On 25 November 2021, 3D Medicines (Beijing) Co., Ltd. (3DMed), Alphamab Oncology, and Simcere Pharmaceutical Group Limited (Simcere) jointly announced that Envafolimab (KN035), the world's first single-domain PD-L1 antibody formulated for subcutaneous injection (SC) co-developed by the three companies, has received marketing authorization from the Chinese National Medical Products Administration (NMPA). As a leader of local medical imaging CRO in China, FAB provided a full range of independent medical imaging services for the clinical trials of the drug.
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.
Currently, all marketed PD-1 and PD-L1 antibody drugs are marketed as intravenous injectable (IV) in China and globally. The average time for administration is 0.5-2 hours.
As the world's first SC PD-L1 antibody, Envafolimab can be administered within 30 seconds—significantly shortening treatment time, while sparing the patients from various adverse reactions arising from intravenous infusion. It provides an alternative treatment option for the cancer patients who are intolerant to IV injection and have otherwise no accessibility to immunotherapy. 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.
A pivotal phaseⅡclinical study, led by Professor Lin Shen from Peking University Cancer Hospital and Institute，has evaluated the efficacy and safety of Envafolimab in patients with advanced dMMR/MSI-H tumors. The updated clinical data presented at CSCO 2021 showed that the Objective Response Rate (ORR) of patients who received Envafolimab as second or later-line treatment is 44.7%, including 12 (11.7%) cases of Complete Response (CR). The responses were durable, and the rates of durable response at 12 months in patients with advanced colorectal cancer (CRC), advanced gastric cancer, other advanced solid tumors, and all patients were 89.3%, 100%, 100%, and 93.2%, respectively. The median progression-free survival (PFS) was 11.1 months, 12-month overall survival (OS) rate was 73.6%. Envafolimab was well tolerated in this study with no cases of immune-related pneumonitis, immune-related colitis, or immune-related nephritis reported.
As the leading and first established imaging CRO in China, FAB is honored to participate in the clinical trial project of Envafolimab, and has carried out in-depth cooperation with 3DMed in central imaging.
During the project implementation process, FAB takes advantage of its professional advantages to meet the requirements of the project in terms of science, quality and time frame in all aspects with high standards, high efficiency and high quality, providing accurate and reliable independent evaluation results to speed up the progress of product launch declaration. For example, during the high-speed entry phase of the project, due to the short entry screening period, the evaluation results are usually required the next morning after receiving the image data in the afternoon. In order to match the progress and plan of hundreds of enrollment cases, members of the project team responded immediately after receiving the data, even working late into the night to complete the task of the day. FAB, as the central imaging IRC, always adheres to the principles of 'complete, high-quality imaging data, thorough interpretation of assessment criteria, full understanding of the imaging characteristics of the trial drug, combined with scientific design and assessment methods to make a true, correct, and reliable assessment of efficacy' to provide professional, accurate, and timely efficacy assessment for this product. The final IRC assessment results were highly consistent with clinical efficacy and successfully met the study endpoint.
FAB team was highly recognized and appreciated by the sponsor team, and PM received several letters of appreciation from the sponsor for its service consciousness, scientific and rigorous thinking, and positive attitude in coordinating problem solving during the project, which played an important role in the enrollment and study results.
Since its establishment nearly ten years ago, FAB has accumulated rich project experience. At present, 25 projects have been successfully submitted to the FDA/NMPA for application, and 17 projects have been approved for marketing, covering multiple disease areas.In the future, FAB will continue to use professional, efficient and comprehensive independent medical imaging services to help sponsors accelerate their clinical trials so that more quality new drugs can be approved faster for the benefit of patients.
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