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Publication: BR34

The CCTG BR34: A randomized phase II trial of durvalumab and tremelimumab +/- platinum-based chemotherapy in patients with metastatic non-small cell lung cancer study results were recently published in the Journal of Thoracic Oncology.

Natasha B. Leighl, MD; Scott A. Laurie, MD; Glenwood D. Goss, MD; Brett G.M. Hughes, MBBS ; Martin Stockler, MBBS ; Ming-Sound Tsao, MD ; David M. Hwang, MD ; Phillipe Joubert, MD ; Swati Kulkarni, MD ; Normand Blais, MD  Anil A. Joy, MD ; Mihaela Mates, MD ; Punam Rana, MD ; Sunil K. Yadav, MD ; Craig Underhill, MBBS ;  Christopher Lee, MD ; Penelope A. Bradbury, MB  ; Andrea Hiltz, MSc ; Janet Dancey, MD ; Keyue Ding, PhD ; Francisco Vera-Badillo, MD

To access the BR34 Online Publication

In collaboration with the Australian Lung Cancer Trials Group, approximately 300 lung patients from Canada and Australia where treated with a combination immunotherapy and added chemotherapy to half T(randomized to combination IO +/- chemotherapy) as first line treatment in advanced lung cancer patients and was conducted. First-line therapy for patients with metastatic non-small cell lung cancer(NSCLC) includes checkpoint inhibitor monotherapy, dual checkpoint inhibition or in combination with chemotherapy. The study compared outcomes with combination chemo-immunotherapy versus dual checkpoint inhibition as first-line treatment for patients with metastatic NSCLC.

"Through this study we showed that patients did not live longer with chemotherapy so there may be a way forward to selecting more patients for an immunotherapy/chemotherapy-free approach for first-line therapy," says study lead Dr. Natasha B. Leighl at Princess Margaret Cancer Centre.

Results

301 patients were randomized. Median OS was 16.6 months (95%CI, 12.6-19.1) with chemotherapy plus immunotherapy and 14.1 months (95%CI, 10.6-18.3) with immunotherapy, (HR 0.88, 90%CI, 0.67-1.16; P=0.46). Median PFS with chemotherapy plus immunotherapy was 7.7 months (95%CI, 5.5-8.5) and 3.2 months (95%CI, 2.7-5.1) with immunotherapy, (HR 0.67, 95%CI, 0.52-0.88). The ORR with chemoimmunotherapy was 42.4% and 29.3% with immunotherapy, (adjusted odds ratio 1.69, 95%CI, 1.04-2.76). The percentage of patients with grade
3 adverse events was 82% in the chemotherapy plus immunotherapy group and 70% in the immunotherapy group. Exploratory analyses of PD-L1 expression and bTMB revealed no differential treatment effect on OS.

Conclusions

The addition of chemotherapy to durvalumab plus tremelimumab in the first-line treatment of stage IV NSCLC did not improve survival compared to durvalumab plus tremelimumab alone. Further study is warranted to identify patients that benefit from initial immunotherapy alone versus combination chemotherapy plus immunotherapy as first-line treatment.