Lung cancer (Amsterdam, Netherlands) · 2025
Patient-reported outcomes and time to symptomatic progression from PAPILLON: amivantamab plus chemotherapy vs chemotherapy as first-line treatment of EGFR exon 20 insertion-mutated advanced NSCLC.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Paz-Ares Luis, Veillon Remi, Majem Margarita, Zhou Caicun, Tang Ke-Jing, Kim Sang-We, Richardson Gary, Girard Nicolas, Sanborn Rachel E, Mansfield Aaron S, Park Keunchil, Schuchard Julia, Diels Joris, Sermon Jan, Bhattacharya Archan, Lorenzini Patricia, Wortman-Vayn Honeylet, Knoblauch Roland E, Agrawal Trishala, Baig Mahadi, Ono Akira, Sabari Joshua K
Аннотация
BACKGROUND: Epidermal growth factor receptor (EGFR) exon 20 insertions (Ex20ins) are the third most common type of EGFR mutation, occurring in up to 12% of EGFR-mutated non-small cell lung cancers (NSCLC). Ex20ins-mutated NSCLC can be resistant to most approved tyrosine kinase inhibitors (TKIs). The Phase III PAPILLON trial (NCT04538664) demonstrated that amivantamab plus chemotherapy significantly improves progression-free survival (PFS) compared to chemotherapy alone, leading to its approval as a first-line treatment for patients with Ex20ins NSCLC. PAPILLON further evaluated patient-reported outcomes (PROs) and time to symptomatic progression (TTSP).
METHODS: The open-label, multicenter trial randomized 308 treatment-naïve patients with advanced or metastatic NSCLC harboring Ex20ins to receive either amivantamab plus carboplatin-pemetrexed (n = 154) or chemotherapy alone (n = 154). TTSP was defined as the time to onset or worsening of lung cancer-related symptoms necessitating treatment change or clinical intervention, or death. PROs were assessed using the PROMIS PF8c and EORTC QLQ-C30.
RESULTS: At 12 months, 77 % of patients in the amivantamab-chemotherapy arm remained free of symptomatic progression versus 60 % in the chemotherapy arm (HR, 0.67; 95 % CI, 0.46-0.98; p = 0.04). Physical functioning and global health status PROs were maintained in both arms, with a higher proportion of patients treated in the amivantamab-chemotherapy arm reporting stable or improved quality of life at 6 and 12 months.
CONCLUSIONS: Amivantamab plus chemotherapy significantly delays symptomatic progression without compromising health-related quality of life, reinforcing its role as a first-line treatment for Ex20ins-mutated NSCLC.
METHODS: The open-label, multicenter trial randomized 308 treatment-naïve patients with advanced or metastatic NSCLC harboring Ex20ins to receive either amivantamab plus carboplatin-pemetrexed (n = 154) or chemotherapy alone (n = 154). TTSP was defined as the time to onset or worsening of lung cancer-related symptoms necessitating treatment change or clinical intervention, or death. PROs were assessed using the PROMIS PF8c and EORTC QLQ-C30.
RESULTS: At 12 months, 77 % of patients in the amivantamab-chemotherapy arm remained free of symptomatic progression versus 60 % in the chemotherapy arm (HR, 0.67; 95 % CI, 0.46-0.98; p = 0.04). Physical functioning and global health status PROs were maintained in both arms, with a higher proportion of patients treated in the amivantamab-chemotherapy arm reporting stable or improved quality of life at 6 and 12 months.
CONCLUSIONS: Amivantamab plus chemotherapy significantly delays symptomatic progression without compromising health-related quality of life, reinforcing its role as a first-line treatment for Ex20ins-mutated NSCLC.