On July 9th, 2022 Roche Oncology Summit was successfully held online. Many academic experts in the field of oncology at home and abroad gathered in the cloud to discuss hot issues related to tumor diagnosis and treatment, share the latest research progress, and exchange clinical diagnosis and treatment experience. In the first chapter of the breast cancer special session “Walking with HER”, Jiangsu Provincial People’s HospitalProfessor Yin Yongmeiand new strong>Professor Lee Soo Chin, National University of Singapore Cancer Center shared the opportunities and challenges in the treatment of HER2-positive breast cancer and the dual-target subcutaneous preparation of Tripam A wonderful report leading the new transformation of the targeted therapy model.
HER2-positive breast cancer: opportunities and challenges
In recent years, many breakthroughs have been made in the treatment of HER2-positive breast cancer, but the exploration of anti-HER2 therapy is far from over. Professor Yin Yongmei said that HER2-positive breast cancer is very aggressive and has a very poor prognosis.qu The advent of tocilizumab has transformed the entire treatment of HER2-positive breast cancer. Multiple studies have confirmed that trastuzumab significantly improves the prognosis of patients with HER2-positive breast cancer regardless of early neoadjuvant/adjuvant therapy or advanced therapy. Thenthe emergence of Pertuzumab opened the era of dual-target therapy for HER2-positive breast cancer. Numerous studies such as NeoSphere, APHINITY and CLEOPATRA have shown that from neoadjuvant and adjuvant therapy to advanced first-line treatment of HER2-positive breast cancer, the double-targeted trippa regimen can further improve the curative effect and prolong the survival of patients. Based on these findings, dual-targeting of tripa is the standard of care for HER2-positive breast cancer.
Recently, the results of the 8.4-year follow-up of the APHINITY study were published . The results showed that compared with single-target therapy, tripa-dual-target adjuvant therapy maintained the benefit, the 8-year invasive disease-free survival (iDFS) rate was 88.4%, and the ITT population had no invasive disease. The risk of disease recurrence was reduced by 23%. Among them, lymph node-positive patients benefited more significantly, and the 8-year iDFS rate of the tripa dual-target group was improved by 4.9% (86.1% vs 81.2%, HR 0.72) compared with the single-target group, and regardless of hormone receptor status, it can be improved from Long-term benefit of dual-target adjuvant therapy with tripa. Although the OS data of 8-year follow-up are not yet mature, the number of deaths in the dual-target treatment group is less than that in the single-target group, and there is a trend of continuous improvement in OS after the addition of pertuzumab. These data reconfirm the long-term benefit of dual-target adjuvant therapy with trippa. In addition,the 3-year event-free survival (EFS) data from the pivotal Phase III PEONY study of the first Asian-based dual-target neoadjuvant therapy with trippa will be announced at this year’s SABCS Congress< /span>. It is believed that with the gradual maturity of the long-term follow-up data of APHINITY and the release of the 3-year survival data of the PEONY study, it will further consolidate the cornerstone position of double-targeted trippa from early neoadjuvant to postoperative adjuvant therapy. Figure 2 ITT population and lymph node positive population reported in three APHINITY study
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In addition, the final analysis results of the CLEOPATRA China bridging study PUFFIN study were also released at this year’s ESMO BC conference. The results showed that with the median follow-up time The median progression-free survival (PFS) in the dual-target therapy group was prolonged from 12.5 months to 16.5 months in the single-target therapy group, and the HR value of PFS decreased to 0.60< /span>(95%Cl, 0.45-0.81),reduced the risk of progression or death by 40%. Median OS was not reached in either group with HR of 0.68. In terms of safety, it was consistent with the known safety profile of Pertuzumab. Overall, the PUFFIN study demonstrated the dual target of tripa The safety and survival benefits of the treatment of Chinese patients with HER2-positive advanced breast cancer are highly consistent with the global CLEOPATRA study, which further provides new and powerful evidence-based medical evidence for Chinese patients to use the tripa-targeted regimen with greater confidence.
FINS and the results of the PUF study in Figure 3
Professor Yin Yongmei pointed out that the double target of Tripamide can improve the majority of HER2-positive breast cancer The prognosis of cancer patients can reduce the risk of recurrence, but eventually some patients will develop recurrence and metastasis. For this group of patients, enmetezumab (T-DM1) provides an effective treatment option for neoadjuvant therapy Adjuvant therapy for patients with residual disease (non-pCR) and second-line therapy for advanced patients. It can be seen that In the past 20 years, Roche has continuously faced challenges and seized opportunities, and gradually established a full-course anti-HER2 treatment system from (neo)adjuvant to advanced stage, escorting HER2-positive breast cancer standardized treatment to prolong the life of patients with HER2-positive breast cancer.
However, HER2-positive breast cancer is not a single disease, and has strong heterogeneity and complexity, which means that there are still clinical uncertainties. needs being met. Professor Yin Yongmei said that HER2-positive breast cancer future exploration directions include drug safety and quality of life balance, optimal treatment sequence of advanced anti-HER2 drugs, exploration of anti-HER2 resistance mechanism and optimization of follow-up treatment, identification of patients with brain metastases and improvement of prognosis, sub-population and combination drug strategies, etc.. Especially with the rapid development of anti-HER2 therapy, maximizing the quality of life has become an important treatment goal in addition to prolonging the survival of cancer patients. In this regard, tripa dual-target fixed-dose combination subcutaneous formulation (PH FDC SC)with its flexible and convenient administration and equally excellent Efficacy and safety are preferred by most patients, hope this new dosage form will benefit Chinese patients in the near future. In addition to optimizing the way of administration, related researches on anti-HER2 targeted drugs combined with PD-1/PD-L1 inhibitors, endocrine therapy drugs, CDK4/6 inhibitors, PAM pathway inhibitors, etc. (such as Astefania, APTneo, KATE3, hereedERA , monarchHER, PATINA, INAVO122, EPIK-B2 studies) are also in progress, in the future, further subdivision of HER2-positive breast cancer patients, and providing more precise individualized treatment may achieve longer survival for patients and ultimately achieve the goal of tumor cure .
Tripa dual-target subcutaneous preparation leads a new paradigm of targeted therapy for HER2-positive breast cancer< /p>
There is no doubt about the role and status of double-targeted tripa in the treatment of HER2-positive breast cancer, but there is still room for further optimization of the treatment plan. In this regard, Professor Lee Soo Chin presented a presentation entitled “Improving patient benefit: Tripam dual-targeted subcutaneous formulation leads the way in HER2-positive breast cancer A wonderful report on New Changes in Targeted Therapy Models. PH FDC SC is a 3-in-1 fixed-dose subcutaneous injection of the dual target of tripa and hyaluronidase. FeDeriCa studyhas confirmed that PH FDC SC has pharmacokinetics, efficacy and safety Consistent with the dual target intravenous infusion of tripa (P+H IV). In terms ofpatient preferences,The PHranceSCa study showed that 85% of all treated patients preferred PH FDC SC, and 88.1% of patients were more likely to choose PH FDC SC. Very satisfied or satisfied, 86.9% of patients chose the treatment after the subcutaneous injection was completed. Reduced outpatient time and comfort during administration are the main reasons why patients prefer subcutaneous formulations. Based on data from these two studies, PH FDC SC was approved by the U.S. FDA in June 2020 for the treatment of patients with metastatic or early-stage HER2-positive breast cancer. In addition, this year’s ESMO ASIA meeting will also announce the primary endpoint analysis data of FDChina, the efficacy trial of the dual-target subcutaneous preparation of tripa in the Chinese population.
Compared with dual-target intravenous infusion of tripa, the characteristics of the dual-target subcutaneous preparation of tripa include Fixed dose, short administration time (5-8 minutes) and short post-administration observation time (15-30 minutes), these characteristics are very important for patients, doctors and nurses People and even hospitals/healthcare systems have a big impact. For patients, does not require intravenous cannula, administration and observation time are shorter, Satisfaction increased. athealth care workers< /strong>In terms of, a fixed dose is not only easy to prepare, but also reduces the risk of dose calculation or administration errors, and reduces nursing and observation time , lightening their workload. In terms of hospital/health care system, reduced treatment and observation time for patients, releasing a large amount of medical treatment. resources, and reduce the number of people gathered in treatment centers to reduce the risk of virus infection, which is especially important under the normalization of epidemic prevention and control >.
double target Comparison of subcutaneous injection and intravenous infusion
Based on changes in the dual-targeted administration mode of tripa, Lee Soo Chin Professor also took the NCIS-on-the-Go business model as an example to share the advantages and feasibility of transferring cancer treatment from the hospital to the community in Singapore, and said that he would accept low-risk and complete cancer treatment in a short period of time. Patients (such as subcutaneous injections), moving from the hospital to the community can benefit all stakeholders in the healthcare ecosystem, creating a win-win situation.
The hotspots and future of HER2-positive breast cancer treatment are discussed by major experts
The collision of thinking among the big names in the field not only helps to improve the level of clinical diagnosis and treatment, but also helps to broaden the horizons and thinking. Under the auspices of Professor Wang Haibo from Qingdao University Affiliated Hospital, Professor Ge Rui from East China Hospital Affiliated to Fudan University , Prof. Li Nanlin from Xijing Hospital of Air Force Military Medical University, Prof. Hu Hong from Shenzhen People’s HospitalAdjuvant de-escalation therapy for HER2 early breast cancer (neo), future anti-HER2 combination therapy for HER2 positive advanced breast cancer Strategies, the advantages of dual-targeted tripa subcutaneous formulations, and hot topics such as how to maximize the value of dual-targeted subcutaneous formulations of tripa in China combined with Singapore’s flexible treatment experience are discussed in depth.
Professor Wang Haibo
In medical practice, advanced pharmaceutical preparation technology and advanced treatment concepts often complement each other. , Tripax dual target has become the standard treatment for HER2-positive breast cancer. Whether it is early neoadjuvant/adjuvant therapy or advanced treatment, Tripax dual target requires long-term application, so the emergence of Tripax dual target subcutaneous preparation not only makes clinical The treatment is more convenient, and more patients can benefit from this more convenient, safe and effective treatment. I hope that the double-target subcutaneous preparation of tripa can be launched in China as soon as possible, so that Chinese patients with HER2-positive breast cancer can benefit from it. Benefit. It is believed that after the dual-target subcutaneous preparation of Tripax is launched in China, the treatment of more and more HER2-positive breast cancer patients may be transferred from the hospital to the community, bringing a revolutionary change to the treatment mode of HER2-positive breast cancer.< /span>
Professor Ge Rui
About HER2 early breast cancer (new) adjuvant reduction Step-down therapy, in the past, the so-called step-down was more about chemotherapy than targeted therapy. Now with the deepening of research, the concept of step-down has been further extended. In the future, we look forward to further exploring the use of more biological Markers are used to screen (neo) assisted de-escalation populations, and de-escalation therapy can be performed on the premise of ensuring prognosis to improve patient compliance and quality of life. Regarding the application of tripa dual-target subcutaneous preparations in China, it can be said that it is possible in the future. Based on China’s national conditions, there are still many epidemic control factors in China. In terms of avoiding the interruption or shedding of patients’ treatment, the double-target subcutaneous preparation of Tripamide will play a great advantage. At present, major cities in China are promoting the extension to the community. We hope that the flexible treatment model of subcutaneous preparations in Singapore can be replicated in most of our cities. By then, breast cancer patients can enjoy high-quality services and guarantee treatment. therapeutic effect, while enjoying the convenience of medical treatment.
Professor Li Nanlin
on neoadjuvant therapy for HER2-positive breast cancer Exploration, the recent single-arm Brecan study carried out by our team has achieved phased results. Our study showed that dual-target anti-HER2 therapy was extended to 8 cycles, and pegylated liposomal doxorubicin (PLD) and nab-paclitaxel (Nab-P) were used instead of doxorubicin and paclitaxel (PldC+HP× 4→Nab-P+HP×4), the pCR rate of this neoadjuvant therapy regimen is as high as 80.2%, and the cardiac safety is good, showing great potential for synergism and detoxification. Regarding advanced treatment of HER2-positive breast cancer, there are differences in the lineup of patients who are sensitive and insensitive to anti-HER2 therapy. Moreover, the availability of drugs such as DS8201 and pyrotinib is different at home and abroad, resulting in slightly different deployments at home and abroad. How to make good use of the drugs at hand to make a reasonable arrangement, prolong the survival of patients and save costs, is a problem that Chinese doctors need to think about now.
Professor Hu Hong
About double-target subcutaneous preparation of Tropa Simplicity, care and short observation time are very important advantages. However, the administration and observation time of double-target intravenous infusion of tripa is very long, as well as problems such as intravenous cannulation and dispensing, which lead to the treatment of double-target intravenous infusion of tripa mainly in hospital or day ward, which requires time, space and cost. Costs and medical costs are high. If the double-target subcutaneous preparation of tripa is available in China in the future, the patient can make an order in the outpatient clinic, and then complete the injection in the injection room. This will greatly save the time of patients and medical staff and reduce the occupation of the entire medical resources. In addition, affected by the epidemic, many patients are inconvenient to go to the hospital for treatment. With the double-target subcutaneous preparation of tripa, we can provide continuous services outside the hospital, so that patients who are inconvenient to go to the hospital can receive timely treatment, thereby ensuring the curative effect.
Summary
With the continuous advent and wide application of anti-HER2-targeted drugs, the survival and prognosis of HER2-positive breast cancer patients have been significantly improved. From chemotherapy to single-target trastuzumab, to dual-targeting of trastuzumab, the treatment model for HER2-positive breast cancer is constantly innovating. The advent of ADC drugs and small-molecule TKIs has further enriched the treatment options for HER2-positive breast cancer. In the process of pursuing quality survival benefits, especially in the context of epidemic prevention and control, the improvement of the administration mode represented by the double-target subcutaneous preparation of tripa has significant advantages. It is expected that Chinese breast cancer patients can also use it soon. on this new formulation.
Edit: Max
Typesetting : Youshi
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