A Phase 2 Study of Atezolizumab for Pretreated NSCLC With Idiopathic Interstitial Pneumonitis

doi:10.1016/j.jtho.2020.08.018

Journal of Thoracic Oncology

Volume 15, Issue 12, December 2020, Pages 1935-1942

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Abstract

Introduction

Interstitial pneumonia (IP) is one of the most common and poor prognostic comorbidities in patients with NSCLC and a known risk factor for pneumonitis. Atezolizumab monotherapy is an established treatment for recurrent NSCLC and reported to have a lower risk of pneumonitis than programmed cell death protein 1 inhibitors. This study aimed to assess the safety and efficacy of atezolizumab monotherapy in patients with pretreated advanced or recurrent NSCLC with idiopathic IP.

Methods

Patients with advanced or recurrent NSCLC with comorbid idiopathic, chronic fibrotic IP with % forced vital capacity of greater than 70% and no history of immune checkpoint inhibitors were enrolled. The patients received atezolizumab (1200 mg) every 3 weeks until the discontinuation criteria were met. The primary end point of this study was the 1-year survival rate. A sample size of 38 patients was set.

Results

This study was terminated early owing to high incidence of pneumonitis. A total of 17 patients were enrolled, with a median age of 70 years. The median % forced vital capacity and % diffusing capacity for carbon monoxide at baseline were 85.4% and 54.4%, respectively. The incidence of pneumonitis was 29.4% (5 of 17) for all grades, 23.5% (4 of 17) for grade greater than or equal to 3, and 5.9% (1 of 17) for grade 5. A total of 57.1% patients (4 of 7) with honeycomb lung developed pneumonitis with a grade greater than or equal to 3, whereas only one patient (10%) without honeycomb lung (n = 10) with grade 1 pneumonitis was found.

Conclusions

Patients with NSCLC with comorbid IP as defined by the selection criteria for this study might have an increased risk of immune checkpoint inhibitor–induced pneumonitis.

Keywords

Atezolizumab

Non–small cell lung cancer

Interstitial pneumonia

Pneumonitis

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: Disclosure: Dr. Ikeda reports receiving grants and personal fees from Chugai Pharmaceuticals, during the conduct of the study; grants and personal fees from AstraZeneca; and personal fees from Boehringer Ingelheim, Ono Pharmaceuticals, Taiho Pharmaceuticals, Bristol-Myers Squibb, and Eli Lilly, outside of the submitted work. Dr. Kato reports receiving grants and personal fees from Chugai Pharmaceuticals, during the conduct of the study; grants and personal fees from AbbVie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Merck Biopharma, Merck Sharp & Dohme, Novartis, Ono Pharmaceuticals, Pfizer, and Taiho Pharmaceuticals; personal fees from Daiichi Sankyo, F. Hoffmann-La Roche, Nippon Kayaku, Nitto Denko, Shionogi, Sumitomo Dainippon, and Takeda Pharmaceuticals; and grants from Astellas, Kyorin, Kyowa Kirin, and Regeneron, outside of the submitted work. Dr. Kenmotsu reports receiving grants and personal fees from Chugai Pharmaceuticals, during the conduct of the study; grants and personal fees from AstraZeneca and Novartis; and personal fees from Ono Pharmaceuticals, Boehringer Ingelheim, Eli Lilly, Kyowa Hakko Kirin, Bristol-Myers Squibb, Merck Sharp & Dohme, Daiichi Sankyo, and Pfizer, outside of the submitted work. Dr. Ogura reports receiving personal fees from Shionogi, Nippon Boehringer Ingelheim, and Eisai, outside of the submitted work. Dr. S. Iwasawa reports receiving personal fees from AstraZeneca, Daiichi Sankyo, Merck Sharp & Dohme, and Chugai Pharmaceuticals; and grants and personal fees from Ono Pharmaceuticals, outside of the submitted work. Dr. Sato reports receiving personal fees from Ono Pharmaceuticals, Novartis, Taiho Pharmaceuticals, and Chugai Pharmaceuticals, outside of the submitted work. Harada reports receiving personal fees from Chugai Pharmaceuticals, outside of the submitted work. Dr. Kubota reports receiving grants and personal fees from Taiho Pharmaceuticals; grants from Boehringer Ingelheim and Ono Pharmaceuticals; and personal fees from Merck Sharp & Dohme and Chugai Pharmaceuticals, outside of the submitted work. Dr. Tokito reports receiving personal fees from AstraZeneca, Merck Sharp & Dohme, Boehringer Ingelheim, and Chugai Pharmaceuticals, outside of the submitted work. Dr. I. Okamoto reports receiving grants and personal fees from AstraZeneca, Taiho Pharmaceuticals, Boehringer Ingelheim, Ono Pharmaceuticals, Merck Sharp & Dohme, Eli Lilly, Bristol-Myers Squibb, and Chugai Pharmaceuticals; grants from Astellas, Novartis, and AbbVie; and personal fees from Pfizer, outside of the submitted work. Dr. Furuya reports receiving personal fees from Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim Japan, Taiho Pharmaceuticals, Ono Pharmaceuticals, Pfizer Japan, and Chugai Pharmaceuticals, outside of the submitted work. Dr. Yokoyama reports receiving personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Ono Pharmaceuticals, Taiho Pharmaceuticals, Merck Sharp & Dohme, Pfizer, Novartis, and Chugai Pharmaceuticals, outside of the submitted work. Dr. T. Iwasawa reports receiving personal fees from Ono Pharmaceuticals and Boehringer Ingelheim and grants from Canon Medical Systems, outside of the submitted work. Dr. Yamanaka reports receiving grants and personal fees from Takeda Pharmaceuticals, Chugai Pharmaceuticals, Boehringer Ingelheim, Taiho Pharmaceuticals, Daiichi Sankyo, and Bayer; grants from Ono Pharmaceuticals, Merck, Astellas, and Eli Lilly; and personal fees from Pfizer, Sysmex, Huya Biosciences, and Gilead Sciences, outside of the submitted work. Dr. H. Okamoto reports receiving grants from AMED, Takeda Pharmaceuticals, Merck, and Daiich Sankyo; grants and personal fees from Merck Sharp & Dohme, Ono Pharmaceuticals, AstraZeneca, Chugai Pharmaceuticals, Taiho Pharmaceuticals, Bristol-Myers Squibb, and Eli Lilly; and personal fees from Kyorin, Boehringer Ingelheim, and Novartis, outside of the submitted work. Dr. Hosokawa declares no conflict of interest.