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Found 1 Presentation For Request "1111P"
1111P - Suboptimal real-world (RW) outcomes for BRAF+ metastatic melanoma (MM) patients in 2L therapy (The NOBLE study series)
- Ahmad A. Tarhini (Pittsburgh, PA, United States of America)
Abstract
Background
Targeted Therapy (TT) and immuno-oncology (IO) based therapy have each demonstrated significant clinical benefits when used in 1L for BRAF+ MM patients. However, there is very limited data available on characteristics and outcomes once MM patients progress on 1L treatment. To address this data gap, this study examined real-world disease severity, progression free survival (PFS) and overall survival (OS) outcomes in BRAF+ MM patients receiving 2L therapy and compared them to outcomes observed in 1L.
Methods
The study included RW BRAF+ MM patients who received 1L (n=1010) and 2L (n=358) IO or TT therapy according to NCCN guidelines from Jan 1, 2014 up to Dec 31, 2018. Data was abstracted from >150 academic and community sites in the US (NOBLE study). Patient characteristics at the time of initiation of 1L and 2L were compared descriptively. Kaplan-Meier survival curves were used to compare rwPFS and OS in both 1L and 2L settings.
Results
At 1L initiation, 68% of RW patients met criteria for high tumor burden (high LDH and/or 3+ organ sites of metastasis). Median PFS following 1L therapy was 6.4 months in this RW patient population. Upon 2L initiation, increase in disease severity was observed and 47% of patients had developed new sites of metastases. The median rwPFS dropped by 30% in 2L therapy to 4.6 months. The mortality rate nearly doubles in the patients requiring two lines of therapy (21%) vs patients requiring 1 line of therapy (12%) within the 1st year.
Conclusions
This RW analysis of BRAF+ MM patients demonstrates poor PFS and mortality estimates for those patients requiring a second line of therapy. Consideration should be given to identifying patients that may benefit from more intensive treatment upfront to maximize clinical benefit in 1L and delay patients’ transition to 2L. Further study and analyses are warranted to best understand RW outcomes as therapies in MM continue to evolve.
Time First line Second line Progression rate Median PFS Progression rate Median PFS 6 months 50% 6.4 months 58% 4.6 months 1 year 64% 75% 2 years 75% 87%
Legal entity responsible for the study
Novartis.
Funding
Novartis.
Disclosure
A.A. Tarhini: Advisory/Consultancy: Novartis; Advisory/Consultancy: Genentech-Roche; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: Partner Therapeutics; Research grant/Funding (self), Contracted Research: OncoSec; Research grant/Funding (self), Contracted Research: Clinigen. A. Betof Warner: Honoraria (self): Nanobiotix, Inc; Honoraria (self): LG Chem Life Sciences, Inc; Honoraria (self): Iovance, Inc. B. Kang, A. Nakasato, M. Vance, Y-L. Ling, J. Patel: Full/Part-time employment: Novartis. J. Tang: Research grant/Funding (self): Novartis. All other authors have declared no conflicts of interest.