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Durvalumab plus tremelimumab fails to improve PFS in metastatic non-small cell lung cancer
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The combination of durvalumab and tremelimumab failed to extend PFS compared with first-line chemotherapy among treatment-naive individuals with metastatic non-small cell lung cancer, according to phase 3 study results.
The randomized, open-label, multicenter phase 3 MYSTIC trial evaluated the efficacy of durvalumab (Imfinzi, AstraZeneca) — a human monoclonal antibody directed against PD-L1 — as monotherapy or in combination with tremelimumab (MedImmune), an investigational human monoclonal antibody that targets CTLA-4 activity.
Researchers compared the regimens with standard chemotherapy for previously untreated patients with epidermal growth factor receptor and anaplastic lymphoma kinase wild-type locally advanced or metastatic NSCLC.
PFS served as the primary endpoint.
The combination of durvalumab and tremelimumab failed to improve PFS among patients whose tumors expressed PD-L1 on 25% or more of their cancer cells compared with standard chemotherapy.
Although not formally tested, durvalumab monotherapy would not have met a prespecified threshold of PFS benefit compared with chemotherapy in this patient population, according to an AstraZeneca-issued press release.
Researchers involved with the trial will continue to evaluate OS for both the monotherapy and combination regimens. Data are expected next year.
“[Although] the results from the MYSTIC trial for PFS in first-line stage IV NSCLC compared with standard of care are disappointing, the trial was designed to assess overall survival,” Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in the release. “We look forward to evaluating the remaining primary endpoints of overall survival for both [monotherapy] and combination therapy.”