J-TAIL-2: A prospective observational study of atezolizumab (atezo) combination therapy in patients (pts) with non-small cell lung cancer (NSCLC) in Japan.

Authors

null

Yasutaka Watanabe

Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan

Yasutaka Watanabe , Makoto Nishio , Kadoaki Ohashi , Atsushi Osoegawa , Eiki Kikuchi , Hideharu Kimura , Yasushi Goto , Junichi Shimizu , Eisaku Miyauchi , Hiroshige Yoshioka , Ichiro Yoshino , Toshihiro Misumi , Masafumi Yamaguchi , Kouzou Yoshimori , Masahiro Seike , Hironori Yoshida , Kazumi Nishino , Asako Miwa , Misa Tanaka , Akihiko Gemma

Organizations

Department of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan, Department of Thoracic Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan, Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan, Department of Pulmonary and Breast Surgery, Oita University School of Medicine, Oita, Japan, Department of Respiratory Medicine, Faculty of Medicine, Hokkaido University, Sapporo, Japan, Department of Respiratory Medicine, Kanazawa University, Kanazawa, Japan, Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan, Department of Thoracic Oncology, Aichi Cancer Center Hospital, Nagoya, Japan, Department of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan, Department of Thoracic Oncology, Kansai Medical University, Osaka, Japan, International University of Health and Welfare, Narita Hospital, Narita, Japan and General Thoracic Surgery, Chiba University Hospital, Chiba, Japan, Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan, Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan, Fukujuji Hospital, Tokyo, Japan, Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan, Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan, Chugai Pharmaceutical Co, Ltd, Tokyo, Japan, Nippon Medical School, Tokyo, Japan

Research Funding

Chugai Pharmaceutical Co, Ltd

Background: The IMpower130 (West et al. Lancet Oncol 2018), IMpower132 (Nishio et al. JTO 2021) and IMpower150 (1) trials led to the approval of first-line atezo combination therapies for NSCLC. As data remain limited in Japanese pts, J-TAIL-2 (NCT04501497) is evaluating the efficacy and safety of 3 atezo combination therapies for NSCLC in the clinical setting in Japan. Methods: Japanese pts had unresectable advanced or recurrent NSCLC, were ≥20 y old, and were scheduled to start atezo combination therapy in clinical practice. Pts received atezo + carboplatin and nab-paclitaxel (atezo + CnP), atezo + carboplatin or cisplatin + pemetrexed (atezo + PP) or atezo + bevacizumab + carboplatin + paclitaxel (atezo + bev + CP). The primary endpoint was 12-mo OS rate. Secondary endpoints included OS and safety. Efficacy and safety were analyzed in the IMpower-unlike (did not meet the main eligibility criteria of each IMpower study) and IMpower-like subgroups. Geriatric assessment (G8) was done in pts ≥70 y old at baseline; a score < median vs ≥ median indicated poorer health status. Results: From Aug 21, 2020, to data cut off (Feb 3, 2023), 814 pts were enrolled at 150 sites (atezo + CnP, n=217; atezo + PP, n=211; atezo + bev + CP, n=386). Baseline characteristics in the efficacy analysis population (n=791) are shown (Table). The IMpower-unlike group included pts with ECOG PS ≥2, brain metastases or interstitial lung disease. Twelve-mo OS rates (95% CI) were 62.9% (55.8, 69.2), 72.1% (65.2, 77.9) and 68.3% (63.2, 72.9), and median OS was 19.7, 23.5 and 17.3 mo with atezo + CnP, atezo + PP and atezo + bev + CP, respectively. OS HRs (95% CI) in the IMpower-unlike vs -like subgroups were 1.36 (0.91, 2.05), 1.08 (0.70, 1.68) and 1.49 (1.09, 2.06), respectively. The median G8 score for all evaluable pts was 13; in pts with a G8 score < median vs ≥ median, OS HRs (95% CI) were 2.10 (1.22, 3.61), 3.53 (1.95, 6.37) and 2.04 (1.22, 3.40) with atezo + CnP, atezo + PP and atezo + bev + CP, respectively. In the safety analysis population (n=800), Grade ≥3 AEs occurred in 60.4% of pts and Grade 5 AEs in 1.3%. Conclusions: In Japanese pts, the efficacy and safety of each atezo combination therapy were comparable to those seen in the relevant IMpower studies and largely consistent in pts who would have been ineligible for the trials. Pts aged ≥70 y with a G8 score < median vs ≥ median had poorer efficacy and safety outcomes. 1. Socinski et al. NEJM 2018. Clinical trial information: NCT04501497.

n (%)Atezo + CnP
n=208
Atezo + PP
n=204
Atezo + Bev + CP
n=379
Age ≥75 y53 (25.4)75 (36.8)41 (10.8)
ECOG PS ≥227 (13.0)18 (8.8)27 (7.1)
Brain metastases45 (21.6)42 (20.6)131 (34.6)
Interstitial lung disease20 (9.6)5 (2.5)9 (2.4)
PD-L1 expression on ≥50% of tumor cells (22C3)64 (35.8)42 (24.0)75 (25.0)
EGFR+16 (8.2)26 (13.7)194 (52.9)
Creatinine clearance <45 mL/min26 (12.5)15 (7.4)38 (10.1)
IMpower-unlike133 (63.9)137 (67.2)258 (68.1)
G8 score < median 1360 (28.8)49 (24.0)61 (16.1)

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT04501497

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr 8573)

DOI

10.1200/JCO.2024.42.16_suppl.8573

Abstract #

8573

Poster Bd #

437

Abstract Disclosures