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E. Ricevuto



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    MA 02 - Emerging Targets (ID 656)

    • Event: WCLC 2017
    • Type: Mini Oral
    • Track: Clinical Design, Statistics and Clinical Trials
    • Presentations: 1
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      MA 02.05 - Nivolumab in Advanced Non-Squamous NSCLC Patients with KRAS Mutations: Results from the Italian Expanded Access Program (EAP) (ID 9608)

      11:00 - 12:30  |  Author(s): E. Ricevuto

      • Abstract
      • Presentation
      • Slides

      Background:
      Nivolumab significantly improved overall survival (OS) versus docetaxel in patients (pts) with previously treated non-squamous non small cell lung cancer (non-Sq-NSCLC) in the Checkmate 057 study. In a pre-specified subgroup analysis of this trial, this advantage was confirmed also in patients (pts) with KRAS-mutation (KRAS+). However, since the number of KRAS+ pts enrolled in the trial was too small to draw definitive conclusions, the Italian nivolumab expanded access program (EAP) for non-Sq-NSCLC might represent an important source of information about this subpopulation. Here we report the results of the use of nivolumab in pts with KRAS mutation treated in the Italian EAP.

      Method:
      Nivolumab was provided upon physicians’ request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Pts included in the analysis received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events.

      Result:
      Overall, 1588 pts with advanced non-Sq-NSCLC, enrolled in 168 sites, received at least one dose of nivolumab in the Italian EAP. Among 532 pts evaluated for KRAS mutation, 206 (39%) resulted positive. In this subgroup of pts, the best overall response rate (BORR) was 20%, including 2 pts with complete response and 39 pts with partial response. The median OS was 10.7 months (8.6-12.8), with a median follow-up of 7.7 months (0.1-21.2) and a median number of 8 doses (1-45). These results were in line with those ones showed in the overall population (18% BORR and 11 months median OS, respectively). Overall, among pts with KRAS mutation, 166 discontinued treatment for any reason, with only 14 (8%) pts who discontinued treatment due to adverse events, in line with what observed in the general population and in previous studies.

      Conclusion:
      To date, no direct targeted therapy is available for pts with KRAS mutation. This analysis seems to confirm, in a real word setting and in a larger number of pts, the results obtained with nivolumab in KRAS-positive pts in CheckMate 057, thus representing a potentially effective therapeutic option for this subpopulation.

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    P1.01 - Advanced NSCLC (ID 757)

    • Event: WCLC 2017
    • Type: Poster Session with Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.01-065 - Treatment Beyond Progression with Nivolumab in Patients with Advanced Non-Squamous NSCLC: Results from the Italian Expanded Access Program (ID 9333)

      09:30 - 16:00  |  Author(s): E. Ricevuto

      • Abstract

      Background:
      Because of the novel mechanism of action of immunotherapies like nivolumab, response patterns may differ from other therapies and may provide a rationale for considering treatment beyond progression. Immunotherapy protocols generally allow patients (pts) to continue treatment beyond investigator-assessed progressive disease (PD) as long as there is ongoing clinical benefit. Here we report the analysis of pts treated beyond PD in the Italian nivolumab EAP for pts with non-squamous non small cell lung cancer (Non-Sq-NSCLC).

      Method:
      Nivolumab was provided upon physicians’ request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV non-Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Pts included in the analysis received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events. Patients were allowed to continue treatment beyond initial PD as long as they met the following criteria: investigator-assessed clinical benefit, absence of rapid PD, tolerance of program drug, stable performance status and no delay of an imminent intervention to prevent serious complications of PD.

      Result:
      In total, 1588 Italian pts with advanced Non-Sq-NSCLC received at least one dose of nivolumab in the EAP across 168 sites and 1056 (66%) had PD. Of those, 274 pts (26%) were treated beyond progression. Before being treated beyond PD, the disease control rates (DCR) was 28%, with 1 complete response (CR), 27 partial responses (PR) and 49 stable diseases (SD). Post PD, 58 of all pts treated beyond PD achieved a non-conventional benefit, meaning a subsequent tumor reduction or stabilization in tumor lesions. With a median follow-up of 10.3 months (0.1-21.9) and a median of 11 (4-44) doses, median overall survival for pts treated beyond PD was 15.5 months (range: 13.1-17.9). Overall, among pts treated beyond PD, 200 discontinued treatment for any reason, with only 11 (5.5%) pts who discontinued treatment due to adverse events, suggesting no increased safety signals.

      Conclusion:
      As already observed in clinical trials, these preliminary EAP data seem to confirm that a proportion of pts who continued treatment beyond PD demonstrated sustained reductions or stabilization of tumor burden, with an acceptable safety profile. Further investigations are warranted in order to better define and identify pts who can benefit from this treatment strategy.