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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
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): P. Bidoli
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.
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.
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.
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
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
P1.01-053 - Italian Nivolumab Expanded Access Programme (EAP): Data from Patients with Advanced Non-Squamous NSCLC and Brain Metastases (ID 10056)
09:30 - 16:00 | Author(s): P. Bidoli
Among patients (pts) affected by non-squamous non-small cell lung cancer (non-Sq-NSCLC), those with secondary brain metastases are very common and are characterized by a poor prognosis. As they are usually excluded from clinical trials, the EAP offered an opportunity to evaluate nivolumab efficacy and safety in these patients outside of a controlled clinical trial in Italy.
Nivolumab was available upon physician request for pts aged ≥18 years with a diagnosis of non-Sq-NSCLC 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 to a maximum of 24 months. Pts included in the analysis had received ≥ 1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events. Pts with brain metastasis were eligible if asymptomatic, neurologically stable and either off corticosteroids or on a stable dose or decreasing dose of ≤ 10 mg daily prednisone.
Out of 1588 patients with non-Sq-NSCLC participating in the EAP in Italy, 409 (26%) had asymptomatic and controlled secondary brain metastases. Pts received a median number of 7 doses (1-45) and had a median follow-up of 6.1 months (0.1-21.9). The disease control rate was 40%, including 3 pts with a complete response, 65 pts with a partial response and 96 with stable disease. Among these pts, 118 were receiving steroid therapy at baseline and 74 received concomitant radiotherapy. As of March 2017, median overall survival of this subpopulation was 8.1 months (6.2-10.1). Overall, among pts with brain metastasis, 337 discontinued treatment for any reason, with only 23 (7%) pts who discontinued treatment due to adverse events, in line with what observed in the general population and in previous studies.
These data confirmed the activity of nivolumab in patients with non-Sq-NSCLC and brain metastases, supporting the use of nivolumab in this population with poor prognosis. Moreover, as already observed in other tumor types, safety results were consistent to what already reported and confirmed the favorable safety profile.