeda, GE Healthcare, Chugai. All other authors have declared no conflicts of interest.