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Amivantamab plus Chemotherapy in NSCLC with EGFR Exon 20 Insertions.
Zhou, Caicun; Tang, Ke-Jing; Cho, Byoung Chul; Liu, Baogang; Paz-Ares, Luis; Cheng, Susanna; Kitazono, Satoru; Thiagarajan, Muthukkumaran; Goldman, Jonathan W; Sabari, Joshua K; Sanborn, Rachel E; Mansfield, Aaron S; Hung, Jen-Yu; Boyer, Michael; Popat, Sanjay; Mourão Dias, Josiane; Felip, Enriqueta; Majem, Margarita; Gumus, Mahmut; Kim, Sang-We; Ono, Akira; Xie, John; Bhattacharya, Archan; Agrawal, Trishala; Shreeve, S Martin; Knoblauch, Roland E; Park, Keunchil; Girard, Nicolas.
Affiliation
  • Zhou C; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Tang KJ; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Cho BC; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Liu B; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Paz-Ares L; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Cheng S; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Kitazono S; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Thiagarajan M; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Goldman JW; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Sabari JK; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Sanborn RE; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Mansfield AS; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Hung JY; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Boyer M; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Popat S; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Mourão Dias J; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Felip E; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Majem M; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Gumus M; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Kim SW; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Ono A; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Xie J; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Bhattacharya A; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Agrawal T; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Shreeve SM; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Knoblauch RE; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Park K; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
  • Girard N; From Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai (C.Z.), the Division of Pulmonary and Critical Care Medicine, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (K.-J.T.), and Harbin Medical University Cancer Hospital, Harbin (B.L.) - all in China; the Di
N Engl J Med ; 389(22): 2039-2051, 2023 Nov 30.
Article in En | MEDLINE | ID: mdl-37870976
ABSTRACT

BACKGROUND:

Amivantamab has been approved for the treatment of patients with advanced non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertions who have had disease progression during or after platinum-based chemotherapy. Phase 1 data showed the safety and antitumor activity of amivantamab plus carboplatin-pemetrexed (chemotherapy). Additional data on this combination therapy are needed.

METHODS:

In this phase 3, international, randomized trial, we assigned in a 11 ratio patients with advanced NSCLC with EGFR exon 20 insertions who had not received previous systemic therapy to receive intravenous amivantamab plus chemotherapy (amivantamab-chemotherapy) or chemotherapy alone. The primary outcome was progression-free survival according to blinded independent central review. Patients in the chemotherapy group who had disease progression were allowed to cross over to receive amivantamab monotherapy.

RESULTS:

A total of 308 patients underwent randomization (153 to receive amivantamab-chemotherapy and 155 to receive chemotherapy alone). Progression-free survival was significantly longer in the amivantamab-chemotherapy group than in the chemotherapy group (median, 11.4 months and 6.7 months, respectively; hazard ratio for disease progression or death, 0.40; 95% confidence interval [CI], 0.30 to 0.53; P<0.001). At 18 months, progression-free survival was reported in 31% of the patients in the amivantamab-chemotherapy group and in 3% in the chemotherapy group; a complete or partial response at data cutoff was reported in 73% and 47%, respectively (rate ratio, 1.50; 95% CI, 1.32 to 1.68; P<0.001). In the interim overall survival analysis (33% maturity), the hazard ratio for death for amivantamab-chemotherapy as compared with chemotherapy was 0.67 (95% CI, 0.42 to 1.09; P = 0.11). The predominant adverse events associated with amivantamab-chemotherapy were reversible hematologic and EGFR-related toxic effects; 7% of patients discontinued amivantamab owing to adverse reactions.

CONCLUSIONS:

The use of amivantamab-chemotherapy resulted in superior efficacy as compared with chemotherapy alone as first-line treatment of patients with advanced NSCLC with EGFR exon 20 insertions. (Funded by Janssen Research and Development; PAPILLON ClinicalTrials.gov number, NCT04538664.).
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Full text: 1 Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Carcinoma, Non-Small-Cell Lung / Antineoplastic Agents, Immunological / Lung Neoplasms Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Antineoplastic Combined Chemotherapy Protocols / Carcinoma, Non-Small-Cell Lung / Antineoplastic Agents, Immunological / Lung Neoplasms Limits: Humans Language: En Journal: N Engl J Med Year: 2023 Type: Article