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Durvalumab alone or with tremelimumab fails to extend OS in metastatic lung cancer
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A randomized phase 3 trial designed to compare durvalumab as monotherapy or in combination with tremelimumab with standard platinum-based chemotherapy for treatment-naive patients with metastatic non-small cell lung cancer failed to meet its primary endpoint of OS.
The open-label, multicenter MYSTIC trial included patients with epidermal growth factor receptor and anaplastic lymphoma kinase wild-type, locally advanced or metastatic NSCLC.
Researchers assigned patients to monotherapy with durvalumab (Imfinzi, AstraZeneca/MedImmune), a human monoclonal antibody that binds to PD-L1; a combination of durvalumab and tremelimumab (AstraZeneca/MedImmune), a human monoclonal antibody that targets CTLA-4; or standard chemotherapy as first-line treatment.
Neither experimental regimen conferred a statistically significant OS benefit compared with chemotherapy in the primary population of patients whose tumors expressed PD-L1 on 25% or more of their cancer cells (combination: HR = 0.85; 98.77% CI, 0.61-1.17; durvalumab monotherapy: HR = 0.76; 97.54% CI, 0.56-1.02).
The safety profiles for durvalumab monotherapy and the durvalumab-tremelimumab combination appeared consistent with observations from prior studies.
“We are encouraged to see that Imfinzi monotherapy activity is in-line with that of the anti-PD-1 class in previously untreated patients with stage IV non-small cell lung cancer; however, we are disappointed that these results missed statistical significance,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a company-issued press release. “We remain confident in Imfinzi as the cornerstone of our immuno-oncology program and continue to evaluate its potential in ongoing non-small cell lung cancer trials, including Imfinzi and Imfinzi plus tremelimumab in combination with chemotherapy.”
Durvalumab is approved in the United States for treatment of unresectable stage III NSCLC. Several phase 3 trials are underway to evaluate the agent as treatment for patients with stage IV NSCLC.