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H. Josè Soto Parra
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-092 - Nivolumab in Multi-Treated Patients with Advanced Sq-NSCLC: Data from the Italian Cohort of Expanded Access Programme (EAP) (ID 4792)
14:30 - 14:30 | Author(s): H. Josè Soto Parra
- Abstract
Background:
The prognosis of patients with advanced Sq-NSCLC worsens with the increase of the number of treatment linesand no effective therapeutic options were available for those refractory patients so far.Nivolumab demonstrated significant benefits against the SoC docetaxel in 2[nd] line treatment of advanced sq-NSCLC. In the real life experience of the EAP we could assess the clinical activity and tolerability of nivolumab not only in patients treated in 2[nd] line but also in patients who had received at least 2 lines of therapy prior than nivolumab.
Methods:
Nivolumab was provided upon physician request for patients aged ≥18 years who had relapsed after a minimum of 1 prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Pts included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (version 4.03).
Results:
210 patients, corresponding to 56.4% of the entire Italian cohort (n=372), received nivolumab after at least 2 prior lines of chemotherapy in the EAP: 120 (57.1%), 69 (32.9%) and 21 (10%) had received 2, 3 and > 3 prior lines of therapy, respectively. Response was evaluable in 204 patients: with a median number of 8 doses (range, 1–24) and a median follow-up of 5.1 months, the disease control rate was 47%, with 3 patients (1%) in complete response, 30 patients (14%) in partial response and 66 patients (32%) in stable disease. 36 patients (17%) were treated beyond RECIST-defined progression, with 11 of them achieving disease control. As of April 2016, median progression-free survival and median overall survival were respectively 3.8 and 11.2 months. 117/210 patients (55.7%) discontinued treatment for any reason except toxicity; 11 out of 210 (5.2%) discontinued due to AEs.
Conclusion:
These findings showed that nivolumab provided clinical activity with a manageable safety profile in patients with advanced, refractory Sq-NSCLC. These data suggest that nivolumab can be a treatment option for patients failing more than one line of chemotherapy.
