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Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study

Park, Keunchil ; Haura, Eric B ; Leighl, Natasha B ; Mitchell, Paul ; Shu, Catherine A ; Girard, Nicolas ; Viteri, Santiago ; Han, Ji-Youn ; Kim, Sang-We ; Lee, Chee Khoon ; Sabari, Joshua K ; Spira, Alexander I ; Yang, Tsung-Ying ; Kim, Dong-Wan ; Lee, Ki Hyeong ; Sanborn, Rachel E ; Trigo, José ; Goto, Koichi ; Lee, Jong-Seok ; Yang, James Chih-Hsin ; Govindan, Ramaswamy ; Bauml, Joshua M ; Garrido, Pilar ; Krebs, Matthew G ; Reckamp, Karen L ; Xie, John ; Curtin, Joshua C ; Haddish-Berhane, Nahor ; Roshak, Amy ; Millington, Dawn ; Lorenzini, Patricia ; Thayu, Meena ; Knoblauch, Roland E ; Cho, Byoung Chul

Journal of clinical oncology, 2021-10, Vol.39 (30), p.3391-3402 [Periódico revisado por pares]

United States: Wolters Kluwer Health

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Título:
Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study
Autor: Park, Keunchil ; Haura, Eric B ; Leighl, Natasha B ; Mitchell, Paul ; Shu, Catherine A ; Girard, Nicolas ; Viteri, Santiago ; Han, Ji-Youn ; Kim, Sang-We ; Lee, Chee Khoon ; Sabari, Joshua K ; Spira, Alexander I ; Yang, Tsung-Ying ; Kim, Dong-Wan ; Lee, Ki Hyeong ; Sanborn, Rachel E ; Trigo, José ; Goto, Koichi ; Lee, Jong-Seok ; Yang, James Chih-Hsin ; Govindan, Ramaswamy ; Bauml, Joshua M ; Garrido, Pilar ; Krebs, Matthew G ; Reckamp, Karen L ; Xie, John ; Curtin, Joshua C ; Haddish-Berhane, Nahor ; Roshak, Amy ; Millington, Dawn ; Lorenzini, Patricia ; Thayu, Meena ; Knoblauch, Roland E ; Cho, Byoung Chul
Assuntos: Adult ; Aged ; Aged, 80 and over ; Antibodies, Bispecific - administration & dosage ; Antibodies, Bispecific - adverse effects ; Antibodies, Bispecific - pharmacokinetics ; Antineoplastic Agents, Immunological - administration & dosage ; Antineoplastic Agents, Immunological - adverse effects ; Antineoplastic Agents, Immunological - pharmacokinetics ; Carcinoma, Non-Small-Cell Lung - drug therapy ; Carcinoma, Non-Small-Cell Lung - genetics ; Carcinoma, Non-Small-Cell Lung - secondary ; Diarrhea - chemically induced ; Disease Progression ; Drug Eruptions - etiology ; ErbB Receptors - genetics ; Exons ; Female ; Humans ; Hypokalemia - chemically induced ; Injection Site Reaction - etiology ; Lung Neoplasms - drug therapy ; Lung Neoplasms - genetics ; Lung Neoplasms - pathology ; Male ; Middle Aged ; Mutagenesis, Insertional ; Neutropenia - chemically induced ; Organoplatinum Compounds - therapeutic use ; ORIGINAL REPORTS ; Paronychia - chemically induced ; Progression-Free Survival ; Pulmonary Embolism - chemically induced ; Retreatment
É parte de: Journal of clinical oncology, 2021-10, Vol.39 (30), p.3391-3402
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
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Descrição: Non-small-cell lung cancer (NSCLC) with epidermal growth factor receptor ( ) exon 20 insertion (Exon20ins) mutations exhibits inherent resistance to approved tyrosine kinase inhibitors. Amivantamab, an EGFR-MET bispecific antibody with immune cell-directing activity, binds to each receptor's extracellular domain, bypassing resistance at the tyrosine kinase inhibitor binding site. CHRYSALIS is a phase I, open-label, dose-escalation, and dose-expansion study, which included a population with Exon20ins NSCLC. The primary end points were dose-limiting toxicity and overall response rate. We report findings from the postplatinum Exon20ins NSCLC population treated at the recommended phase II dose of 1,050 mg amivantamab (1,400 mg, ≥ 80 kg) given once weekly for the first 4 weeks and then once every 2 weeks starting at week 5. In the efficacy population (n = 81), the median age was 62 years (range, 42-84 years); 40 patients (49%) were Asian, and the median number of previous lines of therapy was two (range, 1-7). The overall response rate was 40% (95% CI, 29 to 51), including three complete responses, with a median duration of response of 11.1 months (95% CI, 6.9 to not reached). The median progression-free survival was 8.3 months (95% CI, 6.5 to 10.9). In the safety population (n = 114), the most common adverse events were rash in 98 patients (86%), infusion-related reactions in 75 (66%), and paronychia in 51 (45%). The most common grade 3-4 adverse events were hypokalemia in six patients (5%) and rash, pulmonary embolism, diarrhea, and neutropenia in four (4%) each. Treatment-related dose reductions and discontinuations were reported in 13% and 4% of patients, respectively. Amivantamab, via its novel mechanism of action, yielded robust and durable responses with tolerable safety in patients with Exon20ins mutations after progression on platinum-based chemotherapy.
Editor: United States: Wolters Kluwer Health
Idioma: Inglês

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Amivantamab in EGFR Exon 20 Insertion-Mutated Non-Small-Cell Lung Cancer Progressing on Platinum Chemotherapy: Initial Results From the CHRYSALIS Phase I Study

United States: Wolters Kluwer Health

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