Targeted Therapy Reshapes the Treatment Landscape of HER2-Positive Breast Cancer: The Launch of Pertuzumab Biosimilar Adds a New Dimension
Qilu Pharmaceutical
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
HER2 (human epidermal growth factor receptor 2, epidermal growth factor receptor 2) positive breast cancer accounts for about 15%-20% of all breast cancer cases. This type of breast cancer is highly aggressive and has a poor prognosis. In recent years, the development of anti-HER2 targeted drugs has changed the treatment model for patients with HER2-positive breast cancer and improved overall prognosis, significantly increasing the cure rate for early-stage patients and extending the survival period for advanced patients. Recently, the pertuzumab biosimilar developed by Qilu Pharmaceutical Co., Ltd. has been approved for marketing in China. Against this backdrop, our newspaper was invited to...Professor Haibo Wang from the Affiliated Hospital of Qingdao UniversityIn-depth Analysis of the Importance of Targeted Therapy in HER2-positive Breast Cancer and the Impact of the Market Launch of Pertuzumab Biosimilars on HER2-positive Breast Cancer Treatment. The following is a summary of the interview highlights for readers.
Expert Resume
Professor Wang Haibo
Affiliated Hospital of Qingdao University
Breast Disease Hospital of Qingdao University Affiliated Hospital President
Clinical Translational Research Institute of Solid Tumors, Qingdao University President
Chinese Society of Clinical Oncology Breast Cancer Expert Committee Vice Chairman
Breast Cancer Professional Committee of China Anti-Cancer Association Standing Committee Member
Chinese Breast Specialist Training Expert Committee of Chinese Medical Doctor Association Standing Committee Member
Chinese Medical Doctor AssociationMicroNon-Invasive Committee Breast Branch Vice Chairman
Breast Disease Branch of China Pharmaceutical Education Association Standing Committee Member
Chinese Association for Promoting Breast Plastic Surgery Standing Committee Member
Shandong Provincial Association of Rehabilitation Medicine - Breast Disease Branch Chairman
Shandong Provincial Clinical Oncology Association Breast Branch Director-elect
Shandong Medical Association Breast Multidisciplinary Collaboration Branch Vice Chairman
Q1：HER2-positive breast cancer is a subtype of breast cancer with strong invasiveness, high malignancy, and rapid progression. Its treatment strategy has undergone a breakthrough transformation due to the emergence of targeted therapy. How do you evaluate the status of targeted therapy in the current treatment strategy for HER2-positive breast cancer?
Professor Wang Haibo:Targeted therapy is not only the core approach in the treatment strategy for HER2-positive breast cancer but also the key driving force propelling continuous advancements in this field.
For the treatment of early breast cancer, targeted therapy represents a revolutionary breakthrough. In adjuvant therapy, the HERA trial, for instance, clearly demonstrated the significant efficacy of trastuzumab. It can reduce the risk of disease-free survival by 24% and lower the risk of death by 26% in women with HER2-positive status. This means that for patients with HER2-positive early breast cancer, receiving one year of adjuvant trastuzumab treatment after chemotherapy can significantly prolong their progression-free survival. The trial established trastuzumab as a standard treatment option for HER2-positive early breast cancer patients to some extent. The APHINITY trial highlighted the significant advantage of the dual-target regimen combining trastuzumab and pertuzumab in reducing recurrence risk among high-risk patients, emphasizing the importance of dual-target therapy in treating HER2-positive breast cancer. Regarding neoadjuvant therapy,NeoSphereThe trial also showed that docetaxel combined with pertuzumab and trastuzumab dual-targeted therapy can extend patients' survival benefits. This finding has driven the shift in treatment strategies from postoperative adjuvant to neoadjuvant.The Transition。
In the treatment of advanced breast cancer, targeted therapy has significantly extended the survival of patients with HER2-positive breast cancer. Currently, the NCCN guidelines recommend the combination of pertuzumab, trastuzumab, and docetaxel as the first-line treatment for HER2-positive metastatic breast cancer. The results of the CLEOPATRA trial established this regimen.QuPaDoubleTargetIn the standard position for first-line treatment of advanced HER2-positive breast cancer. In second-line treatment, the pivotal EMILIA trial of T-DM1 also demonstrated clinical benefits in progression-free survival (PFS) and overall survival (OS), significantly reducing the risk of death for patients.
Not only that, but targeted therapy has also driven the shift in treatment philosophy towards a holistic management approach. From traditional chemotherapy to targeted therapy, then to dual-target therapy, ADC drugs, and genetic testing technologies, this series of developments has gradually deepened the personalized treatment and precision medicine concepts for HER2-positive breast cancer.
Q2: In recent years, the continuous development of biosimilars in the field of targeted therapy has brought significant positive impacts to the treatment of HER2-positive breast cancer. Compared with originator drugs, what are the key points that need special attention during the research and development and clinical application of biosimilars?
Professor Wang Haibo:Key Points to Focus on During the Research, Development, and Clinical Application of Biosimilars
First, before medication, we need to routinely assess the patient's medical history, previous treatment history, adverse reaction history, and baseline medication status, and complete relevant laboratory tests, imaging examinations, organ function tests, and evaluations of comorbidities.
Second, patient education and communication are also crucial. We need to comprehensively consider the demographic characteristics of patients and their level of understanding of biosimilars, providing them with thorough explanations regarding the concept, efficacy, safety, and cost-effectiveness of the drugs. Additionally, medication education should be conducted to ensure patients understand the drug name, purpose of use, storage methods, dosage, frequency, as well as common knowledge about adverse reactions and how to manage them.
Third, when clinical treatment does not achieve the expected results, we need to refer to the reference drug for adjustments to the biosimilar medication regimen, including individualized dose adjustments or switching to other drugs.
Fourth, and very importantly, we need multidisciplinary team management, including physicians, pharmacists, and nurses to form a multidisciplinary treatment team to manage the entire process of biosimilar clinical application. A medication plan should be formulated before treatment, with strengthened prescription review to ensure drug information is traceable. During treatment, effectiveness and safety should be monitored and evaluated, with early identification and management of adverse reactions. After treatment, patients should receive regular follow-ups and be provided with medication counseling and other home-based medical services.
Q3: On December 23, 2024, the official website of the National Medical Products Administration (NMPA) formally announced that the HER2-targeted pertuzumab biosimilar developed by Qilu Pharmaceutical Co., Ltd. has been approved for marketing. What impact do you think the launch of this new drug will have on the current treatment of HER2-positive breast cancer and future research and development?
Professor Wang Haibo:Qilu Pharmaceutical's Pertuzumab Biosimilar Successfully Launched, Offering More Options for HER2-Positive Breast Cancer Treatment and Positively Influencing Future Drug Development
For a long time, the originalResearchPertuzumab has not been included in the medical insurance reimbursement scope in the field of advanced HER2-positive breast cancer treatment.QuPaSubcutaneous injections are currently reimbursed by medical insurance only for newly diagnosed HER2-positive breast cancer patients with advanced disease. For those metastatic breast cancer patients who have already undergone systemic treatment, reimbursement is still not available. This places a heavy financial burden on many advanced-stage patients, making it difficult for them to afford the cost of standardized treatment.
In order to break this dilemma, Qilu Pharmaceutical, at the launch of Pertuzumab Injection, adhering to the spirit of humanistic care, has specially introduced a charitable assistance policy covering from early to late stages. Even for the original...ResearchPatients with advanced metastatic breast cancer who cannot be reimbursed also have the opportunity to reduce financial pressure and obtainUrgently NeededTherapeutic Support.
This initiative has not only significantly improved the accessibility of the drug but also given more HER2 breast cancer patients hope to continue their treatment. By alleviating the financial burden on patients and their families, they can focus more on the treatment itself and fight against the disease. This drug donation policy not only shows deep concern for the quality of life of patients but also actively assumes social responsibility, bringing tangible help and hope to patients with advanced HER2-positive breast cancer.
At the same time, the market entry of pertuzumab biosimilars will stimulate enthusiasm among pharmaceutical companies in China for the development of biosimilars, promoting the flourishing growth of the biosimilar market. During the R&D process, pharmaceutical companies in China have accumulated extensive experience and technology, which helps enhance China's R&D capabilities in the field of biosimilars and even the entire biopharmaceutical sector. This will accelerate the internationalization of China’s pharmaceutical companies, driving more high-quality and efficient biosimilars to enter the international market. Meanwhile, new...MedicineThe successful development will also stimulate pharmaceutical companies' enthusiasm for innovative drug research and development, promote the continuous emergence of new targets and new mechanism drugs for HER2-positive breast cancer, and bring more breakthroughs and hope to breast cancer treatment.
Q4: The marketing of pertuzumab biosimilars marks another significant advancement in the field of breast cancer treatment in China. Looking ahead, how should Chinese researchers and enterprises further strive to continuously play a leading and driving role in this field?
Professor Wang Haibo:Looking ahead, we need to strengthen the integration of basic and clinical research. We should promote close collaboration between clinicians and basic researchers to gain a deeper understanding of breast cancer pathogenesis through translational medical research and develop more new treatment strategies. At the same time, we must encourage original research, particularly in molecular subtyping and new drug development, to enhance China's standing in the international field of breast cancer research. Moreover, we need to advance the development of precision medicine. By utilizing advanced technologies such as ctDNA and genetic testing, we can implement precision treatment, selecting the most suitable treatment plans for patients to improve treatment outcomes and survival rates. Additionally, we should develop new biomarkers to better predict patients' responses to treatment and optimize therapeutic strategies. Finally, it is essential to enhance international cooperation and exchange, actively participate in large-scale international clinical trials, and push Chinese breast cancer research to the global forefront. Strengthening collaborations with top international research institutions and pharmaceutical companies will help introduce advanced technologies and management expertise, accelerating the development and market entry of new drugs, ultimately bringing more benefits to breast cancer patients worldwide.
From adjuvant therapy to neoadjuvant therapy for early HER2-positive breast cancer, and even first-line treatment for advanced stages, targeted therapy has always played a pivotal role. In recent years, the continuous development and market entry of biosimilars have significantly advanced treatment strategies for HER2-positive breast cancer. Notably, the launch of pertuzumab biosimilars has injected robust new vitality into this field. Looking ahead, it is hoped that researchers in China will continue to make strides, further leading and driving innovation in breast cancer treatment, contributing more Chinese wisdom and strength to patients worldwide.