317P - A project to investigate the actual status of biomarker testing in unresectable advanced or recurrent non-small cell lung cancer: WJOG15421 L (REVEAL)

Background

The biomarker testing to detect driver-mutations has been essential for selecting adequate treatment in non-small cell lung cancer (NSCLC). However, there are a certain number of patients with advanced or recurrent NSCLC in whom driver genes have not been sufficiently searched for before initial treatment. The purpose of this study was to investigate the actual status of biomarker testing and drug therapy, and to identify the problems in lung cancer treatment in the real-world setting.

Methods

This retrospective, multicenter study registered patients with advanced or recurrent NSCLC diagnosed between July 1, 2020 and June 30, 2021, in Japan. The primary endpoint was the actual status of biomarker testing. Treatment-related factors were also examined.

Results

1,500 pts were enrolled from 29 institutions. The multiplex gene testing was performed in 705/1,478 pts (48%), and OncomineDxTT was performed in 474/1,478 pts (32%). The implementation rate of biomarker testing was EGFR 84%, ALK 79%, ROS1 73%, BRAF 54%, MET 54%, and PD-L1 82%. The frequency of each driver mutation, EGFR, ALK, ROS1, BRAF, and MET were 25.6%, 3.9%, 2.3%, 1.7%, and 3.1%, respectively.

Conclusions

The implementation rate of multiplex gene testing was 48%. The positivity for each biomarker mutation was similar to that previously reported. We are currently collecting information on treatment and prognosis, and the rate of induction of systemic therapy and the proportion of patients receiving each targeted therapy drug based on each biomarker will be reported at this meeting. We hope that the results of this study would contribute to the establishment of a system where all patients with lung cancer can receive appropriate personalized medicine.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Non-profit Organization West Japan Oncology Group (WJOG).

Funding

Takeda Pharmaceutical Company Limited.

Disclosure

T. Matsubara: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co., Ltd. T. Sakamoto: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., Merck KGaA, Kyowa Kirin Co., Ltd., Novartis Pharma K.K., AstraZeneca K.K., MSD K.K., Illumina K.K., Takeda Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Pfizer Japan Inc., Hisamitsu Pharmaceutical Co., Inc., ONO Pharmaceutical Co., Ltd. T. Takahama: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca KK, Pfizer, Chugai, Roche Diagnostics, MSD; Financial Interests, Institutional, Principal Investigator: Takeda. S. Ikeda: Financial Interests, Institutional, Research Grant: AstraZeneca, Chugai; Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai, Ono, Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Taiho, Eli Lilly. M. mori: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Ono, Boehringer Ingelheim, Chugai, Kyowa-kirin, Nihon-kayaku, Shionogi, MSD, Eli Lilly, Novartis, Taiho, Otsuka, Pfizer, Takeda; Financial Interests, Personal, Research Grant: Daiichi-Sankyo; Financial Interests, Institutional, Research Grant: Chugai, Deltafly pharma, Ono, AstraZeneca. H. Kodama: Financial Interests, Personal, Speaker’s Bureau: Boehringer Ingelheim, Chugai. K. Maeno: Financial Interests, Personal and Institutional, Research Grant: Boehringer Ingelheim, Eli Lilly; Financial Interests, Personal, Invited Speaker: Ono, AstraZeneca, Chugai. S. Miura: Financial Interests, Personal, Speaker’s Bureau: Chugai, Taiho, Ono, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Boehringer-Ingelheim, Pfizer, Novartis, MSD, Kyowa Hakko Kirin, Daiichi Sankyo, Abbive, Nippon Kayaku, Amgen, Merck, Takeda Pharmaceutical. K. nishimura: Financial Interests, Personal and Institutional, Member of the Board of Directors, Stocks/Shares: Xcoo, Inc. M. Hiraoka: Non-Financial Interests, Institutional, Full or part-time Employment: Takeda Pharmaceutical Company Limited. H. Kenmotsu: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical Co, Ltd., Ono Pharmaceutical Co, Ltd., Boehringer Ingelheim, Eli Lilly K.K, Kyowa Hakko Kirin Co., Ltd., Bristol Myers Squibb, MSD, Novartis Pharma K.K., Daiichi-Sankyo Co., Ltd., AstraZeneca K.K., Pfizer, Taiho Pharma, Merk, Amgen inc., Bayer, Takeda Pharmaceutical Co., Ltd; Financial Interests, Institutional, Research Grant: AstraZeneca, Chugai Pharmaceutical Co, Ltd., Novartis Pharma K.K., Ono Pharmaceutical Co, Ltd., LOXO Oncology, Eli Lilly K.K; Non-Financial Interests, Personal, Principal Investigator: AstraZeneca K.K., Eli Lilly K.K, Boehringer Ingelheim, Takeda Pharmaceutical Co., Ltd. N. Yamamoto: Financial Interests, Personal, Invited Speaker: MSD K.K, AstraZeneca, Ono Pharmaceutical Co., Ltd., Thermo Fisher Scientific, Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Boehringer Ingelheim, Novartis, Pfizer Inc., Bristol Myers Squibb, NIPPON KAYAKU, GlaxoSmithKline K.K., Sanofi K.K., Hisamitsu Pharmaceutical Co., Inc., Merk biopharma; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Boehringer Ingelheim, Novartis, Bristol Myers Squibb, NIPPON KAYAKU, Life Technologies Japan Ltd., Amgen Inc., Guardant Health Japan, Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Research Grant: MSD K.K; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Pfizer Inc., Amgen Inc., Janssen Pharmaceutical K.K.; Financial Interests, Institutional, Funding: Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Toppan printing, Terumo. K. Nakagawa: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Amgen Inc., Nippon Kayaku Co., Ltd., AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., MSD K.K., Pfizer Japan Inc., Nippon Boehringer Ingelheim Co., Ltd., Taiho Pharmaceutical Co., Ltd., Bayer Yakuhin, Ltd., CMIC ShiftZero K.K., Life Technologies Japan Ltd., Neo Communication, Merck Biopharma Co., Ltd., Kyowa Kirin Co., Ltd., Takeda Pharmaceutical Co., Ltd., 3H Clinical Trial Inc., Care Net, Inc., Medical Review Co., Ltd., Medical Mobile Communications co., Ltd, YODOSHA CO., LTD., Nikkei Business Publications, Inc., Japan Clinical Research Operations, CMIC Co., Ltd., Novartis Pharma K.K., TAIYO Pharma Co., Ltd.; Financial Interests, Personal, Advisory Board: Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K.; Financial Interests, Institutional, Other, patents sales fee: Daiichi Sankyo Co., Ltd.; Financial Interests, Institutional, Research Grant: PAREXEL International Corp., PRA HEALTHSCIENCES, EPS Corporation., Kissei Pharmaceutical Co., Ltd., EPS International Co., Ltd,., Daiichi Sankyo Co., Ltd., Taiho Pharmaceutical Co., Ltd., MSD K.K., Ono Pharmaceutical Co., Ltd., PPD-SNBL K.K, SymBio Pharmaceuticals Limited., IQVIA Services JAPAN K.K., SYNEOS HEALTH CLINICAL K.K., Nippon Kayaku Co., Ltd., EP-CRSU Co., Ltd., Mebix, Inc., Bristol Myers Squibb K.K., Janssen Pharmaceutical K.K., Eisai Co., Ltd., AstraZeneca K.K., Mochida Pharmaceutical Co., Ltd., Covance Japan Inc., Japan Clinical Research Operations, Takeda Pharmaceutical Co., Ltd., GlaxoSmithKline K.K., Sanofi K.K., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Sysmex Corporation, Medical Reserch Support, Eli Lilly Japan K.K., Amgen Inc., Novartis Pharma K.K., Novartis Pharma K.K., SRL, Inc. All other authors have declared no conflicts of interest.