on december 18 2021, csco - tumor immunotherapy summit & envafolimab china launch meeting, hosted by the chinese society of clinical oncology (csco) and beijing csco foundation, was held in nanjing and guangzhou.
academician yan sun from cancer institute and hospital of chinese academy of medical sciences, professor zhongzhen guan from sun yat-sen university cancer center, professor meilin liao from shanghai pulmonary hospital, academician jia fan from zhongshan hospital of fudan university, academician xuehao wang from jiangsu provincial people hospital and academician jinming yu from shandong cancer hospital delivered congratulatory speeches as special guests. professor shukui qin from nanjing jinling hospital, professor lin shen from peking university cancer hospital, professor jun ma from harbin institute of hematology and oncology, professor jin li from dongfang hospital affiliated to tongji university, professor jun ma from sun yat-sen university cancer center, and professor baosheng li from shandong cancer hospital were the conference chairmen.
at the meeting, top experts in the national oncology clinical community discussed the clinical value of immunotherapy, the efficacy and safety of envafolimab, etc. the conference was broadcasted live on the internet, attracting more than 800,000 clinicians and industry professionals across china.
envafolimab is the world’s only subcutaneously administered pd-l1 single-domain antibody approved, co-developed by alphamab oncology (9966.hk), 3dmed, and simcere (2096.hk). it has received marketing authorization from the chinese national medical products administration (nmpa) on november 24, 2021. since the commercial shipment in early december, more than 600 patients in china have been treated with envafolimab within 6 days. in order to make this innovative drug available to more patients as soon as possible, a patient assistance program in cooperation with a charity foundation was also announced at the meeting. the nature of sc injection make it possible to be administered in community hospitals or even at home, therefore reserving healthcare resources in china and promoting the implementation of hierarchical diagnosis and treatment policy.
subcutaneously administrated in 30 seconds, tumor immunotherapy can be administered at home in future
although immunotherapy has become the mainstream drug in anti-tumor clinical treatment, and many products have been marketed at home and abroad, there is still a significant unmet clinical need for patients and a thirst for clinically superior drugs. professor shukui qin from nanjing jinling hospital commented, “the launch of envafolimab brings a new superior immunotherapy product to chinese malignancy patients. it required only 30 seconds of subcutaneous administration, which is clinically convenient, with good compliance, tolerability, and lower costs. recently, the cde published guidelines on clinical value-oriented anti-tumor drug clinical research and development, pointing out that patient needs are the guide, and in addition to efficacy, safety and convenience should be paid attention to. in clinical trials, the comparator drugs should be the best choice, i.e., with the best efficacy, the best safety, or the best convenience. envafolimab has advantage in all the three categories, which is very encouraging."
professor shen lin from peking university cancer hospital presented the latest clinical research progress of envafolimab, “envafolimab is not only the world’s first subcutaneously administered pd-l1 product, but also the first immunotherapy drug with cross-tumor indication and the first domestic pd-l1 drug in china. in comparison with other imported pd-1 and pd-l1 antibody drugs, the orr, pfs, median os and 12-month os rate are comparable and it has unique advantage. so i think envafolimab's unique safety and efficacy will attract global attention."
professor zhongzhen guan from sun yat-sen university cancer center said, “envafolimab is a pd-l1 monoclonal antibody developed in china, allowing patients to receive effective immunotherapy more conveniently. just like subcutaneous insulin injections for patients with diabetes, it could be administered at home in future."
professor jun ma from sun yat-sen university cancer center said, “envafolimab is very convenient as subcutaneous injection, which greatly shortens the time of administration, and improves the compliance of patients with the drug and the quality of life. envafolimab provides a key step in our efforts to treat tumors as chronic diseases."
professor jun ma from the harbin institute of hematology and oncology said, "under the covid-19 pandemic, we do not do intravenous (treatment) for hematological oncology patients if we have better choice, and preferred patients to be treated at home, in order to prevent cross-infection of patients in the hospital. with subcutaneous administration, envafolimab provides a new option for treatment in the community clinics or even at home in future. as the first immunotherapy drug with cross-tumor indication in china, its application prospects will be very broad."
3 major adverse reactions zero reported in phase ii study, even 96-years-old patient is eligible
there are still many concerns about adverse reactions in current immunotherapy, such as immune-related adverse reactions caused by pd-(l)1 drugs. conventional intravenous infusions require repeated punctures, which can also lead to the risk of infusion reactions.
regarding the safety profile of the drug, professor shen lin commented, “envafolimab's unique subcutaneous injection formulation avoids the adverse reactions of intravenous injection, especially allergic reactions. we have also found in practice that it has unique safety advantages for some elderly people with comorbidities and poor cardiopulmonary function. doctors are concerned about immune-related pneumonitis, immune-related colitis, or immune-related nephritis, which were not reported in the pivotal phase ii clinical trial. there was even a 96-years-old patient enrolled in the study, so there is a lot of room for exploring envafolimab in combination with other candidates in the future for the treatment of elder patients."
professor baosheng li from shandong cancer hospital said, “we have made a preliminary exploration of envafolimab combined with radiotherapy. the efficacy and safety is good. the combination of radiotherapy and immunotherapy has a good theoretical and practical basis. local radiotherapy leads to the release of new antigens from the tumor to obtain better efficacy, and the safety could also be improved, creating a result of 1 1 greater than 2."
the first immunotherapy drug with cross-tumor indication in china, benefiting chinese patients
the approved indication for envafolimab is for adult patients with microsatellite instability-high (msi-h) or mismatch repair deficient (dmmr) advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options. it is the first immunotherapy drug approved with tumor-agnostic indication in china.
the commercialization strategy and patient assistance program for envafolimab were announced at the launch meeting. according to the information announced at the conference: the price for envafolimab 200mg/vial is rmb 5980, once a week for subcutaneous administration, 4 vials per course of treatment at a cost of rmb 23,920 per course of medication. in order to improve the accessibility of the drug, with the support of beijing health alliance charitable foundation, envafolimab patient assistance program will be launched soon. according to the “4 4, 8 pd” assistance program, patients who meet the requirements of the first round of assistance and follow-up assistance of the program will be treated at the total cost of rmb 71,760, which is lower than imported pd-l1 products.
professor jin li of dongfang hospital affiliated to tongji university commented, “envafolimab is a product jointly developed by three chinese companies. chinese companies have a better understanding of the needs of chinese patients and are developing products addressing the unmet clinical needs of chinese patients, which i believe will help chinese patients, and hopefully global patients as well."
envafolimab is a single domain fc fusion pd-l1 antibody independently invented by alphamab oncology，and co-developed with 3d (beijing) medicines since 2016. on march 30, 2020, alphamab oncology, 3dmed, and simcere reached a strategic cooperation, whereby alphamab oncology is responsible for production and quality control, and 3dmed is responsible for the clinical development in oncology field, and simcere is responsible for the exclusive commercial promotion of products in mainland china.
based on its unique design that allows rapid subcutaneous injection, it has advantages of improved safety, convenience in drug administration, and treatment compliance. patients do not require an intravenous infusion which lowers medical costs. at present, envafolimab is being studied in clinical trials in multiple tumor types in china, the united states and japan, including registration/phase iii clinical trials in multiple indications. envafolimab obtained orphan drug designation from the us fda for the treatment of advanced biliary tract cancer and soft tissue sarcoma. in november 2021, envafolimab obtained the market approval by the chinese national medical products administration for the treatment of msi-h or dmmr advanced solid tumors, including those patients with advanced colorectal cancer who have experienced disease progression following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens as well as patients with other advanced solid tumors who have experienced disease progression following prior treatment and have no satisfactory alternative treatment options.
about alphamab oncology
alphamab oncology is focusing on innovation, production and commercialization of anti-tumor drugs. on december 12, 2019, the company was listed in the mainboard of hong kong stock exchange with stock code 9966.
alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a covid-19 bispecific antibody. four products have advanced into phase i-iii clinical trials or pre-marketing stage in china, the united states, japan and australia. in november 2021, envafolimab received marketing authorization from the chinese national medical products administration (nmpa) for the treatment of previously treated msi-h/dmmr advanced solid tumors.
the company also has state-of-the-art manufacturing capabilities designed and built to meet nmpa and eu/fda’s cgmp standards and a complete quality system which has passed the on-site inspection of a european union qualified person. alphamab oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in china and around the world.
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