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Durvalumab-tremelimumab combination fails to prolong survival in PD-L1-low non-small cell lung cancer
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The combination of durvalumab and tremelimumab did not confer clinically meaningful improvement in PFS or OS compared with standard chemotherapy for a subgroup of patients with previously treated non-small cell lung cancer, according to study results released by the agents’ manufacturer.
Durvalumab (Imfinzi, AstraZeneca) is a PD-L1-blocking antibody, and tremelimumab (MedImmune/AstraZeneca) is a human monoclonal antibody that targets CTLA-4.
The randomized phase 3 ARCTIC trial included patients with locally advanced or metastatic NSCLC who received at least two prior treatments.
One substudy included patients with PD-L1 expression less than 25%. Researchers randomly assigned these patients 2:3:1:2 to the combination of durvalumab plus tremelimumab, durvalumab monotherapy, tremelimumab monotherapy or standard chemotherapy.
This substudy did not meet the primary endpoints of a statistically significant and clinically meaningful improvement in PFS or OS with the combination regimen compared with chemotherapy.
The activity and safety of durvalumab monotherapy and tremelimumab monotherapy appeared consistent with previously published data.
A second substudy included patients with PD-L1 expression of 25% or higher. Researchers assigned patients to durvalumab monotherapy or standard chemotherapy.
Although this substudy was not powered for statistical significance, results showed durvalumab monotherapy conferred a clinically meaningful reduction in risk for death compared with chemotherapy.
Full efficacy and safety results from the ARCTIC trial will be presented at a medical meeting.
“[Although] we are disappointed that the combination of [durvalumab] plus tremelimumab did not result in a statistically significant survival benefit in this heavily pretreated patient population, we are encouraged by the activity of [durvalumab] monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting,” Sean Bohen, executive vice president of global medicines development and chief medical officer of AstraZeneca, said in a company-issued press release.