Durvalumab led to durable responses in patients with heavily treated metastatic non-small cell lung cancer (NSCLC), according to results presented at the International Association for the Study of Lung Cancer (IASLC) 17th Annual World Conference on Lung Cancer in Austria.1 Activity was greater for patients who had PD-L1 expression in more than 25% of tumor cells.
Marina Garassino, MD, the European Society for Medical Oncology (ESMO) representative in Italy, presented the results of the phase 2 ATLANTIC trial (ClinicalTrials.gov Identifier: NCT02087423), in which the efficacy of durvalumab, a PD-L1 inhibitor, was studied in highly pretreated patients with NSCLC.
Researchers initially enrolled any patients with NSCLC, but following phase 1, the study was restricted to patients whose tumors showed high PD-L1 expression. Three cohorts were included in the study.
Dr Garassino reported on results for the 2 cohorts in which patients had EGFR/ALK wild-type or unknown status. Cohort 2 included 2 subgroups: patients with PD-L1 expression in at least 25% of tumor cells, and patients with PD-L1 in less than 25%. Cohort 3 included patients with PD-L1 in at least 90% of tumor cells.
The study’s primary endpoint is overall response rate (ORR).
As of 3 June 2016, in cohorts 2 and 3, 265 and 68 patients had received durvalumab, respectively. Responses were durable: in cohort 2, the ORR was similar in patients with squamous and non-squamous histology.
In cohort 2, patients with PD-L1 in less than 25% of tumor cells had a median progression-free survival (PFS) of 1.9 months, while those with PD-L1 of at least 25% had a median PFS of 3.3 months. In cohort 3, patients had a median PFS of 2.4 months.
Dr Garassino said that these results are consistent with those for other anti-PD-1/PD-L1 therapies for patients with metastatic, relapsed NSCLC and support further development of durvalumab.
- Garassino MC, Vansteenkiste JF, Kim J, et al. Durvalumab in ≥3rd-line locally advanced or metastatic, EGFR/ALK wild-type NSCLC: results from the phase 2 ATLANTIC study. Paper presented at: International Association for the Study of Lung Cancer 17th World Conference on Lung Cancer; December 2016; Vienna, Austria.