Adding chemotherapy to first-line durvalumab plus tremelimumab did not improve overall survival (OS) in patients with stage IV non-small cell lung cancer (NSCLC), according to research published in the Journal of Thoracic Oncology.

However, the chemotherapy regimen did improve the overall response rate (ORR) and progression-free survival (PFS) when compared with immunotherapy alone.

This phase 2 trial (ClinicalTrials.gov Identifier: NCT03057106) was designed to evaluate the efficacy and safety of adding platinum doublet chemotherapy to first-line treatment with durvalumab plus tremelimumab.


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The trial enrolled 301 patients with treatment-naïve, metastatic NSCLC without sensitizing EGFR or ALK alterations. The patients had a median age of 64 years (range, 27-87 years), 53.8% were men, 70.4% had stage IVB disease, and 81.7% had non-squamous NSCLC.

Patients were randomly assigned to treatment with durvalumab, tremelimumab, and chemotherapy (151 patients) or durvalumab-tremelimumab only (150 patients). Baseline characteristics were generally well balanced between the arms.

The median duration of treatment was 7.4 months in the chemotherapy arm and 3.3 months in the durvalumab-tremelimumab arm. The median follow-up was 16.6 months.

The ORR was significantly higher in the chemotherapy arm than in the durvalumab-tremelimumab arm — 42.4% and 29.3%, respectively (odds ratio, 1.69; 95% CI, 1.04-2.76). However, the median duration of partial response was similar between the arms — 8.2 months and 7.7 months, respectively. 

The median PFS was significantly longer in the chemotherapy arm than in the durvalumab-tremelimumab arm — 7.7 months and 3.2 months, respectively (hazard ratio [HR], 0.67, 95% CI, 0.52-0.88; P =.003).

However, there was no significant difference in OS between the arms. The median OS was 16.6 months in the chemotherapy arm and 14.1 months in the durvalumab-tremelimumab arm (HR, 0.88; 90% CI, 0.67-1.16; P =.46). The 1-year OS rate was 59% and 55%, respectively.

The rate of grade 3 or higher adverse events (AEs) was 82% in the chemotherapy arm and 70% in the durvalumab-tremelimumab arm. The rate of treatment discontinuation due to AEs was 23% and 14%, respectively.

There were 5 treatment-related deaths in the chemotherapy arm and 3 in the durvalumab-tremelimumab arm.

Disclosures: This research was partially supported by AstraZeneca. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Leighl NB, Laurie SA, Goss GD, et al. CCTG BR34: A randomized phase II trial of durvalumab and tremelimumab +/-platinum-based chemotherapy in patients with metastatic non-small cell lung cancer. J Thorac Oncol. Published online November 17, 2021. doi:10.1016/j.jtho.2021.10.023