Enhanced Versus Standard Dermatologic Management With Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC: The COCOON Global Randomized Controlled Trial.
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Cho Byoung Chul, Li Weimin, Spira Alexander I, Sauder Maxwell, Feldman Jill, Bozorgmehr Farastuk, Mak Milena, Smith Janellen, Voon Pei Jye, Liu Baogang, Tian Panwen, Tan Jiunn-Liang, Yang Cheng-Ta, Shih Jin-Yuan, Karadurmus Nuri, Cundom Juan Esteban, Bertollo Glaucio, Cicin Irfan, Nieva Jorge, Ortega-Granados Ana Laura, Tomasini Pascale, Nguyen Danny, Felip Enriqueta, Schuchard Julia, Murphy Sean P, Anderson Bailey G, Romero Tonatiuh, Xia Yichuan, Sheng Shubin, Bauml Joshua M, Mahadevia Parthiv J, Kam Julian, Nematian-Samani Mehregan, Simoes Jairo, Wildgust Mark, Girard Nicolas
Аннотация
METHODS: In the phase 2 COCOON study (NCT06120140), participants with previously untreated, EGFR-mutant, locally advanced or metastatic NSCLC received intravenous amivantamab plus oral lazertinib and were randomized 1:1 to enhanced dermatologic management (COCOON DM) or standard of care (SoC DM) per local guidelines. COCOON DM included oral doxycycline or minocycline (100 mg twice daily; weeks 1-12), clindamycin 1% (on scalp daily; weeks 13-52), chlorhexidine 4% (on fingernails and toenails daily), and ceramide-based moisturizer (on body and face at least daily). Primary end point was incidence of grade 2 or higher dermatologic AEs of interest (DAEIs) by week 12.
RESULTS: In total, 201 participants were randomized (99 to COCOON DM and 102 to SoC DM). At a median follow-up of 7.1 months, COCOON DM demonstrated significant reduction in the primary end point versus SoC DM (42% versus 75%; OR, 0.24; 95% confidence interval, 0.13-0.45; p < 0.0001). By week 12, the largest benefit with COCOON DM was observed in DAEIs involving the face and body (excludes paronychia; 26% versus 60%; p < 0.0001) and DAEIs involving the scalp (10% versus 26%; p = 0.0049). This benefit was maintained at 6 months, with significant reductions of DAEIs involving face, body, and scalp (excluding paronychia). Patient-reported outcomes favored COCOON DM, indicating reduced impact of dermatologic symptoms on QoL.
CONCLUSION: An uncomplicated, widely available, prophylactic regimen (COCOON DM) reduced the incidence of DAEIs with amivantamab-lazertinib and the impact of symptoms on QoL.