From the Guidelines
Envafolimab is recommended as a treatment option for patients with dMMR/MSI-H colorectal cancer, administered as a 150mg subcutaneous injection on day 1, repeated weekly 1.
Key Points
- Envafolimab is a potential treatment option for patients with dMMR/MSI-H colorectal cancer.
- The recommended dosage is 150mg, administered via subcutaneous injection on day 1, repeated weekly.
- This treatment option is specifically for patients with dMMR/MSI-H colorectal cancer, as indicated in the Chinese Society of Clinical Oncology (CSO) clinical guidelines for the diagnosis and treatment of colorectal cancer, 2024 update 1.
Mechanism of Action
- Envafolimab works by targeting the PD-L1 pathway, which is involved in the immune response against cancer cells.
- By inhibiting the PD-L1 pathway, Envafolimab can help to restore the immune system's ability to recognize and attack cancer cells.
Clinical Evidence
- The clinical evidence for Envafolimab is based on studies such as the one published in the Journal of Clinical Oncology, which demonstrated the efficacy and safety of Envafolimab in patients with dMMR/MSI-H colorectal cancer 1.
- Additionally, the Chinese Society of Clinical Oncology (CSO) clinical guidelines for the diagnosis and treatment of colorectal cancer, 2024 update, recommend Envafolimab as a treatment option for patients with dMMR/MSI-H colorectal cancer 1.
Important Considerations
- Envafolimab is only recommended for patients with dMMR/MSI-H colorectal cancer, and its use in other types of cancer or patient populations is not established.
- Patients should be closely monitored for adverse reactions and toxicity while receiving Envafolimab treatment.
From the Research
Overview of Envafolimab
- Envafolimab is a subcutaneously administered single-domain anti-programmed death ligand 1 (PD-L1) antibody being developed for the treatment of various solid tumours and chronic hepatitis B in China, and for soft tissue sarcomas and biliary tract cancer in the USA 2.
- It is the first and only globally approved subcutaneously injectable PD-L1 antibody 3.
Clinical Trials and Efficacy
- A phase II trial showed that envafolimab monotherapy exhibited satisfactory clinical therapeutic effects and no significant adverse events in patients with microsatellite instability-high/deficient mismatch Repair (MSI-H/dMMR) solid tumors who failed at least one line of prior systemic therapy 4.
- A pivotal phase II study found that envafolimab was effective and had acceptable safety in the treatment of previously treated advanced dMMR/MSI-H solid tumors, with an objective response rate of 42.7% and a disease control rate of 66.0% 5.
- A first-in-human phase I study demonstrated that subcutaneous envafolimab was well tolerated and had durable antitumor activity at a wide range of doses and schedules, with a favorable pharmacokinetic profile 6.
Safety and Pharmacokinetics
- Envafolimab was well tolerated, with no dose-limiting toxicities or injection-site reactions reported in clinical trials 3, 6.
- The safety profile of envafolimab was similar to that of other traditional antibodies, with no new safety signals identified 3.
- Envafolimab demonstrated dose-proportional increases in area under the time-concentration curve and maximum plasma concentration, with a median time to maximum plasma concentration of 4-7 days 6.
Potential Benefits
- Envafolimab offers a more convenient treatment option than currently available intravenously administered PD-1/PD-L1 inhibitors, with the potential to improve patient compliance and outcomes 3, 4.
- As the first single-domain PD-L1-targeting antibody administered by rapid subcutaneous injection, envafolimab has the potential to be a significant advance in the treatment of cancer 5.