Abstract 211P
Background
The ATLAS trial compared axitinib (AXI) vs placebo in patients (pts) with locoregional renal cell carcinoma at risk of recurrence after nephrectomy. ATLAS was stopped due to futility at a pre-planned interim analysis. A subgroup analysis was performed to describe differences between Asian vs Non-Asian pts and different Asian groups by geography in baseline characteristics and safety.
Methods
The exploratory subgroup analysis population included 363 pts randomized to receive AXI and 361 randomized to placebo. The primary endpoint was disease-free survival (DFS).
Results
DFS had the largest treatment effect in highest risk pts for Asian and Non-Asian pts: Hazard ratio = 0.731 (Asians) vs. 0.755 (Non-Asians). A similar trend was noted for Fuhrman Grade 3-4. Additional key results from the analysis are presented in the table.
Table: 211P Summary of key findings
Axitinib N = 363 | Placebo N = 361 | |||
---|---|---|---|---|
Asian N = 262 | Non- Asian N = 101 | Asian N = 264 | Non- Asian N = 97 | |
Key Pts Characteristics | ||||
Pts in Highest Risk Group, % | 51.9 | 72.3 | 51.5 | 66.0 |
Median time since diagnosis, wk | 8.7 | 10.3 | 8.6 | 10.0 |
Drug Treatment Differences | ||||
Completed 3y Treatment, % | 31.5 | 15.0 | 31.1 | 15.6 |
Median Treatment Duration, mo | 25.3 | 15.6 | 27.0 | 22.9 |
Median Daily Dose, mg | 6.6 | 8.6 | 9.9 | 10.0 |
Pts Safety Experience | ||||
Frequency of Dose Reduction, % | 68.5 | 50.0 | 11.7 | 7.3 |
AE Leading to Dose Reduction, % | 58.8 | 46.0 | 7.6 | 10.4 |
AE Leading to Discontinuation, % | 27.3 | 15.0 | 12.1 | 10.4 |
AE=adverse events Asian pts on AXI had higher frequencies of proteinuria, hypothyroidism, and nasopharyngitis and lower frequencies of fatigue and asthenia compared to Non-Asian pts on AXI. Within major Asian groups, proteinuria, hypothyroidism, nasopharyngitis and hypertension were more common in Japanese > Korean > Chinese pts.
Conclusions
DFS did not vary based on ethnicity. Asian pts had a lower median daily dose, and more frequent dose reduction vs non-Asian pts. More Asian pts had AEs leading to dose reductions of AXI and study withdrawals vs non-Asian pts. There were notable differences in AEs between Asian and Non-Asian pts and between Japanese, Korean and Chinese pts.
Clinical trial identification
NCT01599754.
Editorial acknowledgement
The study is sponsored by Pfizer. Medical writing support was provided by Charles Cheng, MS, of Engage Scientific Solutions, and funded by Pfizer.
Legal entity responsible for the study
This study was sponsored by Pfizer Inc and SFJ Pharmaceuticals.
Funding
This study was sponsored by Pfizer Inc and SFJ Pharmaceuticals.
Disclosure
C.F. Ng: Advisory / Consultancy, Speaker Bureau / Expert testimony: Boston Scientific; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Janssen; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (institution): Astellas; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Ferring; Speaker Bureau / Expert testimony: Amgen; Research grant / Funding (institution): Olympus. T.G. Kwon: Research grant / Funding (institution): Kyungpook National University Chilgok Hospital. M. Eto: Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): ONO; Advisory / Consultancy, Speaker Bureau / Expert testimony: Bristol-Myers Squibb; Advisory / Consultancy, Speaker Bureau / Expert testimony, Research grant / Funding (self): Pfizer; Advisory / Consultancy, Speaker Bureau / Expert testimony: Novartis; Speaker Bureau / Expert testimony: Bayer. S.I. Seo: Honoraria (self): Ipsen; Honoraria (self): Pfizer; Research grant / Funding (self): Alvogen. B. Rosbrook: Shareholder / Stockholder / Stock options, Full / Part-time employment: Pfizer. E. Grande: Honoraria (self), Research grant / Funding (self): Pfizer; Honoraria (self): Bristol-Myers Squibb; Honoraria (self), Research grant / Funding (self): IPSEN; Honoraria (self), Research grant / Funding (self): Roche; Honoraria (self): Eisai; Honoraria (self): Eusa Pharma; Honoraria (self): MSD; Honoraria (self): Sanofi-Genzyme; Honoraria (self): Adacap; Honoraria (self): Novartis; Honoraria (self): Pierre Fabre; Honoraria (self), Research grant / Funding (self): Lexicon; Honoraria (self): Celgene; Research grant / Funding (self): AstraZeneca; Research grant / Funding (self): MTEM/Threshold. M. Gross-Goupil: Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: Pfizer; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: BMS; Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: MSD; Advisory / Consultancy, Research grant / Funding (self): Ipsen; Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen. D.I. Quinn: Advisory / Consultancy: Pfizer; Advisory / Consultancy: Bayer; Advisory / Consultancy: Novartis; Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: Merck; Advisory / Consultancy: Exelixis; Advisory / Consultancy: Genentech; Advisory / Consultancy: Roche; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Astellas. All other authors have declared no conflicts of interest.
Resources from the same session
329P - High-level expression of HDAC10 is associated with PD-L1 expression and poor prognosis in patients with non-small cell lung cancer receiving pulmonectomy
Presenter: Xiaomei Liu
Session: Poster display session
Resources:
Abstract
331P - A retrospective analysis of immune checkpoint therapy in patients with non-small cell lung cancer: Focus on thyroid disorder
Presenter: Sawana Ono
Session: Poster display session
Resources:
Abstract
332P - Analyse the association between adverse events (AEs) and survival in patients treated with immune checkpoint inhibitors (ICIs)
Presenter: Chi-yuan Cheng
Session: Poster display session
Resources:
Abstract
333P - Study of searching on efficacy of immune checkpoint inhibitor for the non-small cell lung cancer using FDG-PET/CT and thallium SPECT
Presenter: KAYOKO Kibata
Session: Poster display session
Resources:
Abstract
334P - Incidence and characteristic of adrenal insufficiency due to immune checkpoint inhibitors therapy
Presenter: Daisuke Etoh
Session: Poster display session
Resources:
Abstract
335P - PD-L1 profile of nasopharyngeal cancer patients in Indonesia
Presenter: Handoko Handoko
Session: Poster display session
Resources:
Abstract
336P - Pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for PD-L1-positive advanced non-small cell lung cancer in the real world
Presenter: Jun Sugisaka
Session: Poster display session
Resources:
Abstract
337P - Neutrophil-to-Lymphocyte ratio as a predictive factor for hyperprogressive disease in NSCLC patients treated with immune checkpoint inhibitor
Presenter: Ryo Takahashi
Session: Poster display session
Resources:
Abstract
338P - A new insight into tumour immune-evasion: Crosstalk between cancer stem cells and T regulatory cells
Presenter: Abhishek Dutta
Session: Poster display session
Resources:
Abstract
339TiP - PACIFIC-5: Phase III study of durvalumab after either concurrent or sequential chemoradiotherapy (CRT) in patients with stage III NSCLC
Presenter: Yi-Long Wu
Session: Poster display session
Resources:
Abstract