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C. Lai



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    P2.03b - Poster Session with Presenters Present (ID 465)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03b-014 - Atezolizumab in Advanced NSCLC Patients with Baseline Brain Metastases: A Pooled Cohort Safety Analysis (ID 5214)

      14:30 - 14:30  |  Author(s): C. Lai

      • Abstract

      Background:
      Brain metastases, occurring in 20% to 40% of patients with advanced NSCLC, are associated with poor survival. Atezolizumab (anti-PDL1) inhibits PD-L1/PD-1 signaling and restores tumor-specific T-cell immunity. Clinical benefits have been observed in patients with NSCLC across PD-L1 expression levels following atezolizumab monotherapy, but the safety profile in NSCLC patients with brain metastases has not previously been explored.

      Methods:
      Pooled safety analyses were conducted in 843 patients who received atezolizumab as 2L+ treatment in 4 studies (PCD4989g: NCT01375842 [N = 76]; BIRCH: NCT02031458 [N = 520]; FIR: NCT01846416 [N = 105]; POPLAR: NCT01903993 [N = 142]). Patients had asymptomatic untreated brain metastases or stable previously treated brain metastases at baseline.

      Results:
      27 (3%) of 843 patients in the pooled cohort had baseline brain metastases; 23 of whom were previously treated with radiation to the brain. Among the 27 patients, mean age was 60 years, 41% were male, 85% had non-squamous NSCLC, and 70% had received 3L+ therapy. Median number of atezolizumab cycles (21d/cycle) was 4 (range, 1-39). Neurological AEs occurred in 12 (44%) patients with and 229 (28%) patients without baseline brain metastases (Table). The incidence of treatment-related neurological AEs was 4 (15%) in patients with and 77 (9%) in patients without baseline brain metastases, including the most common treatment-related AE of headache in 2 (7%) and 27 (3%) patients, respectively. The most common all-cause AEs in patients with baseline brain metastases were fatigue, nausea, and vomiting (7 [26%] each); 3 (11%) patients developed new brain lesions on study, none during treatment. No treatment discontinuations occurred due to AEs.

      Conclusion:
      The current analyses indicate that atezolizumab has an acceptable safety profile in patients with NSCLC who have asymptomatic or previously treated stable brain metastases. Further investigation is needed to fully assess the efficacy of atezolizumab in this patient population.

      Summary of safety data in patients with advanced NSCLC with and without baseline brain metastases following atezolizumab as 2L+ treatment
      Pooled Cohort (N = 843)
      Patients Without Baseline Brain Metastases (n = 816) n (%) Patients With Baseline Brain Metastases (n = 27) n (%)
      Any AE 779 (96%) 26 (96%)
      Any neurological AE 229 (28%) 12 (44%)
      Treatment-related AEs 548 (67%) 16 (59%)
      Treatment-related neurological AEs 77 (9%) 4 (15%)
      Serious AE 311 (38%) 9 (33%)
      Serious neurological AEs 21 (3%) 1 (4%)
      Treatment-related SAEs 78 (10%) 1 (4%)
      Discontinued treatment due to AE 47 (6%) 0 (0%)