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E.F. Croft
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OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:O.T. Brustugun, S. Lu
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 2
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OA23.07 - Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (ID 3731)
14:20 - 15:50 | Author(s): E.F. Croft
- Abstract
- Presentation
Background:
In 2011, following gefitinib (IRESSA[®]) NDA voluntary withdrawal, US patients benefiting from gefitinib were eligible to continue gefitinib through the IRESSA Clinical Access Program (ICAP), an IRB-approved protocol. A subset of ICAP investigators subsequently collected additional retrospective data on their ICAP patients through another IRB-approved project (“chart-review subset”).
Methods:
For all enrolled ICAP patients, demographic and serious adverse event (SAE) reports were reviewed. All ICAP investigators were invited to participate in chart review; 47 accepted and collected data on patient/tumor characteristics and safety/tolerability of prolonged gefitinib therapy among their 79 ICAP patients.
Results:
Across 137 US sites, 191 patients enrolled in ICAP. As of September 2016, 75 (39%) remain on gefitinib; discontinuations were due to progression (36%), death (34%), AEs (13%), or other (17%). Sixty-four (34%) patients reported 162 SAEs; 5 (2.6%) patients had 12 SAEs considered to be gefitinib-related by investigators. The chart-review subset included 79 (41%) patients with median age of 69 years at ICAP enrollment, who were predominantly female (70%) and white (84%); 95% had a confirmed NSCLC diagnosis. Due to the evolving understanding of genetic mutations in NSCLC at the time of gefitinib initiation, the majority of patients (79%) never had EGFR sequencing performed. Although tissue is not available for EGFR status confirmation, we assume these patients are nearly exclusively EGFR mutation-positive. Median total length of gefitinib was 11.1 years (6.5-15.1; Table). Long-term gefitinib was well-tolerated; 5% discontinued due to a gefitinib-related AE. Ten-year survival rate from first-ever initiation of gefitinib was 86% and 15-year was 59%. Table. Gefitinib treatment patterns and tolerability among ICAP chart-review patients.Parameter n, % Observed Population (N=79) Total time on gefitinib, prior to and during ICAP Median duration, y, range 11.1 (6.5-15.1) Prior to ICAP Median duration, y, range 7.8 (5.4-10.9) Starting dose 250 mg/day 67 (84.8) No dose changes due to AEs 75 (94.9) During ICAP Median duration, y, range 3.5 (0.04-4.7) Dose: 250 mg/day 76 (96.2) Treatment-related AEs Grade 1-2 Grade ≥3 Grade unknown 13 (16.5) 1 (1.3) 2 (2.5) Dose reductions due to treatment-related AEs 1 (1.3) Discontinuations due to treatment-related AEs 4 (5.1) Discontinuations due to progressive disease 11 (28.9)
Conclusion:
The majority of this subset of patients who participated in ICAP based on long-term clinical benefit from gefitinib continue to do well with gefitinib, demonstrating good tolerance of therapy and survival for a median duration of more than 10 years.
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P3.02b - Poster Session with Presenters Present (ID 494)
- 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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P3.02b-077 - Osimertinib Expanded Access Program for Previously Treated Patients With Advanced EGFR T790M Mutation-Positive NSCLC (ID 4923)
14:30 - 15:45 | Author(s): E.F. Croft
- Abstract
Background:
The US AZD9291 Expanded Access Program (EAP) was conducted to provide compassionate access to osimertinib for previously treated patients with advanced/metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
Methods:
Patients (≥18 years old) with EGFR T790M mutation-positive NSCLC and a WHO Performance Status of 0–2 who had received ≥1 prior lines of therapy that included an EGFR tyrosine kinase inhibitor (TKI) or progressed during EGFR TKI treatment, were eligible. Patients received osimertinib at 80mg oral, once-daily, until dose reduction, discontinuation or EAP completion following FDA approval (November 2015). Patient demographics, T790M testing, safety and tolerability including serious adverse events (SAEs) were collected. Patient response was collected at investigator discretion, but not mandated by the EAP protocol. For required T790M diagnostics, various testing methods were permitted.
Results:
Osimertinib was provided to 248 EGFR T790M mutation-positive patients through the EAP (May 2015 to November 2015). Of the 244 patients with reported T790M method data, the majority were enrolled based on samples from tissue (n=187) and blood (n=48), whereas others were based on pleural fluid (n=5) or urine (n=4). Use of noninvasive (ie, liquid biopsy) T790M testing varied across the 25 participating sites: 5 sites (20%) enrolled no patients using liquid biopsy, 2 (8%) enrolled all patients based on liquid biopsy, and 18 (72%) enrolled based on different methods. Median age was 65 years old (range, 31–91), 69% of patients were female, and 85% of patients received ≥2 prior cancer treatments. Prior erlotinib therapy was reported in 96% of patients. Starting daily dose of 80mg osimertinib was maintained throughout the study in 238 patients (96%) and reduced to 40mg in 10 patients because of AEs/intolerance. Once commercially available, most patients (n=205; 83%) continued on osimertinib, thus completing the EAP. Reasons for EAP withdrawal prior to conversion included disease progression (7%) or death (5%). A total of 19 (8%) deaths were reported during the EAP, mostly attributed to lung cancer/disease progression and/or respiratory complications (n=16; 84%). Five (2%) patients reported drug-related SAEs, including dyspnea, deep vein thrombosis, femur fracture, increased alanine aminotransferase, and pneumonitis.
Conclusion:
In a real-world setting, US AZD9291 EAP demonstrated that osimertinib was well tolerated in previously treated patients with EGFR T790M mutation-positive NSCLC, and most converted to commercial therapy following FDA approval. This EAP suggests early uptake of non-invasive T790M testing at some centers.
