Efficacy
Study Design
FRESCO-2 was a global, randomized, double-blind, multicenter phase 3 study, evaluating the efficacy and safety of Fruzaqla + best supportive care (BSC) vs. Placebo + BSC.1,2
Demographics
Fruzaqla was studied in a robust clinical trial that included a heterogeneous patient population:1,2
Adapted from Dasari et al, 2023.
aECOG PS scores range from 0 to 5, with 0 indicating fully active and higher scores indicating greater disability.2
bDuration of metastatic disease=(date of randomization – date of diagnosis of metastatic disease)/30.4375.2
cMeasurable disease was locally assessed by Response Evaluation Criteria in Solid Tumours
(RECIST; version 1.1)
Overall Survival
Fruzaqla+ BSC demonstrated significant overall survival(OS) benefit1,2
Nearly 3-month improvement in median OS vs. placebo+BSC.
Adapted from Dasari et al., 2023
Overall Survival – Subgroup Analysis
Overall survival benefit was consistent across most prespecified subgroups, regardless of duration of metastatic disease, RAS status, prior types of therapy and presence of liver metastases2
Adapted from Dasari et al., 2023
This study was not powered to show significance in OS across these specified groups.
Progression-free Survival
Fruzaqla +BSC demonstrated more than doubled median progression-free survival(PFS) vs. placebo+BSC1,2.
Adapted from Dasari et al., 2023
Progression-free Survival - Subgroup Analysis
Fruzaqla +BSC demonstrated PFS benefit across a majority of prespecified subgroups, regardless of duration of metastatic disease, RAS status, prior types of therapy and presence of liver metastases2
Adapted from Dasari et al., 2023
This study was not powered to show statistical significance in PFS across these specified groups.
Disease Control Rate
More than half of the patients achieved at least disease stabilization with Fruzaqla + BSC2.
(adjusted difference 39%, 95% CI 32.8–46.0; p<0.0001)
* Disease control was defined as the proportion of patients with a best overall response of confirmed complete response, partial response, or stable disease for ≥7 weeks.
This study was not powered to show statistical significance in disease control rate.
Quality of Life
Patients treated with Fruzaqla + BSC experienced delayed or maintained time to deterioration vs placebo+BSC3
Adapted from Sobrero et al., 2023
The FRESCO-2 clinical trial evaluated quality of life for patients living with metastatic colorectal cancer treated with Fruzaqla. Based on predefined MIDs for QLQ-C30 global health status, QLQ-C30 subscales, and EQ-5D-5L, the median TTD and the corresponding HR for all scales and subscales showed a trend favoring Fruzaqla.
This study was not powered to show statistical significance in QoL.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
References:
1. Fruzaqla EU Summary of Product Characteristics (SmPC) latest approved version.
2. Dasari A, Lonardi S, Garcia-Carbonero R, et al; FRESCO-2 Study Investigators. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, phase 3 study. Lancet. 2023;402(10395):41-53.
3. Sobrero A, Dasari A, Lonardi S, et al. Health-related quality of life (HRQoL) associated with fruquintinib in the global phase 3, randomized, double-blind, placebo-controlled FRESCO-2 study. Poster presented at: ASCO Gastrointestinal Cancer Symposium; January 19-21, 2023; San Francisco, CA.
Abbreviations:
OS: Overall survival
PFS: Progression-free survival
BSC: Best Supportive Care
DCR: Disease Control Rate
HR: Hazard Ratio
RAS: Rat Sarcoma
GHS: Global Health Status
MID: Minimally Important Difference
QLQ-C30: Quality of Life Questionnaire-Core30
EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire
TTD: time to deterioration
QoL: Quality of Life
ECOG PS: Eastern Cooperative Oncology Group Performance Status
EGFR: Epidermal Growth Factor Receptor
VEGF: Vascular Endothelial Growth Factor
BRAF: V-Raf Murine Sarcoma Viral Oncogene Homolog B1
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