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S. Sakaki
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-035 - Correlation Between Immune-Related Adverse Events and Efficacy in Non-Small Cell Lung Cancer Treated with Nivolumab (ID 9403)
09:30 - 09:30 | Author(s): S. Sakaki
- Abstract
Background:
Nivolumab has been established as a novel standard of care in patients with pre-treated non-small-cell lung cancer (NSCLC). Patients treated with nivolumab sometimes experience its unique adverse events, called immune-related Adverse Events (irAEs). Given the mechanisms of action of immune-checkpoint inhibitors (ICIs), occurrence of irAEs may potentially reflect antitumor response. Here, we report the clinical correlation between irAE and efficacy in NSCLC patients treated with nivolumab.
Method:
Between Dec 2015 and Feb 2017, 38 advanced NSCLC patients were treated with nivolumab at our institution. All patients were enrolled in our single-institutional observational cohort study (UMIN000024414). We divided the patients into two groups: irAEs group and no-irAEs group and evaluated the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). Efficacy was assessed by RECIST version 1.1, and toxicity was graded based on CTCAE version 4.0.
Result:
Of thirty-eight, median age was 68.5 (range, 49 to 86), 74% was male, 68% was non-squamous cell carcinoma, and 82% was performance status of 0-1. Among overall population, ORR was 23.7%, and median PFS was 91 days. Eleven patients (29%) experienced irAEs and median time to onset irAEs was 53 days (range, 14 to 213 days). There was no significant correlation observed between PD-L1 expression on tumor and occurrence of irAEs. Most common irAE was pneumonitis (n = 5) and others were hypothyroidism (n = 4), hyperthyroidism, hypopituitarism, hepatitis, rash and elevated thyroid stimulating hormone (one, each). Patients with irAEs had significantly higher efficacy compared with those without (ORR: 63.6% versus 7.4%, p < 0.01 (Fisher’s exact test), mPFS: not reached (NR) versus 49 days, p < 0.01 (log-rank test). Landmark analysis in patients who achieved progression free ≥ 12 weeks showed a similar trend (p = 0.07). Next, we performed additional analyses on correlation with specific irAEs. Patients with pneumonitis and those without demonstrated similar outcome (p = 0.95 (log-rank test)). With regard to endocrine irAEs, the similar result was also observed (p = 0.95 (log-rank test)).
Conclusion:
In our study, there was a correlation between irAEs and efficacy in NSCLC patients treated with nivolumab. Occurrence of specific irAE was not necessarily associated the efficacy.
