The phase 2 ATLANTIC study has investigated the anti-PD-L1 antibody Durvalumab ( Imfinzi ) in heavily pretreated patients with advanced non-small cell lung cancer ( NSCLC ).
Researchers have reported updated results for two of the three patient cohorts ( defined by tumor PD-L1 expression and EGFR/ALK mutation status ) for which data have reached further maturity.
ATLANTIC is an open-label, single-arm trial of advanced NSCLC patients who had progressed after 2 regimens or more.
After initially enrolling all-comers, the study was restricted to patients with PD-L1-expressing tumors ( greater than or equal to 25% of tumor cells [ TC ] ).
Patients received Durvalumab 10 mg/kg IV every 2 weeks for 12 months or less.
The primary endpoint was objective response rate ( ORR ) by independent central review ( ICR ) using RECIST v1.1 in patients with TC 25% or more.
Patients in Cohort 1 were EGFR+/ALK+ and patients in Cohorts 2 ( not reported ) and 3 ( TC 90% or more, only ) were EGFR−/ALK−.
Interim results were reported for a prior data cutoff ( DCO; June 3, 2016 ).
As of the latest DCO ( November 7, 2017 ), 444 patients had received Durvalumab, 111/68 in cohorts 1/3.
Median age was 61.0 years in both cohorts, 0.9%/29.4% had squamous histology, and the mean number of prior therapies in each cohort was 3.8/2.6.
Median overall survival ( OS ) was 13.3/13.2 months, with a 1-year overall survival rate of up to 53%, in patients with higher PD-L1 expression.
Grade 3 or more treatment-related adverse effects ( CTCAE v4.03 ) occurred in 5.4%/19.1%.
Immune-mediated adverse effects were manageable, occurring with similar incidences as that reported previously for the earlier DCO.
In conclusion, these findings have demonstrated durable efficacy and a promising effect on overall survival with Durvalumab in a subset of heavily pretreated, advanced NSCLC patients. ( Xagena )
Source: American Society of Clinical Oncology - ASCO Meeting, 2018