Abstract 38P
Background
First-line therapy with PD-1 or PD-L1 antibody, is standard of care for patients with PD-L1 high expression non-small cell lung cancer (NSCLC). And it is known that bevacizumab has immunomodulatory effect and various immune responses are induced by adding bevacizumab to immune checkpoint inhibitors. A phase II study of atezolizumab with bevacizumab for patients with PD-L1 high expression non-squamous NSCLC (WJOG10718L/@ Be Study) showed an overall response rate (ORR) of 64.1% (90% CI: 49.69–76.83%). We report the 2-year follow-up data here.
Methods
Patients with PD-L1 expression on at least 50%were assessed by PD-L1 IHC 22C3 pharmDx assay, and no driver oncogene alterations such as EGFR, ALK, or ROS1 untreated non-squamous NSCLC were enrolled. Atezolizumab (1,200 mg) and bevacizumab (15 mg/kg) were given intravenously every 3 weeks. Primary endpoint was ORR for patients who had evaluable lesions of tumor changes evaluated by central review based on RECIST 1.1. Secondary endpoints were progression-free survival (PFS), duration of response (DOR) by independent radiographic committee, overall survival (OS), and safety.
Results
From Aug 2018 to Jan 2020, 40 pts were enrolled and treated with study therapy. The data cut off was 2 years after the last patient was enrolled. The median follow-up period was 29.3 months. The median PFS and DOR were 15.74 months (95% CI: 5.65–23.98 months) and 15.87 (95% CI: 4.17–33.28 months), respectively. The median OS was 36.07 (95% CI: 18.37- months). New additional un-known toxicity was not reported in these 2 years.
Conclusions
The data of 2-year follow-up supported the favorable PFS, DOR and OS of this combination regimen for patients with PD-L1 high expression non-squamous NSCLC.
Clinical trial identification
JapicCTI-184038.
Legal entity responsible for the study
West Japan Oncology Group.
Funding
Chugai Pharmaceutical.
Disclosure
T. Seto: Financial Interests, Personal, Invited Speaker: Eli Lilly Japan, Takeda Pharmaceutical, Chugai Pharmaceutical, MSD, Novartis Pharma, Ono Pharmaceutical, Pfizer Japan, Eli Lilly Japan, AstraZeneca, Amgen, Bristol Myers Squibb, AnHeart Therapeutics, Novartis Pharma; Financial Interests, Personal, Full or part-time Employment: Precision Medicine Asia; Non-Financial Interests, Personal, Member of Board of Directors: West Japan Oncology Group. R. Toyozawa: Financial Interests, Personal, Invited Speaker: AstraZeneca, Chugai Pharmaceutical, Eli Lilly Japan, MSD, Ono Pharmaceutical, Pfizer Japan, Taiho Pharmaceutical, Takeda Pharmaceutical, Bristol Myers Squibb Japan, Nippon Kayaku, Thermo Fisher Scientific; Financial Interests, Institutional, Principal Investigator: AbbVie, Amgen, AnHeart Therapeutics, Daiichi Sankyo, Eli Lilly Japan, Novartis Pharma, Pfizer Japan, Takeda Pharmaceutical. S. Sugawara: Financial Interests, Personal, Other, Lecture fee: AstraZeneca, Chugai Pharma, Nippon Boehringer Ingelheim, Taiho Pharmaceutical, Pfizer, Lilly, Novartis, Bristol Myers Squibb, Ono Pharmaceutical, MSD K.K, Kyowa Kirin, Takeda, Nippon Kayaku, Merck, Amgen, Thermo Fisher Scientific; Financial Interests, Personal, Other, Lecture Fee: Eisai, Sysmex; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Chugai Pharma, MSD K.K, Daiichi Sankyo, Bristol Myers Squibb, AnHeart, Ono Pharmaceutical, Nippon Boehringer Ingelheim, AbbVie, Parexel International, Amgen, Taiho Pharmaceutical, Accerise, A2 Healthcare, EPS Corporation, Syneos Health, PPD-SNBL. H. Hayashi: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical Co. Ltd., Bristol Myers Squibb Co. Ltd, AstraZeneca K.K, Boehringer Ingelheim Japan Inc., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo K.K, Eli Lilly Japan K.K, Merck Biopharma Co. Ltd, MSD K.K., Novartis Pharmaceuticals K.K, Pfizer, Takeda Pharmaceutical Co. Ltd, Janssen Pharmaceutical K.K., GSK plc., Daiichi Sankyo, Inc.; Financial Interests, Personal, Advisory Board: Bristol Myers Squibb Co. Ltd, Eli Lilly Japan K.K, Pfizer, AstraZeneca K.K, Daiichi Sankyo Co. Ltd; Financial Interests, Personal, Royalties, Currently no provided: Sysmex; Financial Interests, Institutional, Invited Speaker: IQVIA Services Japan K.K, Syneos Health Clinical K.K., EPS Corporation., Nippon Kayaku Co., Ltd., Takeda Pharmaceutical Co., Ltd., MSD K.K., Amgen Inc., Taiho Pharmaceutical Co., Ltd., Bristol Myers Squibb Company, Janssen Pharmaceutical K. K., CMIC CO., Ltd., Pfizer R&D Japan G.K., Labcorp Development Japan K.K., Kobayashi Pharmaceutical Co., Ltd., Pfizer Japan Inc., AbbVie Inc., A2 Healthcare Corp., Eli Lilly Japan K.K., Medpace Japan KK, EPS International Co., Ltd,., Covance Japan Inc., EP-CRSU CO., LTD., GSK K.K., Sanofi K.K., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., PRA Health Sciences Inc., Astellas Pharma Inc., Ascent Development Services, AstraZeneca K.K., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Merck Biopharma Co., Ltd, Mochida Pharmaceutical Co., Ltd., Japan Clinical Research Operations; Financial Interests, Institutional, Research Grant: Japanese Gastric Cancer Association, Clinical Research Support Center Kyushu, Japan Clinical Caner Research Organization, Ono Pharmaceutical Co., Ltd., Medical Research Support, Eisai Co., Ltd, Shionogi & Co., Ltd., Otsuka Pharmaceutical Co., Ltd., Chugai Pharmaceutical Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Bayer Yakuhin, Ltd, Kyowa Kirin Co., Ltd.; Financial Interests, Institutional, Funding: SRL Medisearch Inc., Eisai Inc., Thoracic Oncology Research Group(TORG), West Japan Oncology Group (WJOG), Comprehensive Support Project for Oncological Research of Breast Cancer (CSPOR-BC), Mebix, Inc.; Non-Financial Interests, Personal, Member: West Japan Oncology Group, Japanese Society of Medical Oncology. T. Kato: Financial Interests, Personal, Advisory Board, speaker: Pfizer; Financial Interests, Personal, Advisory Board, speaker, consultancy: Merck Biopharma, MSD, AstraZeneca; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Invited Speaker: Ono, Novartis, Eli Lilly, Bristol-Meyers Squibb, Boehringer Ingelheim, Amgen, Roche; Financial Interests, Personal, Other, consultancy: Takeda, Daiichi Sankyo; Financial Interests, Personal, Other, consultancy, speaker: Chugai; Financial Interests, Personal, Full or part-time Employment, Family member: Eli Lilly; Financial Interests, Institutional, Invited Speaker: AbbVie, Amgen, Bayer, BeiGene, Blueprint Medicines, Chugai, Daiichi Sankyo, Eli Lilly, Gilead, GSK, Haihe Biopharma, Janssen, MSD, Merck Biophama, Novartis, Pfizer, Regeneron, Takeda, BMS, Arrivent; Financial Interests, Personal and Institutional, Invited Speaker, Local PI: AstraZeneca. H. Yoshioka: Financial Interests, Personal, Invited Speaker, Lecture fee: Eli Lilly Japan K.K., Takeda Pharmaceutical, Nippon Boehringer Ingelheim, Nippon Kayaku, Chugai Pharmaceutical, Taiho Pharmaceutical, Bristol Myers Squibb, MSD, AstraZeneca, Ono Pharmaceutical, Novartis Pharma, Kyowa Kirin, Otsuka Pharmaceutical, Amgen, Pfizer, Daiichi Sankyo, Nipro Pharma, Merck Biopharma; Financial Interests, Personal, Other, Consulting fee: Delta-Fly Pharma, Inc.; Financial Interests, Institutional, Invited Speaker: Daiichi Sankyo, AstraZeneca, Janssen Pharmaceutical, MSD, Novartis Pharma, Delta-Fly Pharma, Boehringer Ingelheim. H. Daga: Financial Interests, Personal, Invited Speaker: Chugai pharmaceutical, AstraZeneca. K. Azuma: Financial Interests, Personal, Invited Speaker, Lecture fee: AstraZeneca, MSD, Chugai Pharmaceutical, Ono Pharmaceutical, Bristol Myers Squibb, Takeda Pharmaceutical. K. Nishino: Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical CO., LTD., MSD, Amgen, Janssen Pharmaceutical K.K., Novartis Pharmaceuticals, Pfizer, Eli Lilly Japan, Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai pharmaceutical, AstraZeneca, Nippon Boehringer Ingelheim, Daiichi Sankyo Company Limited, Nippon Kayaku Co., Ltd., Daiichi Sankyo Co., Ltd., Mochida Pharmaceutical Co., Ltd., Yuyu Teijin Medicare Inc., Varian Medical Systems, Inc.; Financial Interests, Personal, Advisory Board: Pfizer, Janssen Pharmaceutical K.K., AstraZeneca; Financial Interests, Institutional, Invited Speaker: ONO Pharmaceutical CO., LTD., Taiho Pharmaceutical CO., LTD., MSD, AbbVie, Daiichi Sankyo Company, Limited, Amgen, Eli Lilly, Eisai Co., Ltd., Sanofi K.K., Janssen Pharmaceutical K.K., Novartis Pharmaceuticals, Pfizer, Merck Biopharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Chugai pharmaceutical, Merus, AstraZeneca. I. Okamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Takeda Pharmaceutical, Daiichi Sankyo, MSD, Pfizer, Taiho Pharmaceutical, Novartis; Financial Interests, Institutional, Invited Speaker: Chugai Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, GSK, MSD, Taiho Pharmaceutical, Novartis. N. Yamamoto: Financial Interests, Personal, Invited Speaker: MSD K.K, AstraZeneca, Ono Pharmaceutical CO., LTD., Daiichi Sankyo CO., LTD., Taiho Pharmaceutical CO., LTD., Takeda Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Novartis, Pfizer Inc., Amgen Inc., Merck Biopharma; Financial Interests, Personal, Advisory Board: AstraZeneca, Daiichi Sankyo CO., LTD., Takeda Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Eli Lilly Japan K.K., Novartis; Financial Interests, Institutional, Research Grant: MSD K.K; Financial Interests, Institutional, Invited Speaker: AstraZeneca, Taiho Pharmaceutical CO., LTD., Takeda Pharmaceutical CO., LTD., Amgen Inc., Janssen Pharmaceutical K.K., Novartis, Eisai, Eli Lilly Japan; Financial Interests, Institutional, Funding: Daiichi Sankyo CO., LTD., Taiho Pharmaceutical CO., LTD., Chugai Pharmaceutical CO., LTD., Sanofi. All other authors have declared no conflicts of interest.