Roche's Innovative Fixed-Dose Subcutaneous Dual-Target Therapy Phesgo® Approved in China for HER2-Positive Breast Cancer
Roche
Oncology Drug Research, Development, and Manufacturing
"Tuo Tuo" Dual-Agent Combination, 5-8 Minute Subcutaneous Injection, Completely Revolutionizes Breast Cancer Diagnosis and Treatment Model
ShanghaiJanuary 2, 2024 /PR Newswire/ --On January 2, 2024, the National Medical Products Administration (NMPA) of China officially announced the approval of Roche's Herceptin.®(General Name: Pertuzumab and Trastuzumab Injection (Subcutaneous Injection)), used for treating adult patients with HER2-positive early and metastatic breast cancer. The all-new Helijie Kang.®As the world's first compound subcutaneous formulation, it breaks through the technical bottleneck of drug delivery for tumor monoclonal antibodies. The "Pertuzumab and Trastuzumab dual-agent combination" can complete treatment in just 5-8 minutes, completely revolutionizing the traditional model of targeted breast cancer therapy. It provides a more convenient, efficient, and safer treatment option for breast cancer patients in China.
"Perfectly 'Cure' Her": Dual-Target Approach Paves New Path from "Treatment" to "Cure" in Breast Cancer
According to the latest data from the World Health Organization, breast cancer has replaced lung cancer as the world's leading cancer. In 2020, the number of new cases of breast cancer among Chinese women exceeded 416,000.[1]The incidence rate is 39.1 per 100,000, with approximately 117,000 deaths from breast cancer annually.[2]HER2-positive breast cancer accounts for about 20%-30% of all breast cancer cases, with high malignancy, high recurrence and metastasis rates, and a propensity for lymph node metastasis, leading to a poor prognosis. It has been referred to as "the most aggressive breast cancer."
20 years ago, the innovative targeted drug Herceptin®(Trastuzumab for Injection) has changed the outcomes for patients with HER2-positive breast cancer. After 1 year of standard adjuvant treatment with trastuzumab, approximately 75% of patients achieve 10-year disease-free survival.[3-6], which has completely changed the outcomes for patients with HER2-positive breast cancer. Subsequently, a series of studies confirmed that Perjeta®(Pertuzumab Injection) combined with Herceptin for neoadjuvant treatment, adjuvant treatment, and even the treatment of advanced breast cancer in HER2-positive patients can further reduce the risk of recurrence and prolong patients' lives.[7-10]The synergistic and complementary mechanism of action of Pertuzumab and Trastuzumab can inhibit tumor growth more effectively, bringing long-term benefits to HER2-positive breast cancer patients from early to late stages. To date, more than 75 countries worldwide have approved Perjeta in combination with Herceptin for neoadjuvant, adjuvant, and first-line treatment of advanced HER2-positive breast cancer.
China also approved Perjeta in combination with Herceptin for the treatment of HER2-positive breast cancer in 2019. Currently, the 5-year survival rate for early-stage HER2-positive breast cancer patients in China exceeds 90%.[11], has taken the lead in stepping into the era of clinical cure among other tumors.
"Surely" Advancing, Innovating with Patients at the Core: "Healing" Her in One Step
Compared with Western countries, the onset age of breast cancer in China is earlier, with the peak incidence occurring between 45-55 years old, whereas in Western countries, it mostly occurs after the age of 65.[12]Breast cancer has an even greater impact on the normal work and life of Chinese patients, and their demand for recovering from the illness and reintegrating into society is also stronger. Therefore, in the "post-cure" era, how to further meet the higher needs of breast cancer patients and enable them to return to life and reintegrate into society with more dignity has become more urgent.
Subcutaneous formulations for tumors break the limitations of existing intravenous treatments, significantly reducing the time patients and their families spend in the hospital through a fast and convenient drug delivery method; the treatment time that originally required several hours of hospitalization has been drastically reduced to 5 to 8 minutes, rapidly promoting the shift of targeted tumor therapy to outpatient, community, and home settings. In addition, the subcutaneous drug delivery method is minimally invasive, enhancing patient comfort while eliminating risks such as venous thrombosis. It also helps patients and their families save on costs related to hospitalization, establishing intravenous access, and caregiving, significantly conserving medical resources and social costs, and to the greatest extent possible, allows cancer treatment to not interrupt the patient’s normal work and life.
Hercuton®As the world's first fixed-dose combination subcutaneous formulation, it completely revolutionizes the diagnosis and treatment model for breast cancer. Unlike traditional intravenous therapy, Helijiekang.®It is a ready-to-use, fixed-dose combination of trastuzumab and pertuzumab administered via subcutaneous injection in the thigh. Utilizing innovative drug delivery technology, it concentrates the dual monoclonal antibodies into a fixed dose. The "two-in-one" administration process is simple, requiring only 5-8 minutes to complete treatment. Recombinant human hyaluronidase (rHuPH20) temporarily reduces interstitial viscosity, promoting rapid drug diffusion and absorption. After injection, the original subcutaneous structure quickly recovers, minimizing swelling and ensuring patients experience no significant pain. Its flexible, convenient, and one-step treatment experience brings Chinese breast cancer patients closer to the goal of physical and mental recovery.
In addition, to comply with Healthy China2030“Centered on People's Health”Core Concept and the Requirements for Chronic Disease Management of Tumors, Roche Classic Anti-HER2Product: Herceptin®SC(General Name: Trastuzumab Injection (Subcutaneous Injection)) was approved just one year ago and2023Year12Month13Successfully included in the national medical insurance catalog, allowing breast cancer patients in China to be the first to benefit from innovative drugs and upgraded diagnostic and treatment plans, demonstrating the attention of the Chinese government to breast cancer patients and its strategic decisions to deepen the medical security system.
"New 'Tuo Tuo' surpasses classic efficacy, bringing multiple benefits to healthcare professionals and patients"
This time Roche®The approval was mainly based on the FeDeriCa clinical study. The FeDeriCa study is a global Phase III randomized, open-label, and international multi-center non-inferiority clinical trial, which randomly assigned HER2-positive breast cancer patients in a 1:1 ratio to receive either intravenous treatment with trastuzumab and pertuzumab or subcutaneous administration of trastuzumab and pertuzumab, in order to compare the differences in pharmacokinetics, efficacy, and safety between the two treatments. The study results showed that...®There is no significant difference between the two treatments in terms of serum drug concentration, pathological complete response rate, and incidence of adverse reactions.
At the same time, the PHranceSCa study, which explored patient preferences for dual-target intravenous and subcutaneous injections, showed that 85% of HER2-positive breast cancer patients receiving dual-target treatment preferred Herceptin.®; After Cycle 6, 136/160 patients (85%) reported a preference for subcutaneous administration of Herceptin, with the most common reason being the shorter time required for outpatient administration.[13]. At the same time, the PHranceSCa study once again confirms that Roche's®Consistent with the known benefits of the intravenous formulation of the dual-target drug, and no significant differences in safety compared to the intravenous formulation.[14]。
Dr. Li Xin, Head of Roche Global Pharma Development China Center, said: "Hercutin®"There is a significant improvement over the traditional intravenous injection in terms of drug delivery, which not only reduces treatment costs and saves time but also greatly enhances patient compliance. Patient experience and the consumption of corresponding medical resources have also improved significantly compared to previous intravenous drug administration. The approval of He Jiekang this time brings closer the realization of the dream for breast cancer patients to 'spend the least time being a patient and more time being themselves.'"
Roche Pharmaceuticals China President Bian Xin said: "The entry of tumor treatment into the subcutaneous era is a global trend and frontier, which means that the treatment model for cancer patients may shift towards chronic disease management. Embodying“Acting on Patients' Needs First”The concept, Roche Pharmaceuticals China will continue to actively cooperate with all parties, focusing on exploring‘Patient-Centered’A new ecosystem for tumor diagnosis and treatment, helping more breast cancer and other tumor patients to maximize their freedom from the constraints of disease treatment and return to a happy and beautiful life.”
[1]Global Cancer Burden in 2020, IARC
[2] https://www.iarc.fr/faq/latest-global-cancer-data-2020-qa/All data in the article are from: International Agency for Research on Cancer, World Health Organization
[3] PEREZ EA，,et al. Trastuzumab plus adjuvant chemotherapy for human epidermal growth factor receptor 2-positive breast cancer: planned joint analysis of overall survival from NSABPB-31 and NCCTGN9831[J]． J clin oncol 2014, 32(20):3744-3752．
[4] De Azambuja E, et al. Trastuzumab—associ ated cardiac events at 8 years of median follow-up in the HERceptin Adjuvant trial(BIG1-01)[J]. J clin oncol, 2014,32(20):2159-2165．
[5] Romond EH, et al. Seven year follow-up assessment of cardiac functionin NSABPB-31. a randomized trial comparing doxombicin and cyclo-phosphamide followed by paclitaxel (ACP) with ACP plus trastuzumab as adjuvant therapy for patients with nodepositive, human epidermal growth factor recept or 2-positive breast cancer[J]. J clin oncol 2012(30):3792-3799．
[6] Camerond D,et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2- positive early breast cancer:final analysis of the Herceptin Adjuvant (HERA) trial [J]. The Lancet,2017,389( 10075):1195．
[7] Camerond D,et al. 11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2- positive early breast cancer:final analysis of the Herceptin Adjuvant (HERA) trial [J]. The Lancet,2017,389( 10075):1195．
[8] Eight-year data from APHINITY study show Roche’s Perjeta-based regimen continues to reduce the risk of disease returning for people with HER2-positive early breast cancer. https://www.roche.com/media/releases/med-cor-2022-07-14b
[9] Gianni l, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort[J]. Lancet.2010 Jan 30;375(9712):377-84.
[10] Gianni L, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol.2016 Jun;17(6):791-800.
[11] https://shmc.fudan.edu.cn/news/2022/0221/c1893a130223/page.htm
[12] https://mp.weixin.qq.com/s/CvvdSgBMH1W-hpEdHi0lSQ
[13] Jackisch C et al, Adv Ther. 2022 Feb;39(2):833-844.
[14] O‘Shaughnessy J，et al. 2023 ESMO BC Abstract 97P