Novartis Pharmaceuticals Corporation, East Hanover, NJ
Sameer Ghate, Jackson Tang, Zhiyi Li, Antonio Reis Nakasato
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] |
Discontinued | 6 | 46.2% | 6 | 40.0% | 8 | 66.7% | 11 | 47.8% |
KM median time to discontinuation (days) | 134 | 189 | 225 | 198 | ||||
Reason for discontinuation | ||||||||
Treatment toxicity | 4 | 30.8% | 0 | 0% | 3 | 25.0% | 4 | 17.4% |
Progression | 2 | 15.4% | 5 | 33.3% | 4 | 33.3% | 7 | 30.4% |
Disease related | 0 | 0% | 0 | 0% | 0 | 0% | 0 | 0% |
Other | 0 | 0% | 1 | 6.7% | 1 | 8.3% | 0 | 0% |
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Abstract Disclosures
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