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Brief Report: Safety and Antitumor Activity of Alectinib Plus Atezolizumab From a Phase 1b Study in Advanced ALK-Positive NSCLC.
Kim, Dong-Wan; Gadgeel, Shirish; Gettinger, Scott N; Riely, Gregory J; Oxnard, Geoffrey R; Mekhail, Tarek; Schmid, Peter; Dowlati, Afshin; Heist, Rebecca S; Wozniak, Antoinette J; Singh, Jatinder; Cha, Edward; Spahn, Jessica; Ou, Sai-Hong Ignatius.
Afiliación
  • Kim DW; Department of Internal Medicine, Seoul National University College of Medicine and Seoul National University Hospital, Seoul, South Korea.
  • Gadgeel S; Department of Internal Medicine, Henry Ford Cancer Institute, Henry Ford Health System, Detroit, Michigan.
  • Gettinger SN; Department of Medicine (Medical Oncology), Yale School of Medicine, New Haven, Connecticut.
  • Riely GJ; Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
  • Oxnard GR; Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.
  • Mekhail T; AdventHealth Cancer Institute, Orlando, Florida.
  • Schmid P; Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London, United Kingdom.
  • Dowlati A; Division of Hematology and Oncology, University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, Ohio.
  • Heist RS; Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
  • Wozniak AJ; UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, Pennsylvania.
  • Singh J; Genentech, Inc., South San Francisco, California.
  • Cha E; Genentech, Inc., South San Francisco, California.
  • Spahn J; Genentech, Inc., South San Francisco, California.
  • Ou SI; University of California Irvine School of Medicine, Orange, California.
JTO Clin Res Rep ; 3(8): 100367, 2022 Aug.
Article en En | MEDLINE | ID: mdl-35875467
Introduction: Alectinib is a preferred first-line treatment option for advanced ALK-positive NSCLC. Combination regimens of alectinib with immune checkpoint inhibitors are being evaluated for synergistic effects. Methods: Adults with treatment-naive, stage IIIB/IV, or recurrent ALK-positive NSCLC were enrolled into a two-stage phase 1b study. Patients received alectinib 600 mg (twice daily during cycle 1 and throughout each 21-d cycle thereafter) plus atezolizumab 1200 mg (d8 of cycle 1 and then d1 of each 21-d cycle). Primary objectives were to evaluate safety and tolerability of alectinib plus atezolizumab. Secondary objectives included assessments of antitumor activity. Results: In total, 21 patients received more than or equal to 1 dose of alectinib or atezolizumab. As no dose-limiting toxicities were observed in stage 1 (n = 7), the starting dose and schedule were continued into stage 2 (n = 14). Median duration of follow-up was 29 months (range: 1-39). Grade 3 treatment-related adverse events occurred in 57% of the patients, most often rash (19%). No grade 4 or 5 treatment-related adverse events were reported. Confirmed objective response rate was 86% (18 of 21; 95% confidence interval [CI]: 64-97). Median progression-free survival was not estimable (NE) (95% CI: 13 mo-NE), neither was median overall survival (95% CI: 33 mo-NE). Conclusions: The combination of alectinib and atezolizumab is feasible, but increased toxicity was found compared with the individual agents. With small sample sizes and relatively short follow-up, definitive conclusions regarding antitumor activity cannot be made.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: JTO Clin Res Rep Año: 2022 Tipo del documento: Article País de afiliación: Corea del Sur Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: JTO Clin Res Rep Año: 2022 Tipo del documento: Article País de afiliación: Corea del Sur Pais de publicación: Estados Unidos