RESUMEN
BACKGROUND: We hypothesized that avelumab plus axitinib could improve clinical outcomes in patients with advanced non-small-cell lung cancer (NSCLC) or urothelial carcinoma (UC). PATIENTS AND METHODS: We enrolled previously treated patients with advanced or metastatic NSCLC, or untreated, cisplatin-ineligible patients with advanced or metastatic UC. Patients received avelumab 800 mg every 2 weeks (Q2W) and axitinib 5 mg orally two times daily. The primary endpoint was objective response rate (ORR). Immunohistochemistry was used to assess programmed death-ligand 1 (PD-L1) expression (SP263 assay) and the presence of CD8+ T cells (clone C8/144B). Tumor mutational burden (TMB) was assessed by whole-exome sequencing. RESULTS: A total of 61 patients were enrolled and treated (NSCLC, n = 41; UC, n = 20); 5 remained on treatment at data cut-off (26 February 2021). The confirmed ORR was 31.7% in the NSCLC cohort and 10.0% in the UC cohort (all partial responses). Antitumor activity was observed irrespective of PD-L1 expression. In exploratory subgroups, ORRs were higher in patients with higher (≥median) CD8+ T cells in the tumor. ORRs were higher in patients with lower TMB (Asunto(s)
Carcinoma de Pulmón de Células no Pequeñas
, Carcinoma de Células Transicionales
, Neoplasias Pulmonares
, Neoplasias de la Vejiga Urinaria
, Humanos
, Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico
, Carcinoma de Pulmón de Células no Pequeñas/patología
, Axitinib/farmacología
, Axitinib/uso terapéutico
, Cisplatino/farmacología
, Cisplatino/uso terapéutico
, Neoplasias Pulmonares/tratamiento farmacológico
, Neoplasias Pulmonares/patología
, Anticuerpos Monoclonales/efectos adversos