Virtual Library
Start Your Search
J. Powderly
Author of
-
+
PL04a - Plenary Session: Immune Checkpoint Inhibitors in Advanced NSCLC (ID 430)
- Event: WCLC 2016
- Type: Plenary
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:J. Soria, C. Zhou
- Coordinates: 12/07/2016, 08:45 - 09:40, Hall D (Plenary Hall)
-
+
PL04a.03 - Durvalumab in ≥3rd-Line Locally Advanced or Metastatic, EGFR/ALK Wild-Type NSCLC: Results from the Phase 2 ATLANTIC Study (Abstract under Embargo until December 7, 7:00 CET) (ID 5336)
09:05 - 09:15 | Author(s): J. Powderly
- Abstract
- Presentation
Background:
Treatment with anti-PD-1/PD-L1 antibodies has demonstrated meaningful clinical benefit in patients with advanced NSCLC. Patients that progress after 2 lines of chemotherapy have few treatment options and poor outcomes. Durvalumab is an engineered human IgG1 mAb targeting programmed cell death ligand-1 (PD-L1).
Methods:
ATLANTIC (NCT02087423) is a Phase 2, open-label, single-arm trial in patients with locally advanced or metastatic Stage IIIB–IV NSCLC (WHO PS 0 or 1; ≥2 prior systemic treatment regimens, including one platinum-based). There was no maximum number of prior treatments. The study initially enrolled all-comers and then was restricted to patients with PD-L1 high tumours (≥25% of tumour cells with membrane staining). The study includes three cohorts; here we report final results in Cohorts 2 and 3 that had EGFR/ALK wild-type or unknown status. Patients enrolled in Cohort 3 had ≥90% of tumour cells with PD-L1 staining. The primary endpoint is ORR (RECIST v1.1), based on independent central review. Secondary endpoints include DCR, DoR, PFS, OS, and safety (CTCAE v4.03).
Results:
As of 3 June 2016, in Cohorts 2/3, 265/68 patients (median age 62/61 years, 67/72% PS 1, 21/29% squamous histology; mean of 3.2/2.6 prior therapies) had received durvalumab (10 mg/kg i.v. q2w). Responses were durable; in Cohort 2, patients with PD-L1 ≥25%, the ORR was similar in patients with squamous and non-squamous histology.
Most AEs were low grade and resolved with treatment delay and/or immunosuppressive interventions. Overall, 10.2% of patients had Grade ≥3 treatment-related AEs and 2.7% had treatment-related AEs leading to discontinuation.Cohort 2 Cohort 3 PD-L1 high (≥25%) PD-L1 low/negative (<25%) PD-L1 ≥90% n=146 n=93 n=68 ORR,* %(95%CI) 16.4(10.8-23.5) 7.5(3.1-14.9) 30.9(20.2-43.3) DCR, %(95%CI) 28.8(21.6-36.8) 20.4(12.8-30.1) 38.2(26.7-50.8) mDoR, months(25[th], 75[th] percentile) 12.3(7.5-NR) NR(7.2-NR) NR; 18/21 responders progression free at DCO n=149 n=94 n=67 mPFS, months(95%CI) 3.3(1.9-3.7) 1.9(1.8-1.9) 2.4(1.8-5.5) mOS, months(95%CI) 10.9(8.6-13.6) 9.3(5.9-10.8) NR(5.9-NC) 1-year OS, %(95%CI) 47.7(39.3-55.5) 34.5(25.0-44.1) 50.8(36.9-63.2) mFollow-up for OS, months 9.4 9.3 7.0 *Confirmed response per independent central review. DCO=data cutoff; DCR=disease control rate (complete response, partial response or stable disease ≥24 weeks); DoR=duration of response; m=median; NC=not calculated; NR=not reached; ORR=objective response rate; OS=overall survival; PFS=progression-free survival
Conclusion:
Durvalumab was active and led to durable responses in a heavily pretreated metastatic NSCLC population; activity was numerically greater for patients whose tumours exceeded the 25% PD-L1 cutoff. The tolerability profile was manageable. Results are consistent with other anti-PD-1/PD-L1 therapies in metastatic, relapsed NSCLC and support further development of durvalumab.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
