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R.J. Kelly
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-021 - Efficacy and Safety of ASP8273 versus Erlotinib or Gefitinib as First-Line Treatment in Subjects with EGFR<Sup>Mut+</Sup> NSCLC (ID 4148)
14:30 - 15:45 | Author(s): R.J. Kelly
- Abstract
Background:
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) have shown antitumor efficacy and prolonged progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) harboring EGFR activation mutations; however, acquired resistance often develops limiting clinical efficacy. ASP8273 is an irreversible, once-daily (QD), orally available TKI with activity against both activating and resistance EGFR mutations (ex19del, L858R, T790M). Preliminary findings from Phase 1 and Phase 2 trials in the US, Japan, Taiwan, and Korea have demonstrated antitumor activity and overall tolerability of ASP8273 at doses of 100mg–300mg.
Methods:
This global, multicenter, open-label, randomized, Phase 3 study will enroll ~600 adult subjects with Stage IIIB/IV NSCLC with EGFR-activating mutations (ex19del or L858R, with or without T790M) who have not been treated with an EGFR inhibitor TKI (NCT02588261). Subjects will be randomized 1:1 to treatment with either 300mg oral ASP8273 QD or erlotinib/gefitinib. Each site will select a comparator drug (150mg erlotinib QD or 250mg gefitinib QD) at the beginning of the study. Randomization will be stratified by ECOG status (0, 1, and 2), EGFR mutation (ex19del, L858R), comparator selected (erlotinib vs gefitinib), and race (Asian vs non-Asian). Subjects will not be enrolled if they harbor both ex19del and L858R. All subjects will begin treatment on Day 1 Cycle 1 and will continue on 28-day continuous dosing cycles until the subject discontinues (eg, due to radiologic progression as determined by RECIST or unacceptable toxicity). Dose reductions will be allowed for ASP8273 and erlotinib, but not for gefitinib. The primary study objective is PFS as assessed by independent radiological review (IRR); secondary study objectives are overall survival, best overall response rate, disease control rate and duration of response by IRR, safety/tolerability, and patient quality of life. An independent Data Monitoring Committee will oversee trial safety and the interim futility analysis. Enrollment for the trial began 26 February 2016; 46 subjects have been randomized as of 17 May 2016.
Results:
Section not applicable
Conclusion:
Section not applicable
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P3.07 - Poster Session with Presenters Present (ID 493)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Regional Aspects/Health Policy/Public Health
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-002 - Complications and Costs of Diagnostic and Post-Progression Biopsies among Patients with Non-Small Cell Lung Cancer (NSCLC) (ID 4762)
14:30 - 15:45 | Author(s): R.J. Kelly
- Abstract
Background:
With an increase in biomarker-directed therapies, tissue biopsy to identify targetable mutation status will become a mainstay of managing patients with NSCLC. The current study assessed the frequency, complications and costs of initial diagnostic biopsy (IDP) and post-progression biopsy (PPB) given the current limited information.
Methods:
This retrospective, observational study was conducted using administrative claims data from over 30 million commercially insured individuals in the US (2006-2014). Patients with continuous health-plan enrollment ≥12-months prior and ≥3-months post-index (first-observed) NSCLC diagnosis date were included and followed until health-plan disenrollment, study endpoint (December 2014) or death (whichever occurred earlier). Patients with NSCLC (n=20,013) were categorized into 4 groups (IDB only (58%); IDB+PPB (9%); PPB only (1%); and no biopsy (32%)) based on presence or absence of claim(s) for IDB and/or PPB. Biopsy procedures, post-biopsy complications and costs were assessed during the follow-up period. Identification of claims was based on ICD-9-CM diagnosis/procedure and/or HCPCS codes. All analyses were descriptive in nature.
Results:
Study included 20,013 patients (median age: 69 years) with 52% being females, 73% enrolled in a preferred provider organization and 35% managed in Midwest. 10% of the patients had a PPB. Bronchoscopy (IDB 53%; PPB 71%) and percutaneous needle biopsy (IDB 42%; PPB 21%) were the commonly employed biopsy procedures. 63% patients had a medical claim for at least 1-complication within 30-days post IDB for difficulty breathing (41%), severe chest pain (23%) or pneumothorax (14%). 30-day complication rate (61%) was similar among patients with a PPB. Among patients undergoing bronchoscopy higher proportion had medical claim for complications including difficulty breathing (IDB: 44% vs. 37%; PPB: 46% vs. 26%) and hemoptysis (IDB: 14% vs. 4%; PPB: 15% vs. 3%) compared with patients undergoing percutaneous needle biopsy. Average IDB episode costs were significantly higher among patients with a complication compared with patients without a complication (day of biopsy: $12,030 vs. $6,508; within 7-days: $13,657 vs. $7,765; p-value<0.001).
Conclusion:
In this large cohort of NSCLC patients the rate of PPB was 10%. Importantly, for the first time we determined that the rates of complications were similar for the IDB and PPB among patients enrolled in a large national US health plan. With likely increased demands by patients, providers and payers for diagnostics confirmation for biomarker-directed therapies, data from this study will be of value in comparing complications rate and determining budget-impact of newer less-invasive molecular testing methods.
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SC29 - Access, Value Assessments and Affordability of Novel Therapies (ID 353)
- Event: WCLC 2016
- Type: Science Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:M. Krzakowski, E. Richardet
- Coordinates: 12/07/2016, 11:00 - 12:30, Strauss 1
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SC29.02 - Value-Based Assessments in Lung Cancer Therapy: The North American Perspective (ID 6722)
11:00 - 12:30 | Author(s): R.J. Kelly
- Abstract
- Presentation
Abstract not provided
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