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G. Finocchiaro
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P1.06 - Poster Session with Presenters Present (ID 458)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.06-006 - Treatment beyond Progression in Patients with Advanced Squamous NSCLC Participating in the Expanded Access Programme (EAP) (ID 5450)
14:30 - 14:30 | Author(s): G. Finocchiaro
- Abstract
Background:
Response patterns of immunotherapies differ from those seen with other therapies approved for the treatment of tumors. Due to this reason, immunotherapy protocols generally allow patients (pts) to continue treatment beyond investigator-assessed radiographic progressive disease (PD) as long as there is ongoing clinical benefit, but to date no data has been reported regarding treatment beyond PD in routine clinical practice. Here we report the analysis about the subgroup of pts treated beyond initial PD in the italian cohort of nivolumab EAP for pts with squamous non small cell lung cancer (Sq-NSCLC).
Methods:
Nivolumab was available upon physician request for pts aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV 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 (AE) 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.
Results:
With a median follow-up of 5.2 months (range 0-12.9), 363 pts were evaluable for response. Prior to first progression, the objective response rate (ORR) was 14%, with 1 complete response (CR) and 50 (14%) partial responses (PR), and the disease control rate (DCR) was 41%. Sixty-six pts were treated beyond RECIST defined progression, with 23 pts obtaining a non-conventional benefit, meaning a subsequent tumor reduction or stabilization in tumor lesions. In particular, 17 pts obtained a SD and 6 pts obtained a PR. As to July 2016, median overall survival in these pts had not been reached (95% CI: 3.2-4.6) and 6 months and 12 months OS were 75% and 53%, respectively. The safety profile was consistent to what already observed in the general population.
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 reduction 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 treatment beyond progression.
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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-094 - Italian Nivolumab Advanced Squamous NSCLC Expanded Access Program: Efficacy and Safety in Patients with Brain Metastases (ID 5144)
14:30 - 14:30 | Author(s): G. Finocchiaro
- Abstract
Background:
The prognosis of NSCLC patients (pts) with brain metastases is still quite poor. These pts usually do not meet the inclusion criteria to be enrolled in clinical trials. Nivolumab Italian Expanded Access Program (EAP) allowed this subpopulation of pts to be included, providing the opportunity to evaluate safety and efficacy of nivolumab treatment in pts with brain metastases.
Methods:
upon physician written request, nivolumab was provided to pts who met the following inclusion criteria: aged ≥18 years, who had received a diagnosis of squamous NSCLC, and who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV squamous NSCLC. Nivolumab is administered intravenously at the dose of 3 mg/kg every 2 weeks for a maximum duration of 24 months. We describe efficacy and safety of nivolumab in pts who received at least one dose. Adverse events were monitored using Common Terminology Criteria for Adverse Events.
Results:
from our cohort of 372 patients diagnosed with squamous NSCLC, we report the results of 38 (10.2%) pts with treated and asymptomatic brain metastases. In these pts, with median follow-up of 4.5 months and median number of doses of 6 (range, 1–18), disease control rate was 47.3%, including 1 complete response, 6 partial responses and 11 stable diseases. Treatment beyond RECIST defined progression was allowed, under protocol defined circumstances, in 4 pts. Median progression-free survival was 5.5 months, and overall survival was 6.5 months (data lock of April 2016). Out of the 38 pts included, only 1 discontinued treatment due to AE (2.6%), whereas 21 pts (55.3%) discontinued treatment for non-toxicity related reasons.
Conclusion:
although preliminary, these results demonstrate efficacy of nivolumab in squamous NSCLC pts with brain metastases. Safety of nivolumab in these pts is consistent with previously reported data from clinical trials. These results suggest nivolumab could be beneficial in this subpopulation of pts with unfavourable prognosis.
