NEJ043: A phase 2 study of atezolizumab (atezo) plus bevacizumab (bev) plus carboplatin (carbo) plus paclitaxel (pac; ABCP) for previously treated patients with NSCLC harboring EGFR mutations (EGFRm).

Authors

Naoki Furuya

Naoki Furuya

Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, OH, Japan

Naoki Furuya , Satoshi Watanabe , Atsushi Nakamura , Jun Shiihara , Ichiro Nakachi , Hisashi Tanaka , Mika Nakao , Koichi Minato , Masahiro Seike , Shinichi Sasaki , Akira Kisohara , Susumu Takeuchi , Ryoichi Honda , Kei Takamura , Hiroshi Kagamu , Kenichi Yoshimura , Toshiaki Kikuchi , Kunihiko Kobayashi

Organizations

Division of Respiratory Medicine, Department of Internal Medicine, St. Marianna University School of Medicine, Kawasaki, OH, Japan, Department of Respiratory Medicine and Infectious Diseases, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan, Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan, Jichi Medical University Saitama Medical Center, Saitama, Japan, Pulmonary Division, Internal Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan, Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Japan, Shimane University Faculty of Medicine, Izumo, Japan, Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan, Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan, Juntendo University Urayasu Hospital, Chiba, Japan, Kasukabe Medical center, Kasukabe, Japan, Division of General Thoracic & Thyroid Surgery, Tokyo Medical University, Tokyo, Japan, Department of Respiratory Medicine, Asahi General Hospital, Asahi, Japan, Obihiro Kosei General Hospital, Obihiro, Japan, Niigata University, Niigata, Japan, Kyoto University Hospital, Kyoto, Japan, Department of Respiratory Medicine and Infectious Diseases, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan, Department of Pulmonary Medicine, Saitama Medical University International Medical Center, Hidaka, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: Previous studies have demonstrated poor clinical outcomes of patients (pts) with EGFRm NSCLC treated with PD-1/PD-L1 inhibitors. However, a recent subgroup analysis of the IMpower150 trial suggested the effectiveness of ABCP in NSCLC with EGFRm. The aim of this study is to further evaluate efficacy and safety of ABCP in patients with EGFRm NSCLC. Methods: This single-arm multicenter phase 2 study included pts with nonsquamous NSCLC harboring sensitizing EGFRm with prior EGFR-TKI therapy. Pts received the combination dose of atezo 1200 mg, bev 15 mg/kg, carbo AUC 6 mg/mL/min and pac 175 mg/m2 every 3 weeks up to 4 cycles followed by atezo plus bev until loss of clinical benefit. The primary endpoint was PFS by extramural review (ER). The key secondary endpoints included OS, ORR, DoR, relative dose intensity of pac, and safety. Results: 60 pts were enrolled (median age 68 y [40–74 y], 67% were female, 55% were Ex19del and 40% were L858R). At data cutoff (November 30, 2021), median follow-up was 12.8 months in the ITT population. Median cycles of induction and maintenance therapy were 4 and 9, respectively. Median PFS was 7.4 month (95% CI, 5.7-8.2) and median OS was 18.9 month (95% CI, 13-not reached). Confirmed ORR by ER was 56% (95% CI, 43-69) and median DoR was 7.1 months (95% CI, 4.9-9.8). T790M was associated with a favorable PFS and response to the combination therapy (PFS 8.1 vs 6.8, ORR 71% vs 50%). Relative dose intensity of pac was 84%. Grade ≥3 adverse events (AEs) were reported in 92% of pts and the most common grade ≥3 AE was neutropenia (63%). Interstitial lung disease occurred in one patient (2%). AEs leading to treatment discontinuation occurred in 12% of pts. Conclusions: NEJ043 study showed that the median PFS of ABCP was 7.4 months with good tolerability. We will continue to investigate the tail plateau phenomenon of PFS and OS to conclude the clinical efficacy. Clinical trial information: 031190066.

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Abstract Details

Meeting

2022 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

031190066

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr 9110)

DOI

10.1200/JCO.2022.40.16_suppl.9110

Abstract #

9110

Poster Bd #

96

Abstract Disclosures