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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.
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.
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About Sai Sree
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