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Efficacy and Safety of Adagrasib plus Cetuximab in Patients with KRASG12C-Mutated Metastatic Colorectal Cancer.
Yaeger, Rona; Uboha, Nataliya V; Pelster, Meredith S; Bekaii-Saab, Tanios S; Barve, Minal; Saltzman, Joel; Sabari, Joshua K; Peguero, Julio A; Paulson, Andrew Scott; Jänne, Pasi A; Cruz-Correa, Marcia; Anderes, Kenna; Velastegui, Karen; Yan, Xiaohong; Der-Torossian, Hirak; Klempner, Samuel J; Kopetz, Scott E.
Afiliação
  • Yaeger R; Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Uboha NV; Division of Hematology and Oncology, Department of Medicine, University of Wisconsin, Madison, Wisconsin.
  • Pelster MS; Sarah Cannon Research Institute, Tennessee Oncology, Nashville, Tennessee.
  • Bekaii-Saab TS; Department of Medical Oncology and Hematology, Mayo Clinic, Scottsdale, Arizona.
  • Barve M; Mary Crowley Cancer Research Center, Dallas, Texas.
  • Saltzman J; Department of Hematology and Medical Oncology, Cleveland Clinic, Cleveland, Ohio.
  • Sabari JK; Division of Medical Oncology, Perlmutter Cancer Center, New York University Langone Health, New York, New York.
  • Peguero JA; Department of Research, Oncology Consultants PA, Houston, Texas.
  • Paulson AS; Department of Medical Oncology, Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas.
  • Jänne PA; Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
  • Cruz-Correa M; PanOncology Trials, San Juan, Puerto Rico.
  • Anderes K; Mirati Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb Company, San Diego, California.
  • Velastegui K; Mirati Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb Company, San Diego, California.
  • Yan X; Mirati Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb Company, San Diego, California.
  • Der-Torossian H; Mirati Therapeutics, a wholly owned subsidiary of Bristol Myers Squibb Company, San Diego, California.
  • Klempner SJ; Division of Hematology-Oncology, Massachusetts General Cancer Center, Boston, Massachusetts.
  • Kopetz SE; Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cancer Discov ; 14(6): 982-993, 2024 Jun 03.
Article em En | MEDLINE | ID: mdl-38587856
ABSTRACT
Adagrasib, an irreversible, selective KRASG12C inhibitor, may be an effective treatment in KRASG12C-mutated colorectal cancer, particularly when combined with an anti-EGFR antibody. In this analysis of the KRYSTAL-1 trial, patients with previously treated KRASG12C-mutated unresectable or metastatic colorectal cancer received adagrasib (600 mg twice daily) plus cetuximab. The primary endpoint was objective response rate (ORR) by blinded independent central review. Ninety-four patients received adagrasib plus cetuximab. With a median follow-up of 11.9 months, ORR was 34.0%, disease control rate was 85.1%, and median duration of response was 5.8 months (95% confidence interval [CI], 4.2-7.6). Median progression-free survival was 6.9 months (95% CI, 5.7-7.4) and median overall survival was 15.9 months (95% CI, 11.8-18.8). Treatment-related adverse events (TRAEs) occurred in all patients; grade 3-4 in 27.7% and no grade 5. No TRAEs led to adagrasib discontinuation. Exploratory analyses suggest circulating tumor DNA may identify features of response and acquired resistance.

SIGNIFICANCE:

Adagrasib plus cetuximab demonstrates promising clinical activity and tolerable safety in heavily pretreated patients with unresectable or metastatic KRASG12C-mutated colorectal cancer. These data support a potential new standard of care and highlight the significance of testing and identification of KRASG12C mutations in patients with colorectal cancer. This article is featured in Selected Articles from This Issue, p. 897.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Colorretais / Protocolos de Quimioterapia Combinada Antineoplásica / Proteínas Proto-Oncogênicas p21(ras) / Cetuximab / Mutação Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias Colorretais / Protocolos de Quimioterapia Combinada Antineoplásica / Proteínas Proto-Oncogênicas p21(ras) / Cetuximab / Mutação Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Ano de publicação: 2024 Tipo de documento: Article