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R. Bordoni



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    OA 17 - Immunotherapy II (ID 683)

    • Event: WCLC 2017
    • Type: Oral
    • Track: Immunology and Immunotherapy
    • Presentations: 1
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      OA 17.07 - Long-Term Survival in Atezolizumab-Treated Patients with 2L+ NSCLC from Ph III Randomized OAK Study (ID 8663)

      14:30 - 16:15  |  Author(s): R. Bordoni

      • Abstract
      • Presentation
      • Slides

      Background:
      Atezolizumab (anti–PD-L1) inhibits PD-L1 binding to PD-1 and B7.1, restoring anti-cancer immunity. OAK, a Phase III study of atezolizumab vs docetaxel demonstrated superior OS of atezolizumab. The characteristics of the long-term survivors (LTS) in the OAK primary population (n = 850) are evaluated and describe the largest cohort of cancer immunotherapy-treated NSCLC LTS yet reported.

      Method:
      Patients received IV q3w atezolizumab (1200 mg) until PD / loss of clinical benefit or docetaxel (75 mg/m[2]) until PD / unacceptable toxicity. No crossover was allowed. LTS were defined as patients with OS ≥ 24 months and non-LTS as those who died within 24 months of randomization. Patients with OS censored prior to 24 months were not included. Data cutoff, January 23, 2017.

      Result:
      A higher 2-year survival rate was observed for the atezolizumab-arm (31%) vs docetaxel-arm (21%). After a minimum follow-up of 26 months, there were 119 LTS vs 279 non-LTS in the atezolizumab-arm and 77 LTS vs 299 non-LTS in the docetaxel-arm. Characteristics of atezolizumab-arm LTS and non-LTS are shown (Table). Atezolizumab-arm LTS were enriched for non-squamous histology and high PD-L1–expressing tumors, but also included low/no PD-L1–expressing tumors (40.3%). Atezolizumab-arm LTS had higher ORR (39.5%) than non-LTS (5.0%) but included LTS subjects with PD. 52.9% atezolizumab-arm vs 71.4% docetaxel-arm LTS received anti-cancer non-protocol therapy (NPT) after discontinuation of protocol-defined therapy. 51.9% of docetaxel-arm LTS vs 12.7% non-LTS received non-protocol immunotherapy. Median treatment exposure in atezolizumab-arm LTS was 18.0 months. Atezolizumab-arm LTS had a comparable safety profile to all atezolizumab-treated population.

      Conclusion:
      Atezolizumab provides superior 2-year OS benefit vs docetaxel and is well tolerated. The majority of docetaxel-arm LTS received a checkpoint inhibitor as NPT. Atezolizumab LTS appeared to have favorable prognostic factors, including non-squamous histology, but notably were not limited to patients with RECIST v1.1 response or with PD-L1 expression.

      Table. Characteristics of Atezolizumab-Arm Long-Term Survivors (LTS) vs Non-Long Term Survivors (Non-LTS)
      Atezolizumab LTS (n = 119) n (%) Atezolizumab Non-LTS (n = 279) n (%)
      Sex
      Male 61 (51.3) 183 (65.6)
      Female 58 (48.7) 96 (34.4)
      Tobacco use history
      Never smoker 29 (24.4) 47 (16.8)
      Current/previous smoker 90 (75.6) 232 (83.2)
      Histology
      Non-squamous 101 (84.9) 195 (69.9)
      Squamous 18 (15.1) 84 (30.1)
      No. of prior therapies, 1 89 (74.8) 209 (74.9)
      ECOG performance status at baseline
      0 60 (50.4) 89 (31.9)
      1 59 (49.6) 190 (68.1)
      EGFR mutation status, positive 11 (9.2) 26 (9.3)
      PD-L1 IHC subgroup
      TC3 or IC3 28 (23.5) 39 (14.0)
      TC1/2/3 or IC1/2/3 71 (59.7) 156 (55.9)
      TC0 and IC0 48 (40.3) 119 (42.7)
      Best overall response
      Complete response 5 (4.2) 0 (0)
      Partial response 42 (35.3) 14 (5.0)
      Stable disease 47 (39.5) 97 (34.8)
      Progressive disease 25 (21.0) 142 (50.9)
      IC, tumor-infiltrating immune cell; TC, tumor cell. TC3 or IC3 = PD-L1 ≥ 50% TC or 10% IC; TC1/2/3 or IC1/2/3 = PD-L1 ≥ 1% on TC or IC; TC0 and IC0 = PD-L1 < 1% on TC and IC. NCT02008227.


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