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L.C. Roisman
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-047 - The Clinical Impact of Multiplex ctDNA Gene Analysis in Lung Cancer (ID 5758)
14:30 - 14:30 | Author(s): L.C. Roisman
- Abstract
Background:
Next-generation sequencing (NGS) of cell-free circulating tumor DNA (ctDNA) enables a non-invasive option for comprehensive genomic analysis of lung cancer patients. Currently there is insufficient data in regard to the impact of ctDNA analysis on clinical decision making. In this study, we evaluated the clinical utility of ctDNA sequencing on treatment strategy and progression-free survival.
Methods:
In this retrospective study, data was collected from files of 90 NSCLC patients monitored between the years 2011-2016 at the Thoracic Center Unit at Davidoff Cancer Center, Rabin Medical Center, Israel. The patients performed liquid biopsy NGS analysis by a commercial test (Guardant 360), in which ctDNA was extracted from plasma and analyzed by massively parallel paired end synthesis by digital NGS. This test allows the detection of somatic alterations such as point mutations, indels, fusions and copy number amplifications.
Results:
Age at diagnosis ranged between 31 and 89 years, with median age of 63 years. Sex ratio was 1:2.2. Out of 90 patients, 38 consecutive patient files have already been reviewed for clinical impact. 82% (31/38) were diagnosed with Adenocarcinoma. 5% (2/38) performed ctDNA at initial diagnosis, 48% (17/38) performed ctDNA after 1[st] line therapy due to progressive disease and the remaining 50% performed the test after multiple lines of treatment. Liquid biopsy NGS analysis allowed the detection of actionable mutations, according to NCCN guidelines, in 68% (26/38). Treatment decision was changed subsequent to NGS analysis in 34% (13/38) which received tailored targeted therapy. Interestingly, 13% (5/38) were detected with EGFR activating mutation following wild type result by standard local molecular testing based on RT-PCR from tissue biopsy. Based on the RECIST criteria of response evaluation, 30% of the patients had partial response after switching to targeted therapy, 15% had stable disease, 15% experienced progressive disease and ~40% were not evaluated yet. Survival rates will be calculated further in the study based on data availability.
Conclusion:
Our interim results analysis showed that liquid biopsy ctDNA testing revealed possible treatment options for more than two-thirds of patients analyzed, including FDA-approved drugs as well as eligibility for clinical trials. Most of the patients that were evaluated showed a positive response to treatment. Although this topic needs to be further assessed in large randomized controlled trials, these positive results emphasize the utility of liquid biopsy analysis to guide clinicians to select the right therapy for the right patient.
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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: 2
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.07-004 - Nivolumab for Non-Small Cell Lung Cancer (NSCLC): An Economic Model for Risk Sharing Based on Real-Life Data (ID 5452)
14:30 - 14:30 | Author(s): L.C. Roisman
- Abstract
Background:
Increasing costs of novel immunotherapy requires risk sharing between manufacturers and payers. Aside from the cost per dose of the compound, the total treatment cost (TTC) is affected by the duration of treatment (DOT). DOT in real life may differ significantly from that observed in the randomized clinical trials. The objective of this study was to develop a risk sharing strategy based on real world data for the use of nivolumab in NSCLC.
Methods:
We analyzed DOT for 260 consecutive patients with advanced NSCLC treated with nivolumab at five Israeli cancer centers between January 2015 and March 2016. We developed a model to incorporate the number of cycles delivered and to calculate the TTC for each patient. We calculated the “mid-point” (MP) to estimate the number of cycles for all patients to comprise half of the TTC for the population.
Results:
Median age 67y (range 41-99); males 68%; ECOG PS ≥2 46%; Non-squamous (Non-sq)/Squamous(Sq)/other histology 70%/23%/7%; treatment line: 1[st]/2[nd]/3[rd]+-line/NA 6%/64%/26%/4%. All patients received nivolumab as standard of care or within the compassionate use program. Median duration of follow-up was 4.3 mo (range 0.1-13.8); 27% of patients continued the treatment at the time of data cut-off. Median DOT was 2.7 mo (range 0.1-15.5). Median number of treatment cycles delivered calculated from a total of 206 patients was 6 (range 1-26 and 1-23 for Sq and Non-sq NSCLC, respectively). TTC distribution according to the treatment cycle and MP for Non-sq and Sq NCSLC are presented in Figure 1 (A and B), respectively. Figure 1
Conclusion:
Based on current list prices in Israel, the estimated mid-point for total treatment cost is the 5[th] cycle for Non-Sq NSCLC and the 4[th] cycle for Sq NSCLC. Our data may represent a basis for risk sharing discussion between the payers and the manufacturers.
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P3.07-007 - Compassionate Use Program for New Cancer Drugs in Israel - Shortcut for Reimbursement Approval (ID 4873)
14:30 - 14:30 | Author(s): L.C. Roisman
- Abstract
Background:
Drug accessibility and reimbursement remains a major challenge across the globe. The Israeli Ministry of Health (MOH) approves drugs based on previous approval by the FDA and EMA-EU. Compassionate use programs (CPU) represent the use of a compound approved by the FDA/EMA-EU before its approval by local regulatory authorities. CPU provides accelerated access to novel compounds to patients otherwise unable to get the treatment.
Methods:
This is a retrospective analysis of 102 patients treated with nivolumab, osimertinib, or nintedanib within a CPU in a single tertiary Israeli cancer center. Basic patient demographics, different logistic treatment aspects and the time from FDA/EMA-EU approval to reimbursement approval for these compounds in Israel were analyzed.
Results:
We started Nintedanib program by July 2014 when the official MOH approval was 16 months later in Nov 2015. Osimertinib program was started a year before the official approval by MOH and was approved for reimbursement 4 months prior to drug registration. Nivolumab for Non-squamous was started 6 months before approval, while for Squamous the label was approved by MOH 2 months after starting the compassionate program. Reimbursement approval was received 6 months thereafter for nivolumab (Squamous NSCLC). Two out of the three drugs in the program were approved for reimbursement, one of them even before MOH registration. Figure 1
Conclusion:
Compassionate use programs allow access to new cancer drugs prior to their approval by the regulatory authorities, increases physicians' experience with novel compounds and may affect reimbursement approval.
