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Phase II Trial of Pembrolizumab and Anti-CD3 x Anti-HER2 Bispecific Antibody-Armed Activated T Cells in Metastatic Castration-Resistant Prostate Cancer.
Vaishampayan, Ulka N; Thakur, Archana; Chen, Wei; Deol, Abhinav; Patel, Meera; Dobson, Kimberlee; Dickow, Brenda; Schalk, Dana; Schienschang, Amy; Whitaker, Sarah; Polend, Amanda; Fontana, Joseph A; Heath, Elisabeth I; Lum, Lawrence G.
Afiliación
  • Vaishampayan UN; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Thakur A; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
  • Chen W; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Deol A; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Patel M; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Dobson K; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Dickow B; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Schalk D; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
  • Schienschang A; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
  • Whitaker S; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
  • Polend A; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
  • Fontana JA; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Heath EI; Karmanos Cancer Center, Wayne State University, Detroit, Michigan.
  • Lum LG; Emily Couric Cancer Center, University of Virginia, Charlottesville, Virginia.
Clin Cancer Res ; 29(1): 122-133, 2023 01 04.
Article en En | MEDLINE | ID: mdl-36255393
PURPOSE: A phase II study was conducted to evaluate the safety and efficacy of the combination of HER2 bispecific antibody (HER2Bi)-armed activated T cells (HER2 BAT) and programmed death 1 inhibitor, pembrolizumab. PATIENTS AND METHODS: Patients with metastatic castration-resistant prostate cancer (mCRPC) with 0 to 1 performance status and normal liver, kidney, and marrow function, pre- or post-docetaxel chemotherapy were eligible. Primary endpoint was 6-month progression-free survival (PFS). Peripheral blood mononuclear cells were obtained by a single apheresis, shipped to University of Virginia, activated with OKT3 and expanded for 14 days in IL2, harvested, and armed with HER2Bi and cryopreserved. HER2 BATs were infused twice weekly for 4 weeks and pembrolizumab was administered every 21 days for a maximum duration of 6 months starting 1 to 3 weeks prior to HER2 BATs infusion. RESULTS: Fourteen patients were enrolled with a median age of 69 (range 57-82 years) and median PSA of 143.4 (range 8.2-4210 ng/dL). Two patients had peritoneal metastases, 1 had lymph node (LN) only metastases and 11 had bone metastases of which 7 had bone and LN metastases. All were pretreated with androgen receptor axis targeted agents and 7 (50%) had prior docetaxel chemotherapy. The toxicities were grade1-2 infusion reactions with fever, chills, headaches, nausea and/or myalgias. Primary endpoint of 6 month PFS was achieved in 5 of 14 patients (38.5%; 95% confidence interval, 19.5%-76.5%). Median PFS was 5 months and median survival was 31.6 months. CONCLUSIONS: The safety and promising efficacy makes this combination worthy of future investigation in mCRPC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Próstata Resistentes a la Castración Límite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Neoplasias de la Próstata Resistentes a la Castración Límite: Aged / Aged80 / Humans / Male / Middle aged Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article Pais de publicación: Estados Unidos