Exelixis' XL092/ Atezolizumab Shows Encouraging Efficacy, Safety In Heavily Pretreated Cancer Patients

  • Exelixis Inc EXEL announced results from the dose-escalation stage of STELLAR-001, an ongoing phase 1b trial evaluating XL092 as a single agent and in combination with atezolizumab for locally advanced or metastatic solid tumors. 
  • The maximum tolerated dose was determined to be 120 mg, and the recommended dose for the expansion phase is 100 mg for both single-agent XL092 and XL092 in combination with atezolizumab. 
  • Tumor reduction was seen in 71% of patients receiving single-agent XL092 and in 56% of patients receiving XL092 in combination with atezolizumab. 
  • The objective response rate (ORR) was 10% for single-agent XL092 and 4% for XL092 in combination with atezolizumab, with a disease control rate (DCR) of 90% and 74%, respectively. 
  • Confirmed partial responses were observed in four patients treated with single-agent XL092 and one treated with XL092 in combination with atezolizumab.
  • In the 19 patients with clear cell RCC, ORR was 11%, and DCR was 95% with single-agent XL092.
  • XL092 showed a similar reduction in tumor size (RTS). XL092 demonstrated a 71% RTS versus 74% with cabozantinib; a greater than 30% RTS was seen in 15% of patients treated with XL092 versus 18% of those treated with cabozantinib.
  • Price Action: EXEL shares closed at $17.81 on Friday.
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