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J. Diebold
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MA16 - Novel Strategies in Targeted Therapy (ID 407)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
- Moderators:G. Purkalne, J. Von Pawel
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 2
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MA16.03 - Global RET Registry (GLORY): Activity of RET-Directed Targeted Therapies in RET-Rearranged Lung Cancers (ID 4325)
14:26 - 14:32 | Author(s): J. Diebold
- Abstract
- Presentation
Background:
GLORY is a global registry of patients with RET-rearranged non-small cell lung cancer (NSCLC). In order to complement ongoing prospective studies, the registry’s goal is to provide data on the efficacy of RET-directed targeted therapies administered outside the context of a clinical trial. We previously reported results from our first interim analysis (Gautschi, ASCO 2016). Following additional accrual into the registry, updated results are presented here, with a focus on an expanded efficacy analysis of various RET inhibitors.
Methods:
A global, multicenter network of thoracic oncologists identified patients with pathologically-confirmed NSCLC harboring a RET rearrangement. Molecular profiling was performed locally via RT-PCR, FISH, or next-generation sequencing. Anonymized data including clinical, pathologic, and molecular features were collected centrally and analyzed by an independent statistician. Response to RET tyrosine kinase inhibition (TKI) administered off-protocol was determined by RECIST1.1 (data cutoff date: April 15, 2016). In the subgroup of patients who received RET TKI therapy, the objectives were to determine overall response rate (ORR, primary objective), progression-free survival (PFS), and overall survival (OS).
Results:
165 patients with RET-rearranged NSCLC from 29 centers in Europe, Asia, and the USA were accrued. The median age was 61 years (range 28-89 years). The majority of patients were female (52%), never smokers (63%), with lung adenocarcinomas (98%) and advanced disease (91%). The most frequent metastasic sites were lymph nodes (82%), bone (51%) and lung (32%). KIF5B-RET was the most commonly identified fusion (70%). 53 patients received at least one RET-TKI outside of a clinical protocol, including cabozantinib (21), vandetanib (11), sunitinib (10), sorafenib (2), alectinib (2), lenvatinib (2), nintedanib (2), ponatinib (2) and regorafenib (1). In patients who were evaluable for response (n=50), the ORR was 37% for cabozantinib, 18% for vandetanib, and 22% for sunitinib. Median PFS was 3.6, 2.9, and 2.2 months and median OS was 4.9, 10.2, and 6.8 months for cabozantinib, vandetanib, and sunitinib, respectively. Responses were also observed with nintedanib and lenvatinib. Among patients who received more than one TKI (n=10), 3 partial responses were achieved after prior treatment with a different TKI.
Conclusion:
RET inhibitors are active in individual patients with RET-rearranged NSCLC, however, novel therapeutic approaches are warranted with the hope of improving current clinical outcomes. GLORY remains the largest dataset of patients with RET-rearranged NSCLC, and continues to accrue patients.
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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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P3.07-001 - Nivolumab for Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer: A Cost-Effectiveness Analysis including PD-L1 Testing (ID 3741)
14:30 - 14:30 | Author(s): J. Diebold
- Abstract
Background:
Nivolumab (NIV) is approved in several countries for pre-treated patients with advanced non-small cell lung cancer (NSCLC). UK NICE previously reported that NIV is not cost-effective compared with DOC for the treatment of squamous NSCLC. Here, we report cost-effectiveness for nonsquamous NSCLC, and consequences of patient selection by PD-L1 testing.
Methods:
Based on the published results of the CheckMate-057 trial (Borghaei et al, NEJM 2015), we performed a literature-based health economic modelling study to estimate the incremental cost-effectiveness ratio (ICER) of NIV versus DOC for the Swiss health care setting. We estimated the probability of reaching cost-effectiveness based on a willingness to pay (WTP) threshold of CHF100’000 per QALY gained. Moreover, we implemented patient selection for NIV treatment using PD-L1 staining, and modelled the effect of reducing the NIV price, dose, and treatment duration, on the ICER.
Results:
In the base case model, NIV (mean costs CHF 66’208; mean effect 0.69 QALYs) compared to DOC (mean costs CHF 37'618; mean effect 0.53 QALYs) resulted in an ICER of CHF 177’478 per QALY gained. Selecting patients for NIV by PD-L1 testing (threshold ≥10%), resulted in a base case ICER of CHF124’891 per QALY gained, compared to treating all patients with DOC. Reduction of NIV price, dose, or treatment duration, all reduced the ICER partially below an assumed WTP of CHF100’000 per QALY (see Table 1). Cost-effectiveness was strongly influenced by health state utilities. Table 1 Results of the base case and scenario analyses
DOC= docetaxel, NIV=Nivolumab, QALY= quality adjusted life years, ICER= incremental cost effectiveness ratio, CHF=Swiss FrancsScenario Treatment arm Cost (mean) Effect Month (mean) Effect QALY (mean) Compared to Incremental costs Incremental effect ICER CHF probability cost- effective Base case DOC 37'618 10.99 0.53 NIV 66’208 15.42 0.69 DOC 28’589 0.16 177’478 14.1% PD-L1 ≥1% 74'968 17.26 0.79 DOC 35’530 0.27 133’267 19.7% NIV 6'941 0.11 65’774 85.2% PD-L1 ≥10% 69’893 16.83 0.78 DOC 32’274 0.26 124’891 22.1% NIV 3’685 0.10 37’860 86.7%
Conclusion:
At its current price, NIV is not cost-effective compared with DOC for the treatment of patients with nonsquamous NSCLC. Price reduction and/or patient selection by PD-L1 testing would be highly recommendable from a socio-economic viewpoint.
