Abstract 840P
Background
D + T has shown long-term efficacy and a well-characterised safety profile in pts with BRAF-mutant melanoma in clinical trials; however, real-world evidence (RWE) is limited. ePROs compiled with digital solutions can allow for collection of symptom data, prompt reaction to medical events, and improved quality of life (QOL). Novartis and Kaiku Health codeveloped a platform for pts with high-risk stage III or unresectable/metastatic BRAF V600E/K–mutant melanoma to describe PROs during treatment with D + T and provide pt educational materials.
Methods
40 to 100 pts will be enrolled during treatment with D + T and followed for ≥ 6 mo to collect longitudinal PRO and clinical data. The primary endpoint is incidence of key symptoms such as fever, chills, fatigue, and nausea. Secondary endpoints include frequency, severity, and duration of symptoms; platform feasibility and impact on treatment interruptions and/or reductions and time on treatment; and machine learning (ML) modelling aimed at predicting symptom onset and continuity.
Results
At data cutoff for the interim analysis (22 Mar 2022), 49 pts were enrolled from 5 sites. The adoption rate was 92%, with 45/49 invited pts registered, with 66% using the module for ≥ 12 wk. The majority (65%) used mobile versions, and 76% read electronic educational materials. 39/45 pts reported a total of 7217 symptoms using the module with a 71% average weekly compliance, and 39 pts completed ≥ 1 QOL questionnaire. Median time spent on questionnaires ranged from ≈ 2-3 minutes. Common symptoms were fatigue (82%), headache (56%), cough (51%), and muscle pain (51%). 10 pts reported 19 cases of acute fever and were monitored using a fever management algorithm until resolution. ML models predicted symptom onset and continuity for 9 symptoms with good to excellent performance.
Conclusions
Interim data suggest that modules are supporting pts while generating RWE, which opens the possibility of understanding safety profiles and QOL in this setting. Continued data collection and investigation of ML aim to better predict symptoms for earlier intervention.
Clinical trial identification
Editorial acknowledgement
Editorial assistance was provided by Alana Reed, PhD, and William Fazzone, PhD (ArticulateScience LLC), and was funded by Novartis Pharmaceuticals Corporation.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Disclosure
A. Addeo: Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly. P. Mohr: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Amgen, Roche, Merck, Pierre Fabre, Sanofi, Almirall Hermal GmbH; Financial Interests, Personal, Speaker’s Bureau: Novartis, Roche, Bristol Myers Squibb, Merck Sharp & Dohme, Amgen, Sanofi; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Amgen, Roche, Sun Pharma, Sanofi; Financial Interests, Personal, Other, Honoraria: Bristol Myers Squibb, Merck Sharp & Dohme, Roche/Genentech, Novartis, Amgen, Pierre Fabre, Merck, Sanofi, Almirall Hermal GmbH, Sun Pharma, Beiersdorf; Financial Interests, Institutional, Research Grant: Merck Sharp & Dohme, Bristol Myers Squibb, Novartis. P. Queirolo: Financial Interests, Personal, Advisory Role: Novartis, Roche, Pierre Fabre, BMS, MSD, Merck, Sanofi, Sun Pharma. J. Ekström: Financial Interests, Personal, Full or part-time Employment: Kaiku Health; Financial Interests, Personal, Stocks/Shares: Kaiku Health. J. Vainio: Financial Interests, Personal, Full or part-time Employment: Kaiku Health Ltd. V.V. Kataja: Financial Interests, Personal, Full or part-time Employment: Kaiku Health; Financial Interests, Personal, Leadership Role: Kaiku Health. F. Calado: Financial Interests, Personal, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. A. Fagan: Financial Interests, Personal, Full or part-time Employment: Novartis. M.R. Lau: Financial Interests, Personal, Full or part-time Employment: Novartis Pharma AG; Financial Interests, Personal, Stocks/Shares: Novartis Pharma AG. T. Romero Salas: Financial Interests, Personal, Full or part-time Employment: Novartis. H. Thole-Glettig: Financial Interests, Personal, Full or part-time Employment: Novartis. C.U. Blank: Financial Interests, Institutional, Advisory Role: Roche/Genentech, MSD Oncology, Bristol Myers Squibb, Novartis, GlaxoSmithKline, Pfizer, AstraZeneca, Lilly, Pierre Fabre, GenMab; Financial Interests, Personal, Advisory Role: Third Rock Ventures; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Uniti Cars, Immagene; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Novartis, NanoString Technologies. P.A. Ascierto: Financial Interests, Personal, Advisory Role: Bristol Myers Squibb, Roche/Genentech, Merck Sharp & Dohme, Novartis, Array BioPharma, Merck Serono, Pierre Fabre, Incyte, MedImmune, AstraZeneca, Sun Pharma, Sanofi, Idera, Ultimovacs, Sandoz, Immunocore, 4SC, Alkermes, Italfarmaco, Nektar, Boehringer Ingelheim, Eisai, Regeneron, Daiichi Sankyo, Pfizer, OncoSec, Nouscrom, Takis Biotech, Lunaphore Technologies, Seattle Genetics, ITeos Therapeutics, Medicenna; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Merck Sharp & Dohme; Financial Interests, Personal, Stocks/Shares: PrimeVax; Financial Interests, Institutional, Research Grant: Bristol Myers Squibb, Roche/Genentech, Array BioPharma, Sanofi. All other authors have declared no conflicts of interest.