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Glen J Weiss



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    P2.04 - Immuno-oncology (ID 167)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.04-60 - Pembrolizumab-Based Regimens Administered at Non-Standard Frequency in Non-Small Cell Lung Cancer (NSCLC) (ID 1463)

      10:15 - 18:15  |  Author(s): Glen J Weiss

      • Abstract
      • Slides

      Background

      Pembrolizumab (P) administered every 3 weeks ± chemotherapy is a standard treatment option for advanced NSCLC. However, other than modeling and simulation-based analysis, there have been no post-approval studies to determine the optimal administration frequency or if longer intervals between administrations are effective.

      Method

      We retrospectively reviewed medical charts of 81 patients with advanced NSCLC treated with P for at least 4 cycles at a single academic center (02/2016-3/2019). 2 patients groups were selected: those who received 3 or more P-based regimens at non-standard frequency intervals between cycles longer than 3 weeks ± 3 days (group A), or those who received P-based regimens at standard frequency or up to 2 non-standard cycles (group B). Descriptive tables of demographic details, tumor characteristics, treatment details, and immune-related adverse events (irAEs) were generated. Kaplan-Meier survival analysis and Cox proportional hazards model for multivariable regression analysis were utilized.

      Result

      Of 81 P-treated patients, 47 (58%) had received at least 4 cycles (group A: 14, B: 33). There were no significant differences between groups in sex, stage at diagnosis, smoking status, driver oncogene mutations, PD-L1 expression, tumor mutation burden, line of therapy, performance status or grade 3 irAEs. Patients in group B were more likely to receive P + chemotherapy (group A: 0%, B: 33.3%, p = 0.02). Patients in group A were more likely to have any grade irAEs (groups A: 78.6%, B: 33.3%, p = 0.024). The reasons for any non-standard cycles in group A were: irAEs (14.3% patients), non-irAE medical issues (35.7% patients) and solely non-medical patient-physician preference (50% patients). Median time to treatment discontinuation (TTD) was significantly longer in group A than group B (24 months vs 5 months, p <0.0001), as was median overall survival (OS) (Not reached vs 14 months, p=0.0029). Patients in group A continued to show significantly longer overall survival when adjusted for confounding variables (Hazard Ratio 5.6, p=0.029).

      Conclusion

      Our data, though limited by sample size and single institution design, shows that a significant proportion of patients receive P at extended intervals in routine clinical practice and with no worse outcomes than would be expected for those with advanced NSCLC receiving P at label-specified 3-week intervals. Given the durability of benefit seen in such patients, this requires confirmation in larger datasets and prospective trials so as to maximize patient experience and clinical outcomes while minimizing financial toxicity.

      Group A

      (≥ 3 Non-standard cycles)

      Group B

      (Standard or ≤ 2 non-standard cycles)

      p-value

      (chi-square

      log-rank test)

      N = 14 N = 33
      Median OS, months (95% CI) Not reached (14 - not reached) 14 (8 - not reached) 0.0029
      Median TTD, months (95% CI) 24 (17 - not reached) 5 (4-6) <0.0001

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