Updated Analysis of NEJ009: Gefitinib-Alone Versus Gefitinib Plus Chemotherapy for Non-Small-Cell Lung Cancer With Mutated EGFR .

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. In a randomized, open-label, phase III NEJ009 study, gefitinib plus chemotherapy significantly improved progression-free survival (PFS) and overall survival (OS) compared with gefitinib-alone in patients with untreated non-small-cell lung cancer harboring mutations in epidermal growth factor receptor. Herein, we report the updated survival outcome and long-term tolerability. Patients were randomly assigned to gefitinib (gefitinib 250 mg orally, once daily) and gefitinib combined with carboplatin plus pemetrexed (GCP in a 3-week cycle for six cycles followed by concurrent gefitinib and pemetrexed maintenance) groups. At the data cutoff (May 22, 2020), GCP demonstrated significantly better PFS2 (hazard ratio, 0.77; 95% CI, 0.62 to 0.97; P = .027) than gefitinib. However, the updated median OS was 38.5 months (95% CI, 31.1 to 47.1) and 49.0 months (95% CI, 41.8 to 56.7) in the gefitinib and GCP groups, respectively (hazard ratio, 0.82; 95% CI, 0.64 to 1.06; P = .127). The OS in both groups was similar for the overall patient population. No severe adverse events occurred since the first report. This updated analysis revealed that the GCP regimen improved PFS and PFS2 with an acceptable safety profile compared with gefitinib-alone. GCP is more efficient than gefitinib monotherapy as a first-line treatment for non-small-cell lung cancer with epidermal growth factor receptor mutations.
Competing Interests: Eisaku MiyauchiHonoraria: AstraZeneca, Chugai Pharma, Boehringer Ingelheim, Ono Pharmaceutical, Lilly, Taiho Pharmaceutical, Kyowa Kirin, Novartis, Daiichi Sankyo, Bristol Myers Squibb, MerckConsulting or Advisory Role: Chugai Pharma, Boehringer Ingelheim, Lilly, Kyowa KirinResearch Funding: Boehringer Ingelheim, Lilly (Inst), Chugai Pharma (Inst) Satoshi MoritaHonoraria: AstraZeneca Japan, Bristol Myers Squibb Company, Chugai Pharma, Taiho Pharmaceutical, Lilly Japan, MSD K.K, Nippon Boehringer Ingelheim, Ono Pharmaceutical, Pfizer Japan Inc, Eisai, Novartis, Kyowa Kirin Co LtdResearch Funding: Eisai (Inst) Atsushi NakamuraHonoraria: AstraZeneca, Chugai Pharma, Lilly Japan, Kyowa Kirin, Taiho Pharmaceutical, Novartis, Thermo Fisher Scientific Yukio HosomiSpeakers' Bureau: AstraZeneca, Taiho Pharmaceutical, Lilly Japan, Chugai Pharma, Ono Pharmaceutical, Bristol Myers Squibb Japan, MSD, Kyowa Kirin International Satoshi IkedaHonoraria: Chugai Pharma, Boehringer Ingelheim, Taiho Pharmaceutical, Ono Pharmaceutical, AstraZeneca, Bristol Myers Squibb, Lilly, Pfizer, TakedaResearch Funding: Chugai Pharma, AstraZeneca Masahiro SeikeHonoraria: AstraZeneca, MSD K.K, Chugai Pharma, Taiho Pharmaceutical, Lilly, Ono Pharmaceutical, Bristol Myers Squibb, Nippon Boehringer Ingelheim, Novartis, Kyowa Hakko Kirin, Nippon Kayaku, Daiichi-Sankyo CompanyResearch Funding: Taiho Pharmaceutical, Chugai Pharma, Lilly, MSD K.K, Nippon Boehringer Ingelheim, Nippon Kayaku Yuka FujitaResearch Funding: Novartis (Inst), Asahi Kasei (Inst), Ono Pharmaceutical (Inst), Otsuka (Inst), Lilly Japan (Inst) Koichi MinatoHonoraria: Bristol Myers Squibb Japan, Chugai PharmaResearch Funding: Ono Pharmaceutical (Inst), Taiho Pharmaceutical (Inst) Ryo KoHonoraria: Taiho Pharmaceutical, Chugai Pharma, Lilly Japan, Boehringer Ingelheim, Pfizer, AstraZeneca, Ono Pharmaceutical, Daiichi Sankyo/UCB Japan, TakedaResearch Funding: MSD Koichi HagiwaraHonoraria: AstraZeneca, Chugai Pharma, Taiho Pharmaceutical, Boehringer Ingelheim, Ono Pharmaceutical, Novartis, Kyorin, Takeda, Lilly, Nippon Shinyaku, Kyowa Kirin, Nippon Kayaku, Bayer YakuhinResearch Funding: Ono Pharmaceutical, Taiho Pharmaceutical, Boehringer Ingelheim (Inst), Eiken ChemicalPatents, Royalties, Other Intellectual Property: LSI Medience Kunihiko KobayashiSpeakers' Bureau: AstraZeneca, Takeda Toshihiro NukiwaConsulting or Advisory Role: Nippon Boehringer Ingelheim, Grifols Akira InoueHonoraria: AstraZeneca, Boehringer Ingelheim, Lilly Japan, Chugai Pharma, Ono Pharmaceutical, Bristol Myers Squibb Japan, Shionogi, Daiichi Sankyo, Kyowa Hakko Kirin, Nippon Kayaku, Mundipharma, Novartis, PfizerConsulting or Advisory Role: AstraZeneca, Lilly Japan, MSDResearch Funding: Boehringer Ingelheim (Inst), Lilly Japan (Inst), Kyowa Hakko Kirin (Inst), Chugai Pharma (Inst), Shionogi (Inst)No other potential conflicts of interest were reported.