Health Canada has granted a Notice of Compliance (NOC) for AstraZeneca Canada’s IMFINZI® (durvalumab), as monotherapy, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT), following a priority review of the submission.
The approval of Imfinzi was granted based on results from the pivotal ADRIATIC Phase III trial which demonstrated statistically significant and clinically meaningful results for its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for Imfinzi compared with placebo. The results of the ADRIATIC trial were presented during the Plenary Session of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and subsequently published in the New England Journal of Medicine.
SCLC is a highly aggressive form of lung cancer. LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy. The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients will be alive five years after diagnosis.
"With this approval, we can now offer immunotherapy treatment to people living with limited-stage small cell lung cancer, which is almost always fatal, even in patients with limited disease burden," says Dr. Shantanu Banerji, Director of Precision Oncology and Advanced Therapeutics, CancerCare Manitoba. "The ADRIATIC trial demonstrated that Imfinzi can offer improved survival and greater odds of cure for these patients, the first major advance for this disease in close to 40 years."
In the ADRIATIC trial, Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; P=0.0104). The estimated median OS was 55.9 months for the Imfinzi arm versus 33.4 months for the placebo arm. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo.
Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; P=0.0161) versus placebo. Median PFS was 16.6 months for the Imfinzi arm versus 9.2 months for the placebo arm. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.
The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were identified for Imfinzi in patients with LS-SCLC. The proportion of patients with adverse events leading to discontinuation of study treatment was 16.4% in the Imfinzi arm. The most common adverse events reported in the ADRIATIC study (any Grade; occurring in ≥10% of patients) for the Imfinzi arm were: pneumonitis or radiation pneumonitis, decreased appetite, hypothyroidism, cough, pruritus, nausea, dizziness, fatigue, diarrhea, pneumonia, rash, constipation and hyperthyroidism.
"This approval is great news for people living with this form of lung cancer and their families," says Shem Singh, Executive Director, Lung Cancer Canada. "The opportunity to live longer and with better outcomes is a significant advancement and a critical new treatment option for this aggressive disease, which has traditionally been known for its high rates of recurrence."
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