Harness the power of STIVARGA® (regorafenib)

The only approved option for gastrointestinal stromal tumor (GIST) after treatment with imatinib and sunitinib1,2

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Harness the proven efficacy of STIVARGA to significantly improve progression-free survival in previously treated patients with GIST1,2

In the pivotal GRID trial, STIVARGA demonstrated statistically significant improvement in PFS in previously treated patients with GIST1,2

Significant improvement in PFS1,2

STIVARGA (regorafenib) efficacy chart. Visit hcp.stivarga-us.com to see full safety and Prescribing Information, including Boxed Warning.

73% reduction in risk of
disease progression
in GRID

HR: 0.27
(95% CI, 0.19-0.39) P<0.0001

73% reduction in risk of
disease progression
in GRID

HR: 0.27
(95% CI, 0.19-0.39) P<0.0001

  • 82 of 133 STIVARGA patients (62%) vs 63 of 66 placebo patients (96%) experienced disease progression or died2
  • At the time of disease progression as assessed by central review, the study blind was broken and all patients were offered the opportunity to take STIVARGA at the investigator’s discretion. Cross-over to open-label STIVARGA occurred in 58 (88%) placebo-treated patients after disease progression2
  • There was no statistically significant difference in OS at the final OS analysis, conducted at 162 OS events2
  • DCR was 52.6% with STIVARGA (70/133 patients) vs 9.1% with placebo (6/66 patients)1
    • DCR was a secondary endpoint
    • DCR is defined as the rate of complete response or partial response plus stable disease lasting for ≥12 weeks1

GRID trial study design

STIVARGA was studied in patients with a high unmet need following disease progression on 2 prior TKIs in GRID1

The GRID trial: A randomized, double-blind study in patients who had been previously treated with imatinib and sunitinib1,2

STIVARGA (regorafenib) study design. Visit hcp.stivarga-us.com to see full safety and Prescribing Information, including Boxed Warning.
  • The GRID trial was a phase III, randomized, placebo-controlled trial in patients with metastatic or unresectable GIST who had progressed after failure of at least imatinib and sunitinib or after intolerance to imatinib1,2
  • Primary endpoint: (PFS)2
    • Based on disease assessment by independent radiological review using modified RECIST 1.1. criteria, in which lymph nodes and bone lesions were not target lesions and progressively growing new tumor nodule within a pre-existing tumor mass was progression
  • Key secondary endpoint: overall survival (OS). Secondary endpoints included OS, time to progression, objective response rate, and disease control rate (DCR; defined as rate of complete response or partial response plus stable disease lasting for ≥12 weeks), safety, and tolerability1,2
  • At progression, patients on placebo could cross over to receive open-label STIVARGA, and patients originally assigned to the STIVARGA group could continue to receive open-label therapy2

GRID trial patient population

Patient population with a high unmet need following the failure of 2 prior TKIs. Demographics were similar between arms.1

GRID patient population1

  STIVARGA (n=133) Placebo (n=66)
Median age, y 60 61
Sex    
Male 64% 64%
Female 36% 36%
Ethnic group    
White 68% 68%
Black or African American 0% 2%
Asian 26% 24%
Not reported or missing 7% 6%
Performance status    
ECOG 0 55% 56%
ECOG 1 45% 44%