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

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). Methods: This retrospective observational analysis used Flatiron Health’s electronic health record-derived database from Oct 2015 - Jul 2016. Oct 2015 was chosen as the start date as both combo use of I+N and D+T had been approved by the FDA. Pts were aged ≥18 years with a MM diagnosis, tested BRAF+ prior to therapy, and treated with either I+N or D+T as 1L therapy. Baseline demographic and clinical characteristics, and treatment patterns were collected from structured data and unstructured data in physician notes, and were descriptively assessed. Kaplan-Meier (KM) analysis measured time to discontinuation. Statistical inferences were not planned in this study. Results: Among 76 BRAF+ pts, 62% (47) were treated with D+T as 1L, and 38% (29) were treated with I+N as 1L. Compared to D+T pts, lower proportion of I+N pts had a history of brain metastases (31% vs. 34%) and elevated ( > 333 IU/L) lactate dehydrogenase (10% vs. 19%), while a higher proportion of I+N pts reported ECOG performance status score of zero (38% vs. 23%). The two cohorts were similar in age, gender and baseline comorbidities. Discontinuation among D+T and I+N was 43% (20) and 48% (14) respectively. The primary reason for discontinuation was progression among D+T pts (10/20) vs. toxic effects of therapy among I+N pts (8/14). KM median time to discontinuation was 213 days for D+T pts vs. 196 days for I+N pts. 55% of I+N pts did not complete full induction of 4 doses of ipilimumab, citing toxic effects of therapy. Conclusions: 1L D+T patients had higher tumor burden, elevated LDH levels, and higher ECOG performance status score, but lower discontinuation rate and longer time to treatment discontinuation relative to BRAF+ 1L I+N pts.

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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 197)

DOI

10.1200/JCO.2018.36.5_suppl.197

Abstract #

197

Poster Bd #

K6

Abstract Disclosures

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