Abstract 1766
Background
Despite the availability of improved treatment options in BRAFV600 mutation-positive metastatic melanoma, key questions regarding therapy sequence and duration, tumor dynamics, as well as efficacy in patient subgroups (e.g. brain metastases, concomitant diseases) that were not included in previous phase III clinical trials remain unresolved. Therefore, the objective of this non-interventional prospective study (COMBI-r) was to assess the treatment of a broad patient population in metastatic melanoma with dabrafenib and trametinib in clinical routine.
Methods
Between December 2015 and December 2018, 504 patients at 58 German Skin Cancer Centers were enrolled in COMBI-r. This interims analysis focuses on efficacy (OS, PFS, ORR, DOR) and safety of dabrafenib and trametinib in patients treated for at least 1 year or who have already terminated treatment (approx. 330 patients). During the first year on treatment, visits were scheduled every 3 months, followed by half-yearly visits until end of treatment (EoT), and two follow-up visits at 3 and 6 months.
Results
Efficacy outcomes will be correlated with patient demographics at baseline as well as clinical, laboratory and biological parameters. In addition, patients will be assigned to slow, intermediate and fast tumor dynamic subgroups based on key baseline characteristics previously shown predictive of clinical benefit including tumor stage, organ involvement, therapy line and laboratory markers (S100, LDH).
Conclusions
Data from the COMBI-r interims analysis can provide insights as to whether efficacy and safety demonstrated in clinical trials as well as currently acknowledged predictive factors for clinical benefit and long-term outcomes are transferable to clinical routine. Further, it remains to be evaluated whether other criteria such as tumor dynamics are potentially suitable to predict outcomes in broader and more heterogeneous patient populations in metastatic melanoma.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Novartis Pharma GmbH.
Funding
Novartis Pharma GmbH.
Disclosure
C. Berking: Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : Amgen; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : BMS; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : MSD; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : Merck Serono; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : Novartis; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : Roche; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, institutional grants, personal fees and non-financial support : 4SC; Honoraria (self), Honoraria (institution), Advisory / Consultancy, Non-remunerated activity/ies, personal fees and non-financial support : Pierre Fabre; Honoraria (self), Non-remunerated activity/ies, personal fees and non-financial support : Sanofi-Aventis; Honoraria (self), Non-remunerated activity/ies, institutional grants : Array Pharma; Honoraria (self), Non-remunerated activity/ies, institutional grants : Regeneron; Honoraria (self), Non-remunerated activity/ies, institutional grant and personal fees (member of steering committee) related to the submitted work: Novartis. E. Livingstone: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy: Actelion; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy: Janssen; Honoraria (self), Advisory / Consultancy: Medac; Travel / Accommodation / Expenses: Pierre Fabre. M. Weichenthal: Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Sun Pharma. K. Wittmann: Full / Part-time employment: Novartis. T. Eigentler: Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Novartis; Advisory / Consultancy: Leo Pharma; Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: MSD. P. Mohr: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self), Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: GSK; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi-Aventis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre. F. Kiecker: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre. C. Loquai: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Merck; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: Amgen; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Sun Pharma. D. Debus: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pierre Fabre; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Sanofi. R. Gutzmer: Research grant / Funding (self): Pfizer; Research grant / Funding (self): Johnson&Johnson; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Novartis; Honoraria (self), Advisory / Consultancy, Research grant / Funding (self): Amgen; Advisory / Consultancy, Research grant / Funding (self): MerckSerono; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: BMS; Honoraria (self), Advisory / Consultancy: GSK; Honoraria (self): MSD; Honoraria (self), Advisory / Consultancy: Almirall-Hermal; Honoraria (self), Advisory / Consultancy: LEO; Honoraria (self), Advisory / Consultancy: Pierre Fabre; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self): 4SC; Advisory / Consultancy: Incyte; Advisory / Consultancy: SUN; Honoraria (self): Boehringer Ingelheim; Honoraria (self): AstraZeneca. All other authors have declared no conflicts of interest.
Resources from the same session
2494 - CAR-T Nursing Education at a UK Specialist Cancer Hospital
Presenter: Rose Ellard
Session: Poster Display session 3
Resources:
Abstract
2438 - Professional Quality of Life, Perceived Stress and Psychological Resistance Levels of Oncology-Hematology Nurses and the Factors Affecting
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
3541 - Representation of cancer survivors’ preferences in policies for supportive care: Implications for oncology nursing
Presenter: Samantha Mayo
Session: Poster Display session 3
Resources:
Abstract
5093 - Vaginal moisturizing post PDR-Pulse Dose Rate Brachytherapy.
Presenter: Pilar Fernández
Session: Poster Display session 3
Resources:
Abstract
1066 - The stomized, chemo and radiotreated patient vs untreated patient: complications and comparison with data literature
Presenter: Cristoforo Ferrero
Session: Poster Display session 3
Resources:
Abstract
1724 - Evaluating the role of clinical nurse specialist
Presenter: Anita Zeneli
Session: Poster Display session 3
Resources:
Abstract
3753 - Role of the Advanced Practice Nurse (APN) in a Functional Unit for Lung cancer at the Catalan Institute of Oncology
Presenter: Isabel Brao
Session: Poster Display session 3
Resources:
Abstract
2676 - A bottom-up approach for prioritising the scientific activities of the Italian Association of Cancer Nurses (AIIAO): rationale and topic identification
Presenter: Valentina Biagioli
Session: Poster Display session 3
Resources:
Abstract
575 - Investigating quality of care for people with cancer and dementia
Presenter: Naomi Farrington
Session: Poster Display session 3
Resources:
Abstract
5578 - Two years of BRCA1 and BRCA2 somatic External Quality Assessment with Gen&tiss Tiss scheme in France
Presenter: Kelly Dufraing
Session: Poster Display session 3
Resources:
Abstract