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*For medical professionals only
The global phase III study of FRESCO-2 reached the endpoint of the trial, and fruquintinib provides a new treatment for
patients with advanced CRC worldwide.
In 2018, the FRESCO national multicenter study [1] co-led by Professor Qin Shukui and Professor Li Jin was successful, and the relevant results data were published in the top international journal JAMA magazine, which caused a sensation around the world
.
Based on the FRESCO study, fruquintinib was approved by the China Medical Products Administration and became the standard drug
for the third-line treatment of advanced colorectal cancer (CRC) recommended by the guidelines of the Chinese Society of Clinical Oncology (CSCO).
On September 12 this year, the data of the FRESCO-2 international multi-center phase III clinical study [2] was announced at the 2022 annual meeting of the European Society of Medical Oncology (ESMO), and once again obtained a positive outcome, which once again aroused widespread attention
in domestic and foreign academic circles.
The FRESCO-2 study, as a strong supporting and important supplement to the FRESCO study, further solidified the survival benefit
of fruquintinib for patients with advanced CRC worldwide.
Taking this as an opportunity, the "medical community" specially invited Professor Qin Shukui to give us an in-depth interpretation of the important results of
FRESCO-2 research.
Figure 1 FRESCO-2 study published at ESMO 2022
From FRESCO to FRESCO-2, Chinese wisdom is attracting attention around the world
According to the 2020 global cancer burden data released by the World Health Organization's International Agency for Research on Cancer (IARC), CRC has become the third most morbidity and the second most mortalized malignant tumor in the world[3], seriously threatening the health of
global residents.
Regarding the treatment of CRC, Professor Qin Shukui said: "At present, with the change of people's lifestyle and eating habits, the morbidity and mortality of CRC in China are increasing
year by year.
Approximately 50 percent of patients may develop advanced or metastatic CRC during the course of CRC [4].
First- and second-line standard treatment for advanced or metastatic CRC is two- or three-agent chemotherapy based on fluorouracil, oxaliplatin, irinotecan, and raltitrexed, plus bevacizumab or cetuximab
.
However, many patients progress after receiving second-line standard therapy, and second-line therapies and drugs are still very limited, and there is still a huge and unmet clinical need
.
”
With the positive results of the FRESCO study, fruquintinib entered the clinic as a tyrosine kinase inhibitor (TKI) originally developed by Hutchison Pharmaceutical, and has been widely used
in China 。 Professor Qin Shukui mentioned: "The FRESCO study is a large-scale randomized, double-blind, placebo-controlled, multi-center large-scale phase III clinical study conducted in China, which fully confirms the efficacy and safety of fruquintinib in Chinese patients with third-line CRC.
The FRESCO-2 study is a follow-up international multicenter phase III clinical study, which verifies that fruquintinib can bring significant survival benefits
to a wider range of CRC populations worldwide.
”
Regarding the differences between the two studies, Professor Qin Shukui pointed out: "First of all, the two studies are different in the background, when the FRESCO study was launched, there were no standard third-line treatment drugs and regimens for advanced CRC in China, and regorafenib and TAS-102 had not yet been approved for marketing in China, so the FRESCO study included people
who failed standard second-line treatment.
On top of this, the FRESCO-2 study also included patients who failed regorafenib and/or TAS-102, which also reflected differences in the medical environment and medication in China and abroad
.
From another perspective, the screening criteria for the FRESCO-2 study were more stringent than those of the FRESCO study, but these patients still achieved good survival benefits, confirming the consistent or stable antitumor activity
of fruquintinib.
”
"Second, in terms of sample size, the FRESCO study enrolled a total of 416 patients, while the FRESCO-2 study enrolled even more, reaching 691 patients
.
For a successful clinical study or research project, it is extremely important that it be reproducible, and the success of the FRESCO-2 study undoubtedly confirms the rigor and scientific design of the FRESCO study, the quality of the study can withstand repeated verification, and the results are credible
.
”
Fig.
2 FRESCO-2 study design diagram: planned enrollment 687, actual enrollment 691
FRESCO-2 research in-depth interpretation, the classics are not afraid to be hammered and refined
The FRESCO-2 study met all the primary and secondary endpoints, and Prof.
Qin Shukui briefly explained the study data: "On the primary study endpoint, median overall survival (mOS), fruquintinib significantly improved by 2.
6 months compared with placebo, showing excellent efficacy of fruquintinib with a risk ratio (HR) of 0.
66, or a 34%
reduction in the risk of death 。 Professor Qin Shukui emphasized: "It can be clearly seen in the survival curve (Kaplan-Meier curve) that the two curves are very clearly separated at the beginning stage and remain in a state for a long time, indicating that fruquintinib can achieve significant and long-term survival benefits
for most patients in the treatment of advanced CRC.
" ”
Fig.
3 OS survival curve of the main endpoint of the FRESCO-2 study
For the secondary study endpoint, Prof.
Qin Shukui elaborated: "In the median progression-free survival (mPFS) indicator, fruquintinib improved by 1.
9 months compared with placebo [3.
7 months vs.
1.
8 months, HR = 0.
32 (95% CI, 0.
27-0.
39); p＜0.
001]
。 and fruquintinib confers PFS benefit
in patients in all subgroups.
Based on the benefits of fruquintinib group in OS, PFS, ORR, DCR and other aspects in the FRESCO-2 study, it is very close to the FRESCO research data, which fully reflects the consistent efficacy of fruquintinib in patients with CRC in different regions and ethnic groups around the world, and further consolidates the survival benefit and objective efficacy
of the drug for advanced CRC.
”
Table 1 Comparison table of main data from the FRESCO study and the FRESCO-2 study
Regarding the safety of fruquintinib, Professor Qin Shukui pointed out: "Drug treatment is like a war, only on the basis of effectively protecting 'oneself' can we better destroy the 'enemy'
.
" In the FRESCO-2 study, the difference ≥in the incidence of grade 3 adverse reactions between the fruquintinib and placebo groups was not significant
.
The most common adverse reactions of fruquintinib were hypertension, followed by fatigue, proteinuria and hand-foot syndrome, and overall adverse events were expected, manageable, reversible, similar to the adverse effects of other TKI drugs, and no new safety signals
were seen.
”
Figure 4 FRESCO-2 Research Safety Data Diagram
China's original research rides the wind and waves, and the national innovation continues to be brilliant
Speaking about China's innovative drugs going global, Professor Qin Shukui said: "In the past, most of the drugs developed by domestic pharmaceutical companies belonged to me too or fast follow, but now they are actively exploring and innovating and progressing
。 Hutchison Pharmaceutical's expansion from the original research and development of fruquintinib from domestic multi-center FRESCO research to international multi-center FRESCO-2 research is an excellent example of the development of innovative drugs by national pharmaceutical enterprises, which shows the transformation process of China's innovative biopharmaceutical enterprises from young to mature and from biotech to biopharma, and is also a strong evidence
that Chinese pharmaceutical companies are based in China and go to the world.
”
Secondly, Professor Qin Shukui said: "In 2015, the Party Central Committee and the State Council clearly proposed to build a 'healthy China' as a grand strategic goal of our country, and the party and government attach great importance to people's health and tumor prevention and treatment
.
In recent years, the continuous increase in support for biomedicine and the development of the health industry have enabled national pharmaceutical enterprises to continue to develop and grow, and then have the ability, vision and mind to explore the domestic and international biomedical markets
.
”
Regarding the results of the FRESCO-2 research, Professor Qin Shukui said: "There is a way that science knows no borders! The FRESCO-2 study was carried out
smoothly with the support and participation of foreign researchers during the implementation process.
The research results also confirm once again that fruquintinib can not only benefit the majority of CRC patients in China, but also provide a new treatment method
for advanced CRC patients around the world.
It is reported that Hutchison Pharmaceutical also uses fruquintinib layout in other solid tumor fields, and is conducting relevant research to benefit more tumor patients
.
”
Professor Qin Shukui finally looked forward: "At present, the work of clinical trials in China is in the ascendant, which deserves more attention and participation
.
The party and the state pay more and more attention to people's health, national pharmaceutical enterprises continue to grow and develop, the level of clinical researchers is further improved, I believe that in the future China's clinical trials will continue to improve, and the road of new drugs to the sea will be increasingly broadened
.
Chinese pharmaceutical companies and researchers will certainly make positive and important contributions
to the health of all mankind.
”
NP-AYT-22N67-Valid Until 2024 Oct
The purpose of this material is to promote the communication and exchange
of medical information.
This material is intended for academic reference by healthcare professionals only and is not directed at the general public and is not intended for advertising
.
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approved by the State Medical Products Administration.
Please do not distribute or forward
this material.
Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer:The FRESCO Randomized Clinical Trial.
JAMA.
2018 Jun 26; 319(24):2486-2496.
[2]Dasari NA,et al.
FRESCO-2:A global phase III multiregional clinical trial(MRCT)evaluating the efficacy and safety of fruquintinib in patients with refractory metastatic colorectal cancer.
ESMO Congress 2022,LBA25.
[3]Sung H,Ferlay J,Siegel RL,et al.
Global Cancer Statistics 2020:GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
CA Cancer J Clin.
2021 May; 71(3):209-249.
[4] SUN Liying, MAO Ye, HUANG Zhiqun, et al.
Research progress of fruquintinib in advanced colorectal cancer[J].
Cancer Prevention and Treatment Research,2021,48(12):1135-1142.
)
*This article is only for providing scientific information to medical professionals and does not represent the views of this platform
