echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Digestive System Information > [2021 CSCO] Professor Li Jin: The only biosimilar of bevacizumab in China with clinical data on metastatic colorectal cancer, HLX04 will become a new choice for anti-angiogenesis treatment

    [2021 CSCO] Professor Li Jin: The only biosimilar of bevacizumab in China with clinical data on metastatic colorectal cancer, HLX04 will become a new choice for anti-angiogenesis treatment

    • Last Update: 2021-10-11
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    *It is only for medical professionals to read for reference.
    Anti-angiogenesis therapy is now about to usher in a new choice of high quality and high price! Angiogenesis plays an important role in tumorigenesis and development.
    With the entire process of tumorigenesis and development, anti-angiogenesis has become an important means to inhibit tumorigenesis and development.
    Vascular endothelial growth factor (VEGF) or epidermal growth factor receptors are used as targets.
    New biological therapies have improved clinical results.
    The original bevacizumab, as a representative, brings hope to patients with colorectal cancer, lung cancer, glioma, and liver cancer.
    At the same time, the high cost of treatment has discouraged many patients
    .

    Fuhong Henlius adheres to the belief of bringing high-quality and high-cost treatment options to the majority of Chinese patients.
    The bevacizumab biosimilar HLX04 developed with great concentration has selected metastatic colorectal cancer (mCRC) in the design of the phase III clinical study.
    Indications, and reached the primary and secondary research endpoints of the study, becoming the only biosimilar of bevacizumab with clinical data of mCRC in China
    .

    In this regard, we specially invited Professor Li Jin from Tongji University Dongfang Hospital to explain to us the past, present and future of HLX04 treatment of mCRC
    .

    Professor Li Jin’s interview video looks back on the past: anti-angiogenesis therapy should benefit more patients.
    Colorectal cancer (CRC) accounts for about 10% of the global cancer-related death rate, and is the third largest cancer in the world
    .

    In recent years, with the rapid development of China's economy, people's living standards have improved significantly, their living habits have undergone tremendous changes, and the incidence of bowel cancer has also increased year by year
    .

    In 2020, the International Agency for Research on Cancer (IARC) of the World Health Organization released the latest global cancer burden data.
    China has 560,000 new CRC cases and 290,000 deaths.
    Bowel cancer has become the second most common cancer and the fifth most related cancer.
    Cause of death [1]
    .

    At the same time, about 20% of CRC patients have metastases (mCRC) at the initial diagnosis, and the 5-year survival rate of mCRC is only 10% [2]
    .

    Although bevacizumab has experienced several rounds of price reductions, the price has been lower than when it first entered the Chinese market, and it has also entered medical insurance
    .

    However, as a developing country, China still has a large number of low-income and poor patients who are not covered by medical insurance and cannot afford this treatment cost
    .

    Such patients urgently need a lower-priced drug with the same efficacy as bevacizumab
    .

    Professor Li Jin believes: “The world is advancing, science is constantly evolving, and medicines need to be constantly updated
    .

    If biosimilars with consistent efficacy and relatively low prices can be used to replace expensive original drugs, it can bring good news to ordinary people
    .

    At the same time .
    It can also help the country’s economic construction and use more funds to develop new products in order to help China develop more innovative pharmaceuticals
    .

    This is also the original intention of our decision to apply HLX04 to the treatment of mCRC patients
    .

    "HLX04 Can the treatment of mCRC achieve the same efficacy as bevacizumab? The domestic phase III clinical study gave the answer
    .

    Focus on now: HLX04 has similar efficacy and safety to bevacizumab in the treatment of mCRC.
    The HLX04-mCRC03 study is a randomized, double-blind, controlled, multi-center phase III study, from April 13, 2018 to April 2020.
    It was launched in 63 centers in China on the 15th
    .

    677 patients were randomized 1:1 to receive HLX04 (n=340) or bevacizumab (n=337) treatment (7.
    5mg/kg, q3w combined with XELOX; 5mg/kg, q2w combined with mFOLFOX6)
    .

    The primary study endpoint is PFSR36w (PFS at 36 weeks) assessed based on the RECIST v1.
    1 standard; secondary study endpoints include the best objective response rate (BORR), 6, 12, 18, 24, 30, 36, 42, Objective response rate (ORR) at 48 months, overall survival rate (OSR) at 12 months, progression-free survival (PFS), time to onset (TTR), and duration of remission (DOR)
    .

    In August 2020, the Phase III study reached the primary and secondary research endpoints.
    It was the first oral presentation at the CSCO annual meeting that year and won the Outstanding Paper Award
    .

    In May 2021, the results of the Phase III study were officially published in BioDrugs
    .

    HLX04 vs.
    bevacizumab, the primary endpoint PFSR36w is equivalent to the HLX04 group vs.
    bevacizumab group PFSR36w was 46.
    4% (95%CI41.
    1–51.
    8) vs.
    50.
    7% (95%CI 45.
    4) –56.
    1), the rate difference between the two groups is -4.
    2% (90%CI −10.
    6-2.
    1), and the rate ratio is 0.
    92 (90%CI 0.
    80–1.
    05), both of which fall within the preset equivalent limit range ( Figure 1)
    .

    Figure 1.
    CIR-assessed PFSR36w (full analysis set) HLX04 vs.
    bevacizumab, with no significant difference in secondary endpoints BORR at week 48 and 6, 12, 18, 24, 30, 36, 42 in the HLX04 group Compared with the bevacizumab group, there was no significant difference in ORR at 48 weeks (Table 1)
    .

    Table 1.
    Summary of objective response rates assessed by CIR (full analysis set) 12-month OSR (HR 0.
    92; 95%CI 0.
    66–1.
    29; P=0.
    62) between HLX04 group and bevacizumab group (Figure 2a), PFS (HR 1.
    07; 95%CI 0.
    83–1.
    37; P=0.
    62) (Figure 2b), TTR (HR 1.
    11; 95%CI 0.
    91–1.
    34; P=0.
    30) (Figure 2c) or DOR (HR 1.
    14; 95%CI 0.
    80 –1.
    61; P=0.
    48) (Figure 2d), there was no significant difference (Figure 2)
    .

    Figure 2.
    12-month overall survival rate (a), CIR-assessed PFS (b), TTR (c), DOR (d) HLX04 vs.
    Bevacizumab, similar in safety The safety of the two groups is similar, HLX04 In the group vs.
    bevacizumab group, 336 patients (99.
    1%) vs.
    334 (99.
    1%) patients experienced at least one treatment emergency adverse event (TEAE) (Table 2)
    .

    There were 222 (65.
    5%) vs.
    238 (70.
    6%) patients in the HLX04 group vs.
    bevacizumab group who reported Grade ≥3 TEAE
    .

    The most common TEAEs of grade ≥3 were decreased neutrophil count (20.
    6% vs 20.
    2%), decreased platelet count (10.
    3% vs 10.
    1%), and hypertension (7.
    4% vs 12.
    5%)
    .

    The immunogenicity between the two groups was similar, and the detection rates of ADAs and NAbs were similar
    .

    Table 2.
    Summary of treatment of emergency adverse events (safety data set) The publication of the results of the HLX04-mCRC03 study once again provides strong evidence for the similar efficacy and safety of HLX04 and the original bevacizumab, confirming that HLX04 can be used as a treatment for mCRC New choice
    .

    Looking to the future: With clinical value as the guide and patient benefits as the core, HLX04 is very promising in anti-angiogenesis therapy.
    Professor Li Jin emphasized that whether it is a generic, biosimilar or innovative drug, its development needs to be oriented by clinical value.
    With patient interests as the core, the following four points need to be met: 1) Higher efficacy; 2) Better safety; 3) Low price; 4) Convenient medication
    .

    At the same time, Professor Li Jin said, “The energy spent on research and development of biosimilar drugs is similar to that of innovative drugs, but biosimilar drugs can help improve patient affordability and reduce treatment costs
    .

    From this point of view, it should be The research and development of biosimilar drugs has given certain support
    .

    " "The current clinical data has confirmed that HLX04 is exactly the same as the original product in the Chinese population at least
    .
    In the
    future, I hope that HLX04 can be launched as soon as possible, so as to provide more choices for the majority of Chinese patients with colorectal cancer.
    It is to help low-income people in the western region and poor people in rural areas
    .

    Because a person has only one life, everyone is equal before life, and every life is precious
    .

    " Professor Li Jin said
    .

    Based on the HLX04-mCRC03 study, HLX04 has become the only biosimilar of bevacizumab with clinical data on metastatic colorectal cancer in China, which has accumulated more clinical evidence for the application of bevacizumab in the Chinese population of colorectal cancer patients And experience
    .

    At present, Henlius has submitted a marketing registration application (NDA) to the National Medical Products Administration (NMPA) for the treatment of HLX04 for patients with metastatic colorectal cancer, and has officially been accepted by the NMPA
    .

    We look forward to HLX04 benefiting more cancer patients as soon as possible, bringing high-quality and high-priced treatment options
    .

    Expert profile: Professor Li Jin, Director of the Department of Oncology, Tongji University Oriental Hospital, Chairman of the Asian Oncology Alliance (FACO) Chairman of the CSCO Foundation Chairman of the CSCO Foundation Chairman of the Chinese Society for the Promotion of Drugs and Drugs, Former Chairman of the Chinese Society of Clinical Oncology (CSCO) References: [ 1] Latest global cancerdata: Cancer burden rises to 19.
    3 million new cases and 10.
    0 million cancerdeaths in 2020.
    Retrieved Dec 16, 2020, from https:// data-cancer-burden-rises-to-19-3-million-new-cases-and-10-0-million-cancer-deaths-in-2020/[2].
    ShukuiQin, Jin Li, Yuxian Bai, et al .
    Efficacy, Safety,and Immunogenicity of HLX04 Versus Reference Bevacizumabin Combination with XELOX or mFOLFOX6 as First-Line Treatment for Metastatic Colorectal Cancer: Results of a Randomized, Double-Blind Phase III Study[J].
    BioDrugs.
    2021 Jul;35(4)445 -458.
    *This article is only used to provide scientific information to medical professionals, and does not represent the views of this platform.
    *The medical community strives for the accuracy and reliability of the published content when it is approved, but it is not about the timeliness of the published content and the referenced materials Make any promises and guarantees for the accuracy and completeness of (if any), and assume no responsibility for the outdated content and the possible inaccuracy or incompleteness of the cited information
    .

    Relevant parties are requested to check separately when adopting or using this as a basis for decision-making
    .

    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.