NEJ026: Final overall survival analysis of bevacizumab plus erlotinib treatment for NSCLC patients harboring activating EGFR-mutations.

Authors

null

Makoto Maemondo

Iwate Medical University, Morioka, Japan

Makoto Maemondo , Tatsuro Fukuhara , Haruhiro Saito , Naoki Furuya , Kana Watanabe , Shunichi Sugawara , Shunichiro Iwasawa , Yoshio Tsunezuka , Ou Yamaguchi , Morihito Okada , Kouzou Yoshimori , Ichiro Nakachi , Akihiko Gemma , Koichi Azuma , Koichi Hagiwara , Toshihiro Nukiwa , Satoshi Morita , Kunihiko Kobayashi

Organizations

Iwate Medical University, Morioka, Japan, Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan, Department of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan, St. Marianna University School of Medicine, Kawasaki, Japan, Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan, Department of Medical Oncology, Chiba University, Chiba, Japan, Ishikawa Prefectural Central Hospital, Kanazawa, Japan, Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Japan, Hiroshima University Hospital, Department of Surgical Oncology, Hiroshima, Japan, Clinical Cancer Center, Fukujuji Hospital, JATA, Tokyo, Japan, Pulmonary Division, Internal Medicine, Saiseikai Utsunomiya Hospital, Utsunomiya, Japan, Department of Pulmonary Medicine and Oncology, Nippon Medical School, Tokyo, Japan, Division of Respirology, Neurology, and Rheumatology, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan, Division of Pulmonary Medicine, Department of Internal Medicine, Jichi Medical University, Shimotsuke, Japan, Department of Respiratory Medicine, Tohoku University, Sendai, Japan, Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan

Research Funding

Pharmaceutical/Biotech Company
Chugai Pharmaceutical

Background: In NEJ026, a phase III trial comparing bevacizumab plus erlotinib (BE) to erlotinib monotherapy (E) for EGFR-mutated non-small-cell lung cancer (NSCLC), we demonstrated the progression-free survival (PFS) of BE was significantly superior to E (Saito et al. Lancet Oncol. 2019 May;20(5):625-635.). However overall survival analysis were immature at the cutoff date. Methods: Chemotherapy-naïve pts with advanced non-squamous NSCLC harboring EGFR-mutation were randomly assigned to receive either combination with erlotinib (150 mg daily) plus bevacizumab (15 mg/kg iv q3w) or erlotinib (150 mg daily). The primary endpoint was PFS. Secondary endpoints were OS, RR, safety, and QoL. Results: The 226 pts were assigned to BE (n=112) and E (n=114). For the follow-up OS analysis, the data cut-off date was 30 November 2019. Median follow up time was 39.2 months. Median OS was 50.7 months (95% CI, 37.3 months to not reached) with BE and 46.2 months (95% CI, 38.2 months to not reached) with E (hazard ratio, 1.00; 95% CI, 0.68 to 1.48). Twenty-nine patients (25.9%) in BE and twenty-six patients (23.2%) in E were treated by osimertinib as second line treatment. The median survival time between enrollment and progressive disease of second-line treatment (median PFS2) was 28.6 months (95% CI, 22.1 months to 35.9) with BE and 24.3 months (95% CI, 20.4 months to 29.1 months) with E (hazard ratio, 0.80; 95% CI, 0.59 to 1.10). In both arms, the median OS of patients with osimertinib second-line treatment were longer than other second-line chemotherapy groups [50.7 months (95% CI, 38.0 months to 50.7 months) vs 40.1 months (95% CI, 29.5 months to not reached), (hazard ratio, 0.645; 95% CI, 0.40 to 1.03), respectively. Conclusion: The additional effect of bevacizumab on erlotinib monotherapy for NSCLC with EGFR mutations gradually decreased in the order of PFS2 and survival, with no significant differences. Clinical trial information: UMIN000017069.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Oral Abstract Session

Session Title

Lung Cancer—Non-Small Cell Metastatic

Track

Lung Cancer

Sub Track

Metastatic Non–Small Cell Lung Cancer

Clinical Trial Registration Number

UMIN000017069

Citation

J Clin Oncol 38: 2020 (suppl; abstr 9506)

DOI

10.1200/JCO.2020.38.15_suppl.9506

Abstract #

9506

Abstract Disclosures

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