Think one step ahead for your HCC patients previously treated with sorafenib

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The RESORCE trial evaluated the efficacy and safety of STIVARGA® (regorafenib)1,2

REgorafenib after SORafenib in patients with hepatoCEllular carcinoma (RESORCE) was an international, multicenter, randomized (2:1), double-blind, placebo-controlled phase 3 trial that evaluated the efficacy and safety of STIVARGA in HCC patients with progression following sorafenib (N=573).

  • Patients who permanently discontinued sorafenib due to toxicity or who were unable to tolerate sorafenib doses of 400 mg once daily were ineligible for the trial

RESORCE trial design1,2

Study design information. Visit hcp.stivarga-us.com to see full safety and Prescribing Information, including Boxed Warning.

Primary endpoint1:

  • Overall survival (OS), analyzed by intention to treat

Secondary endpoints1,2:

  • Progression-free survival (PFS), time to progression, overall response rate (ORR; patients with complete response [CR] or partial response [PR]), disease control rate (DCR; patients with CR, PR, or stable disease [SD] for ≥6 weeks)
    • Analyzed by intention to treat; assessed using modified Response Evaluation Criteria In Solid Tumors (mRECIST) and RECIST 1.1

Tertiary endpoint2:

  • Duration of response

Patients in the RESORCE trial had good performance status and preserved liver function1,2

Baseline patient characteristics were similar between each arm1,2

Baseline characteristics1,2

 STIVARGA
(n=379) %
Placebo
(n=194) %
Sex  
Male8888
Female1212
Race  
White3635
Asian4140
Black21
Other/Not reported2124
Median age, years6462
Eastern Cooperative Oncology Group performance status (ECOG PS)  
06567
13533
Macrovascular invasion (MVI)2928
Extrahepatic disease (EHD)7076
MVI and/or EHD8084
Alpha-fetoprotein (AFP) ≥400 ng/mL4345
Child-Pugh§  
A9897
B13
BCLC stage  
A<10
B1411
C8689
Liver cirrhosis (investigator assessed)7574
Etiology of HCCII  
Hepatitis B3838
Alcohol use2428
Hepatitis C2121
Unknown1716
Nonalcoholic steatohepatitis77
Other75
Duration of sorafenib treatment, months7.8 (4.2-14.5)7.8 (4.4-14.7)

Results from RESORCE represent a significant advance in treatment for HCC patients previously treated with sorafenib1

10.6-month median OS achieved with STIVARGA vs 7.8 months with placebo1,2

Median OS in RESORCE1,2

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

37% reduction in risk of
death with STIVARGA

HR: 0.63
(95% CI, 0.50-0.79)
P=<0.0001

37% reduction in risk of death with STIVARGA

HR: 0.63
(95% CI, 0.50-0.79)
P=<0.0001

STIVARGA OS based on exploratory, preplanned patient subgroup analyses1

Subgroup analysis in RESORCE1

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

STIVARGA more than doubled PFS vs placebo1,2

3.1-month median PFS achieved with STIVARGA vs 1.5 months with placebo

PFS in RESORCE (mRECIST)1,2

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

54% reduction in risk of
progression or death
with STIVARGA

HR: 0.46
(95% CI, 0.37-0.56)
P<0.0001

54% reduction in risk of
progression or death
with STIVARGA

HR: 0.46
(95% CI, 0.37-0.56)
P<0.0001

Reduction in risk of progression or death with STIVARGA was consistent when assessed by RECIST 1.12

  • 3.4-month (95% CI, 2.9-4.2) median PFS achieved with STIVARGA vs 1.5 months (95% CI, 1.4-1.5 with placebo (HR: 0.43; 95% CI, 0.35-0.52) (RECIST 1.1)
    • Number of progressions or deaths: 288 of 379 (76%) in the STIVARGA arm; 184 of 194 (95%) in the placebo arm

Break through response barriers with STIVARGA1-3

Tumor response rates in RESORCE1-3

 STIVARGA,
(n=379, %)
Placebo,
(n=194, %)
Assessed using mRECIST  
DCR6536
ORR (95% CI)11 (8-14)4 (2-8)
CR10
PR104
SD5432
Assessed using RECIST 1.1  
DCR6635
ORR (95% CI)7 (4-10)3 (1-6)
CR00
PR73
SD5932

DCR, CR + PR + SD; ORR, CR + PR.

Duration of disease response, assessed using mRECIST3

  • Median duration of response in patients with a complete or partial response was 3.5 months in the STIVARGA arm vs 2.7 months in the placebo arm3
  • Median duration of stable disease was 5.5 months in the STIVARGA arm vs 3.1 months in the placebo arm3