On December 4, 2024, the Food and Drug Administration sanctioned durvalumab (Imfinzi, AstraZeneca) for adults with limited-stage small cell lung cancer (LS-SCLC) whose condition remains stable after concurrent platinum-based chemotherapy and radiation therapy.
Efficacy and Safety
The efficacy was assessed in ADRIATIC (NCT03703297), a randomized, double-blind, placebo-controlled trial involving 730 patients with LS-SCLC whose condition had not advanced after concomitant platinum-based chemotherapy and radiation therapy. Patients were randomized in a 1:1:1 ratio to receive either durvalumab as a monotherapy, durvalumab in conjunction with tremelimumab, or a placebo.
The primary effectiveness endpoints were overall survival (OS) and progression-free survival (PFS), evaluated through blinded independent central review, comparing durvalumab monotherapy to placebo. Durvalumab exhibited a statistically significant improvement in overall survival (OS) vs to placebo, with a hazard ratio (HR) of 0.73 (95% CI: 0.57, 0.93; p-value 0.0104).
The median overall survival (OS) was 55.9 months (95% confidence interval: 37.3, not reached) in the durvalumab group and 33.4 months (95% confidence interval: 25.5, 39.9) in the placebo group. Durvalumab also demonstrated a statistically significant PFS improvement compared to placebo with HR of 0.76 (95% CI: 0.61, 0.95; p-value 0.0161). The median progression-free survival (PFS) was 16.6 months (95% confidence interval: 10.2, 28.2) for the durvalumab group and 9.2 months (95% confidence interval: 7.4, 12.9) for the placebo group, respectively.
The predominant adverse effects (≥20%) were pneumonitis or radiation pneumonitis and tiredness.
The advised dosage of durvalumab is 1,500 mg every four weeks for individuals weighing ≥30 kg and 20 mg/kg every four weeks for those weighing <30 kg, continuing until disease progression, intolerable toxicity, or a maximum duration of 24 months.
Susan Hau is a distinguished researcher in the field of cancer cell therapy, with a particular focus on T cell-based approaches and cancer vaccines. Her work spans several innovative treatment modalities, including CAR T-cell therapy, TIL (Tumor-Infiltrating Lymphocyte) therapy, and NK (Natural Killer) cell therapy.
Hau's expertise lies in cancer cell biology, where she has made significant contributions to understanding the complex interactions between immune cells and tumors.
Her research aims to enhance the efficacy of immunotherapies by manipulating the tumor microenvironment and exploring novel ways to activate and direct immune responses against cancer cells.
Throughout her career, Hau has collaborated with leading professors and researchers in the field of cancer treatment, both in the United States and China.
These international experiences have broadened her perspective and contributed to her innovative approach to cancer therapy development.
Hau's work is particularly focused on addressing the challenges of treating advanced and metastatic cancers. She has been involved in clinical trials evaluating the safety and efficacy of various immunotherapy approaches, including the promising Gamma Delta T cell therapy.
