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J. Corral
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-015 - Clinical-Pathological and Survival Analysis of Patients with Advanced NSCLC and EGFR Mutation Treated With a Drug Therapy Anti-T790M (ID 2324)
09:30 - 09:30 | Author(s): J. Corral
- Abstract
Background:
Multiple phase III trials have demonstrated the benefit in terms of RR and PFS of the EGFR TKIs versus platinum-based chemotherapy in patients with advanced NSCLC and EGFR mutation. Median PFS of these patients ranges from 9-13 months, time where a new therapy approach is needed, the most commonly chemotherapy nowadays. The main resistance mechanism described in this clinical situation is the development of T790M resistance mutation. There are no comparative efficacy data among chemotherapy and T790M targeted therapies. Our research included data from 15 patients treated in our Institution Phase I Unit with a T790M inhibitor analyzing the effectiveness according to their clinical features and mutational profile (T790M carriers or not)
Methods:
Descriptive clinico-pathological and efficacy analysis from October 2013 to March 2015 of patients with advanced NSCLC and EGFR mutation in progression and receiving T790M targeted therapy in the context of a phase I clinical trial performed in our Clinica Trial Unit.
Results:
Fifteen patients were included. The median age resulted 60 years (range 37-80 years) with a proportion of 8 (55%)/7 (45%) female/men. The entire study population was Caucasian and had an histological diagnosis of stage IV NSCLC with the presence of activating mutation of EGFR (66% L848R and del19 44%). In relation to smoking exposition, most of the patients were past-smokers (55%) or active (13%). All patients received a specific T790M inhibitor, 7 of them (45%) with a confirmed T790M mutation by local and/or local analysis. The average of prior lines of therapy before the experimental T790M inhibitor was 1,9. No grade 3/4 toxicities were reported. After an average follow up of 17 months, PFS of the overall population was 4,73 months, with a statistically significance difference between T790M positive patients (8,14 months) versus negative or unknown (1,8 months). We have no outcome at present of the OS for the active treatment of most the patients.
Conclusion:
Despite the limitation of the number of patients and follow-up time, our research suggested a clear survival benefit with the T790M inhibitor in the context of advanced NSCLC patients harboring T790M resistance mutation versus non in progression after EGFR TKI first line therapy.
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P1.01-064 - A Phase II Study of Gemcitabine-Cisplatin plus Necitumumab for Stage IV Sq-NSCLC (ID 927)
09:30 - 09:30 | Author(s): J. Corral
- Abstract
Background:
To report the efficacy and safety results from a study of necitumumab (N), manufactured under process D, modified from Process C, used in the pivotal SQUIRE study, in combination with gemcitabine (G) plus cisplatin (C) as first-line treatment in patients with advanced squamous non-small cell lung cancer (Sq-NSCLC). (NCT01788566)
Methods:
This was an open-label, single-arm, multicenter, phase II study in patients with advanced Sq-NSCLC. Patients were enrolled who were aged ≥18 years and had measurable, pathologically confirmed stage IV Sq-NSCLC without prior chemotherapy. Patients had ECOG-PS 0-1, adequate organ function, and life expectancy of ≥12 weeks. Patients received N (800 mg iv, Days 1 and 8) plus GC (G=1250 mg/m² iv, Days 1 and 8; C=75 mg/m² iv, Day 1) each 3-week cycle for up to 6 cycles. Patients with at least stable disease (SD) could continue to receive N alone until progressive disease (PD) or other discontinuation criteria. Primary endpoint was objective response rate (ORR) based on RECIST1.1. Secondary endpoints included overall survival (OS), progression-free survival (PFS), disease control rate (DCR), change in tumor size (CTS; % improvement in lesions), and safety.
Results:
Patients (N=61), median age 65 years, heavy metastatic disease burden; approximately 70% of the patients had metastases to ≥ 2 organ systems. Efficacy results, including an ORR of 48.1% are shown in the Table. Survival and PFS findings were similar to those reported in the SQUIRE study in the GC+N arm (SQUIRE results: median OS of 11.5 months, 1-year survival rate of 47.7%, and median PFS of 5.7 months). Median duration of treatment was 12 weeks (4 cycles) for G and C and 16 weeks (5 cycles) for N; the median relative dose intensity was 85% for G and 93% for C and N. Twenty-eight (46%) patients continued on single-agent N (median: 4 cycles). Skin reactions (n=49; 80.3%) and hypomagnesemia (n=21; 34.4%) were the most commonly reported adverse events of special interest (AESIs, all grades). AESI ≥ Grade 3 were skin reactions (n=8; 13.1%), thromboembolic events (n=7; 11.5%), hypomagnesemia (n=6; 9.8%), and hypersensitivity/ IRR (n=3; 4.9%). There were 27 deaths (20 due to PD and 7 due to AEs [5 had no causal relationship to study drug]) at the time of data cut-off.Table. Efficacy Results
N=61 ORR*† (CR+PR), n (%) [95% CI] 26/54 (48.1)† [34.34–62.16] CR 0 PR, n (%) 26/54 (48.1)† SD 18 (29.5) PD 9 (14.8) Not evaluable 1 (1.6) Not assessable 7 (11.5) DCR CR+PR+SD, n (%) [95% CI] 44 (81.5)† [68.57–90.75] Median OS, months (95% CI) 11.7 [7.59–NA] 1-year survival rate, % (95% CI) 47.6% [30.20–63.08] Median PFS, months (95% CI) 5.6 [3.68–6.87] Median CTS, (%) 42.1 *Assessed by investigators †Patients who had a post-baseline radiological assessment, n=54
Conclusion:
The efficacy results and the safety profile, with N manufactured under process D, are consistent with what is expected for this combination as first-line therapy of patients with metastatic Sq-NSCLC.
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-002 - Immunotherapy as an Effective Treatment Option in the Metastatic NSCLC in Spite of PD-1 or PDL-1 Inhibition and Line of Therapy (ID 2275)
09:30 - 09:30 | Author(s): J. Corral
- Abstract
Background:
Lung cancer is the leading cause of cancer death globally. Important survival benefit has been recently obtained with targeted therapies against driver mutations. Immunotherapy approach under development will probably represent a new standard option of care in pretreated patients: clinical and/or pathological prognostic factors will further be needed to select the maximum benefit treated population.
Methods:
We reviewed retrospectively clinical, pathological and efficacy data from 28 patients with metastatic NSCLC treated with anti-PD1 (programmed cell death 1) and anti-PDL1 (programmed cell death-ligand 1) check-point inhibitors in our Institution between 2013 and 2015.
Results:
28 metastatic NSCLC patients were treated: 2 (7,14%) in first line, 14 (50%) in second line and 12 (40%) patients beyond third line. 82% were males, median age was 61 years old, and 71,4% adenocarcinomas. Mutation profile was defined as 1 patient (3,5%) EGFR positive and 1 patient ROS-1 positive (3,5%). PDL-1 resulted positive by immunohistochemistry on 43% of total population. 75% of patients received anti-PDL-1 therapy versus 25% anti-PD1 check point inhibitors. With a median follow up time of 22 months, overall response rate (ORR) was 10,7% and disease control rate (DCR) was 64,3%: no differences were seen by immunotherapy strategy. ORR, DCR, and median time for treatment (MTT) were analysed according to the line of therapy and type of immunotherapy. ORR 0%, DCR 100% and MTT 104 days at first line setting; ORR 7,14%, DCR 64,28% and MTT 98 days at second line; and finally, ORR 18,18%, DCR 63,63% and MTT 67 days at third line or beyond. Most of patients remain on treatment so survival data were not reached. The most common grade III-IV adverse events related with treatment were pneumonitis (14,3%), fatigue (3,6%), hyperamylasemia (3,6%), hypertransaminasemia (3,6%) and neurologic disorders (7%).
Conclusion:
Our retrospective and local analysis confirmed immunotherapy as a safe and effective therapy option with high rate of DCR and longer MTT than standard chemotherapy, independently PD-1 or PDL-1 inhibition or line of therapy used.
