Adjuvant durvalumab extends survival in limited-stage small cell lung cancer
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Key takeaways:
- Treatment with durvalumab improved PFS and OS compared with placebo.
- Incidence of grade 3 or grade 4 adverse events appeared comparable between groups.
Adjuvant durvalumab significantly improved PFS and OS compared with placebo among patients with limited-stage small cell lung cancer, according to study results presented at ESMO Congress.
Durvalumab (Imfinzi, AstraZeneca) is a human monoclonal antibody that binds to PD-L1.
It is approved in the United States for multiple oncology indications, including treatment of certain patients with NSCLC, small cell lung cancer, bile duct cancer, gallbladder cancer, hepatocellular carcinoma or endometrial cancer.
The randomized phase 3 ADRIATIC trial included 730 patients with limited-stage small cell lung cancer who did not have disease progression after standard concurrent platinum-based chemoradiotherapy.
Researchers assigned 264 patients to 1,500 mg durvalumab every 4 weeks for up to 24 months. They assigned 200 patients to 1,500 mg durvalumab every 4 weeks for up to 24 months plus 75 mg tremelimumab (Imjudo, AstraZeneca) for a maximum four doses. The other 266 patients received placebo.
Investigators stratified randomization according to disease stage and receipt of prophylactic cranial irradiation. PFS and OS served as primary endpoints.
The first planned interim analysis — results of which were presented at ESMO and published in The New England Journal of Medicine — focused on the comparison between durvalumab monotherapy and placebo.
Results showed longer median PFS (16.6 months vs. 9.2 months; HR = 0.76; 97.195% CI, 0.59-0.98) and OS (55.9 months vs. 33.4 months; HR = 0.73; 98.321% CI, 0.54-0.98) among patients assigned durvalumab.
A comparable percentage of patients assigned durvalumab and placebo experienced grade 3 or grade 4 adverse events (24.4% vs. 24.2%). A higher percentage of patients in the durvalumab group experienced adverse events that led to treatment discontinuation (16.4% vs. 10.6%). A comparable percentage of patients died in each group (2.7% vs. 1.9%).
Results from the cohort assigned durvalumab-tremelimumab remained blinded at the time of the interim analysis.
References:
- Cheng Y, et al. Abstract LBA81. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
- Cheng Y, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2404873.
Perspective
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Hossein Borghaei, DO, MS
This is a significant, practice-changing study. For patients with small cell lung cancer, progress improving survival has been slow. In this aggressive malignancy, trials like ADRIATIC provide some evidence that, in the right setting, immunotherapy can be effective for improving survival. This is very helpful for our patients.
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Cheng Y, et al. Abstract LBA81. Presented at: European Society for Medical Oncology Congress; Sept. 13-17, 2024; Barcelona, Spain.
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