Efficacy of TORISEL

Significant overall survival benefit as first-line therapy¹

TORISEL demonstrated a statistically significant 49% increase in median overall survival (OS) compared with interferon-alpha (IFN-α) (P=0.0078*).¹

Overall survival results were achieved with TORISEL in patients regardless of²

• Clear-cell or non-clear-cell tumor histology
• Presence or absence of prior nephrectomy

Secondary end points^1,3

• TORISEL demonstrated a significant 77% increase in median progression-free survival (PFS)^ll compared with IFN-α (P=0.0001^¶)
  • TORISEL and IFN-α demonstrated median PFS of 5.5 (95% CI, 3.9, 7.0) months and 3.1 (2.2, 3.8)
    months, respectively (Hazard Ratio [95% CI] = 0.66 [0.53, 0.81])
• TORISEL showed no significant difference in overall response rate (ORR^#) compared with IFN-α (P=0.1232^¶**)
  • TORISEL and IFN-α demonstrated ORRs of 8.6% (95% CI, 4.8, 12.4) and 4.8% (1.9, 7.8), respectively

Duration of treatment¹

The median duration of treatment in the TORISEL arm was 17 weeks (range 1-126 weeks)
The median duration of treatment in the IFN-α arm was 8 weeks (range 1-124 weeks)

ll Time from randomization to disease progression or death, censored at the last tumor evaluation date. The
   evaluation of PFS was based on blinded independent radiologic assessment of tumor response using RECIST-
   based criteria.
¶ Not adjusted for multiple comparisons.
# Percent of patients who had confirmed complete or partial response as their best response to treatment. The
   evaluation of ORR was based on blinded independent radiologic assessment of tumor response using RECIST-
   based criteria.
** Based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and region.

 

Clinical trials

• Read more about TORISEL Clinical Trial Design and Results
• Participate in an interactive review of the published TORISEL phase 3 clinical trial

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