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P1.01 - Advanced NSCLC (ID 757)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- 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): F. Piantedosi
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.
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): F. Piantedosi
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).
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.
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.
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.