Durvalumab is a high-affinity, fully human IgG1κ monoclonal antibody that specifically targets programmed death-ligand 1 (PD-L1), a key biomarker in the regulation of immune checkpoints. By inhibiting the interaction between PD-L1 and its receptors PD-1 and CD80, durvalumab enables T cells to recognize and destroy tumor cells. It plays a critical role in cancer immunotherapy, especially for patients with tumors that overexpress PD-L1, such as advanced non-small cell lung cancer (NSCLC) and urothelial carcinoma.
In clinical and research settings, PD-L1 expression is routinely assessed as a predictive biomarker for durvalumab eligibility and treatment response. Patients with ≥1% PD-L1 expression in tumor cells are considered suitable candidates for durvalumab therapy. Its mechanism of action supports the reactivation of immune responses following chemotherapy or radiotherapy, offering synergistic potential in combined treatment regimens. Durvalumab is used as monotherapy or in combination protocols, with therapeutic drug monitoring (TDM) recommended to assess efficacy and identify immune-related adverse effects or noncompliance.
Given its biologic nature, durvalumab’s immunogenicity must be monitored through anti-drug antibody (ADA) testing. The emergence of neutralizing antibodies can impact therapeutic efficacy and safety. Biosimilar development of durvalumab also requires rigorous biomarker validation to ensure comparable immunogenicity and clinical performance to the reference product.
This product is manufactured in Turkey by Matriks Biotek.