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
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 medication | 131 (26) | 76 (30) |
Any antineoplastic or immunomodulation agent | 130 (26) | 74 (29) |
Systemic anticancer treatment during CORRECT trial follow-up | STIVARGA, n (%) (n=505) | Placebo, n (%) (n=255) |
---|---|---|
Patients with ≥1 medication | 131 (26) | 76 (30) |
Any antineoplastic or immunomodulation agent | 130 (26) | 74 (29) |
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
- 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, y | 61 | 61 |
Sex | ||
Male | 62% | 60% |
Female | 38% | 40% |
Disease site | ||
Colon | 64% | 68% |
Rectum | 30% | 27% |
Both | 6% | 5% |
Historical KRAS status | ||
Mutated | 54% | 62% |
Race | ||
White | 78% | 79% |
Black or African American | 1% | 3% |
Asian | 15% | 14% |
Other or not specified | 6% | 4% |
ECOG performance status | ||
ECOG PS 0 | 52% | 57% |
ECOG PS 1 | 48% | 43% |