Real world treatment patterns of first-line combination therapies among BRAF+ metastatic melanoma patients stratified by tumor burden.

Authors

null

Sameer Ghate

Novartis Pharmaceuticals Corporation, East Hanover, NJ

Sameer Ghate, Jackson Tang, Zhiyi Li, Antonio Reis Nakasato

Organizations

Novartis Pharmaceuticals Corporation, East Hanover, NJ, Asclepius Analytics LLC, New York, NY

Research Funding

Pharmaceutical/Biotech Company

Background: For patients (pts) with metastatic melanoma (MM) and BRAF V600 mutation (BRAF+), options for first-line (1L) systemic combination therapy include immunotherapy (IO) or targeted therapy (TT). This study describes real world treatment patterns among BRAF+ MM pts treated with 1L ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T), stratified by tumor burden. Methods: A retrospective observational analysis used Flatiron Health’s electronic health record-derived database from Oct ’15 - Jul ’16. Pts were aged ≥18 years with a MM diagnosis, tested BRAF+ prior to therapy, and treated with ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T) as 1L therapy. Low tumor burden was defined as low/normal LDH (≤ 333 IU/L) and no brain metastasis. High tumor burden was defined as high LDH ( > 333 IU/L) or brain metastasis. Baseline characteristics and treatment patterns were descriptively assessed. Kaplan-Meier (KM) analysis measured time to discontinuation. Results: Among 76 BRAF+ pts, 38% (29) were treated with I+N as 1L, and 62% (47) were treated with D+T as 1L. Of these, 45% (13/29) of I+N vs. 32% (15/47) of D+T had low tumor burden, while 41% (12/29) of I+N vs. 49% (23/47) of D+T had high tumor burden. The two cohorts did not differ by age or gender. Treatment patterns are summarized below. Conclusions: Among pts with low tumor burden, I+N demonstrated shorter time to discontinuation and higher discontinuation rate relative to D+T. Treatment toxicity and progression was the main reason for discontinuation of I+N and D+T, respectively. Among pts with high tumor burden, I+N demonstrated longer time to discontinuation but higher discontinuation rate relative to D+T. Progression was the main reason for discontinuation of both I+N and D+T.

Low tumor burden
High tumor burden
I+N
D+T
I+N
D+T
N = 13
N = 15
N = 12
N = 23
N%N%N%N%
Treatment duration (days) [median, range]118[21, 353]155[55, 337]137[27, 527]111[40, 385]
Discontinued646.2%640.0%866.7%1147.8%
KM median time to discontinuation (days)134189225198
Reason for discontinuation
Treatment toxicity430.8%00%325.0%417.4%
Progression215.4%533.3%433.3%730.4%
Disease related00%00%00%00%
Other00%16.7%18.3%00%

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Abstract Details

Meeting

2018 ASCO-SITC Clinical Immuno-Oncology Symposium

Session Type

Poster Session

Session Title

Poster Session A

Track

Developmental Therapeutics,Genitourinary Cancer,Head and Neck Cancer,Lung Cancer,Melanoma/Skin Cancers,Gastrointestinal Cancer,Breast and Gynecologic Cancers,Combination Studies,Implications for Patients and Society,Miscellaneous Cancers,Oncolytic Viruses,Hematologic Malignancies

Sub Track

Immune Checkpoints and Stimulatory Receptors

Citation

J Clin Oncol 36, 2018 (suppl 5S; abstr 198)

DOI

10.1200/JCO.2018.36.5_suppl.198

Abstract #

198

Poster Bd #

K7

Abstract Disclosures

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Abstract

2018 ASCO-SITC Clinical Immuno-Oncology Symposium

Real world treatment patterns of first-line combination therapies among BRAF+ metastatic melanoma patients.

First Author: Sameer Ghate