New Reference: Afatinib for NSCLC with Uncommon EGFR Mutations

Open-label, randomized, multicenter phase 3 trial (ACHILLES/TORG1834)

Previously untreated non-squamous NSCLC with sensitizing uncommon EGFR mutations (excluding exon20ins and T790M)

Afatinib 30 or 40 mg daily vs. platinum (cisplatin or carboplatin) + pemetrexed followed by maintenance pemetrexed

ORR: 61.4% vs. 47.1%

CR: Not reported

mDoR: 10.6 mos vs. 5.6 mos (HR: 0.35 [0.16-0.76])

mPFS: 10.6 mos vs. 5.7 mos (HR: 0.42 [0.25-0.71])

mOS: Not mature

Grade ≥3 AEs: 44% vs. 37%

Common AEs with afatinib: Diarrhea, rash, paronychia

Common AEs with chemo: Appetite loss (43%), nausea (34%), myelosuppression

Treatment-related discontinuations: 16% vs. 5.7%

Miura S,Tanaka H,Misumi T Pragmatic Randomized Study of Afatinib Versus Chemotherapy for Patients With Non–Small Cell Lung Cancer With Uncommon Epidermal Growth Factor Receptor Mutations: ACHILLES/TORG1834

Reviewed by Ulas D. Bayraktar, MD on Apr 22, 2025