Harness the power of STIVARGA® (regorafenib)

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Harness the proven efficacy of STIVARGA to maximize potential overall survival (OS) for your previously treated patients with mCRC

In the pivotal CORRECT trial, STIVARGA demonstrated a median OS of 6.4 months vs 5.0 months with placebo for previously treated patients with mCRC1

Significant improvement in OS1*

Line graph showing OS results from STIVARGA (regorafenib) CORRECT trial and highlighting a 23% reduction in the risk of death.

23% reduction in the risk of
death with STIVARGA1

HR: 0.77
(95% CI, 0.64-0.94) P=0.0102

23% reduction in the risk of
death with STIVARGA1

HR: 0.77
(95% CI, 0.64-0.94) P=0.0102

CORRECT (COloRectal cancer treated with REgorafenib or plaCebo after failure of standard Therapy) was a large, international, placebo-controlled, double-blind, randomized (2:1), phase 3 trial that evaluated the efficacy and safety of STIVARGA in patients with mCRC who had progressed after all approved standard therapies (N=760).1, 2

  • STIVARGA improved OS in CORRECT, which included patients with historically collected KRAS status (N=729)1
    • Historical KRAS status was assessed (59% mutant, 41% KRAS wild-type)
  • There were 275 deaths out of 505 patients treated with STIVARGA (55%) vs 157 deaths out of 255 patients treated with placebo (62%)1

Cytotoxic therapy in CORRECT

In CORRECT, patients were able to receive cytotoxic therapy following treatment with STIVARGA2, 3

CORRECT trial: 26% of patients received cytotoxic therapy after STIVARGA2, 3

 STIVARGA, n (%)Placebo, n (%)
Systemic anticancer treatment during CORRECT trial follow-up(n=505)(n=255)
Patients with ≥1 medication131 (26)76 (30)
Any antineoplastic or immunomodulation agent130 (26)74 (29)
Systemic anticancer treatment during CORRECT trial follow-upSTIVARGA, n (%)
(n=505)
Placebo, n (%)
(n=255)
Patients with ≥1 medication131 (26)76 (30)
Any antineoplastic or immunomodulation agent130 (26)74 (29)

STIVARGA significantly improved progression-free survival (PFS)

In the pivotal CORRECT trial, STIVARGA demonstrated a 51% reduction in the risk of disease progression or death1, 2

Significant improvement in PFS1, 2

Line graph showing PFS results from STIVARGA (regorafenib) CORRECT trial and highlighting a 51% reduction in the risk of disease progression or death.

51% reduction in the risk of
disease progression or death in CORRECT1, 2

HR: 0.49
(95% CI, 0.42-0.58) P<0.0001

51% reduction in the risk of
disease progression or death in CORRECT1,2

HR: 0.49
(95% CI, 0.42-0.58) P<0.0001

Disease control rate (DCR)

Disease control with 41% of patients treated with STIVARGA vs 15% with placebo2

  • DCR included a 41% stable disease rate and a 1% partial response rate in the STIVARGA arm (n=207/505) vs a 15% stable disease rate and a 0.4% partial response rate in the placebo arm (n=38/255)2
    • Disease control is defined as proportion of patients with a best response of complete or partial response or stable disease; assessment of stable disease had to be made at least 6 weeks after randomization

CORRECT trial study design

Multicenter, randomized, double-blind, placebo-controlled, phase 3 trial2

A large, international, phase 3, double-blind, randomized trial involving 760 patients1, 2

CORRECT trial design diagram. Patients intolerant to standard therapies were randomly (2:1 ratio) treated with Stivarga (regorafenib) or placebo + BSC. Treatment continued until disease progression of unacceptable toxicity. Tumor assessed every 8 weeks by RECIST 1.1 criteria.
  • Study arms abbreviated as STIVARGA and placebo throughout this website
  • Stratification: Prior treatment with anti-VEGF drugs, time from diagnosis of mCRC, and geographical region2
  • Treatment continued until disease progression or unacceptable toxicity2
  • Tumors were assessed every 8 weeks by RECIST 1.1 criteria2
  • No crossover between treatment groups was allowed2

CORRECT trial patient population

Most demographics and disease characteristics were similar between arms in the CORRECT trial

Baseline characteristics2

 STIVARGA 
(n=505)
Placebo 
(n=255)
Median age, y6161
Sex  
Male62%60%
Female38%40%
Disease site  
Colon64%68%
Rectum30%27%
Both6%5%
Historical KRAS status  
Mutated54%62%
Race  
White78%79%
Black or African American1%3%
Asian15%14%
Other or not specified6%4%
ECOG performance status  
ECOG PS 052%57%
ECOG PS 148%43%