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M. Garassino

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    ESMO-IASLC Best Abstracts (ID 48)

    • Event: ELCC 2017
    • Type: Best abstracts session
    • Track:
    • Presentations: 1
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      82O - Durvalumab in ≥ 3rd-line EGFR mutant/ALK+, locally advanced or metastatic NSCLC: Results from the phase 2 ATLANTIC study (ID 263)

      16:45 - 18:15  |  Author(s): M. Garassino

      • Abstract
      • Presentation
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      Anti-PD-1/PD-L1 therapies have demonstrated meaningful clinical benefit in pts with EGFR/ALK wild-type (WT) advanced NSCLC. However, to our knowledge these agents have never been investigated in a study prospectively focusing on NSCLC pts with EGFR mutations or ALK alterations (EGFRmut/ALK+), a distinct subgroup with clear biological and treatment outcome differences compared with EGFR/ALK WT pts. Durvalumab is an engineered human IgG1 mAb targeting PD-L1.

      ATLANTIC (NCT02087423) was a Phase 2, open-label, single-arm trial in pts with locally advanced or metastatic Stage IIIB–IV NSCLC (WHO PS 0 or 1; ≥2 prior systemic regimens, including 1 platinum-based and 1 TKI [EGFRmut/ALK+ pts]). There was no maximum number of prior treatments. The study initially enrolled all-comers and then was restricted to pts with PD-L1 high tumours (≥25% of tumour cells with membrane staining). The study included 3 pt cohorts defined by EGFR/ALK status and tumor PD-L1 expression; here we report results from EGFRmut/ALK+ pts (Cohort 1). The primary outcome was ORR (RECIST v1.1). Secondary outcomes included DCR, DoR, PFS, OS, and safety (CTCAE v4.03).

      As of 3 June 2016, 111 pts (median age 61 years, 63% female, 59% WHO PS 1, 99% non-squamous histology; 59% never smokers; mean prior therapies 3.8) had received durvalumab (10 mg/kg i.v. q2w for ≤12 months). Responses were durable. Most AEs were low grade. Immune-mediated AEs were manageable with standard treatment guidelines; 5.4% of pts had Grade ≥3 treatment-related (TR) AEs and 0.9% had TRAEs leading to discontinuation.rnTable: 82Orn

      rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn rnrn
      rnPD-L1 high (≥25%)PD-L1 low/negative (<25%)
      n = 74[a]n = 28[a]
      ORR,[b] % (95% CI)12.2 (5.7, 21.8)3.6 (0.1, 18.3)
      DCR, % (95% CI)20.3 (11.8, 31.2)7.1 (0.9, 23.5)
      mDoR, months (95% CI)7.4 (5.4, 9.2)NC[c]
      rnn = 77[d]n = 30[d]
      mPFS, months (95% CI)1.9 (1.8, 3.6)1.9 (1.8, 1.9)
      mOS, months (95% CI)13.3 (8.1, NC)9.9 (4.2, 13.0)
      1-year OS, % (95% CI)54.8 (41.5, 66.3)40.0 (22.1, 57.4)
      mFollow-up for OS, months6.58.2
      rnNote: 4 patients had PD-L1 expression unknown or missing.rnaFull analysis set - evaluable for response per independent central review (ICR).rnbConfirmed response per ICR.rncNot calculated due to small number of responders.rndFull analysis set.rnDCR=disease control rate (complete response, partial response or stable disease ≥24 weeks); DoR=duration of response; m=median; NC=not calculated; ORR=objective response rate; OS=overall survival; PFS=progression-free survivalrn

      Although the ORR was somewhat lower compared with that reported in Cohort 2 (EGFR/ALK WT), durable responses were still observed in this heavily pretreated metastatic EGFRmut/ALK+ NSCLC population. However, the data were limited by the short duration of follow up and further confirmation is needed. Activity was greater for pts with high PD-L1 expression. The tolerability profile was manageable.

      Clinical trial identification:
      NCT02087423 (March 4, 2014)

      Legal entity responsible for the study:
      AstraZeneca PLC


      M.C. Garassino: Grants/research support: Pfizer; Consultant: Eli Lilly; AZ, BMS, MSD, Roche, Celgene. B-C. Cho: Grants/Research: AZ, BI, Yuhan, Roche, MSD, BMS Ono, Eli Lilly, Pfizer, Bayer Consultant: AZ, BI, Yuhan, Roche, MSD, BMS Ono, Eli Lilly, Pfizer Honoraria: AZ, BI, Yuhan, Roche, MSD, BMS Ono, Eli Lilly, Pfizer. J. Mazières: Advisory board: AZ. K. Park: Advisory role: Astellas, AZ, BI, Clovis, Lilly, Hanmi, AZ, Kyowa Hakko Kirin, Novartis, Ono, Roche Speaker bureau: BI Research: AZ. R.A. Soo: Grants/research support: AZ Honoraria: AZ, BI, BMS, Lilly, Pfizer, Roche, Taiho, Novartis, Merck. P. Dennis, Y. Huang: Employment: AZ. C. Wadsworth: Employment: AZ; Stock ownership: AZ. N. Rizvi: Consulting: AZ, Roche, Novartis, Merck, Pfizer, Lilly, AZ, BMS, Merck Stock ownership: Gritstone Oncology. All other authors have declared no conflicts of interest.

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