Relapse-Free Survival With Adjuvant Dabrafenib/Trametinib Therapy in Patients With BRAF V600-mutated Stage III/IV Melanoma

Novartis38 enrolled

Overview

This was a retrospective chart review study of all proto-oncogene B-Raf (BRAF) V600-mutated patients who received adjuvant checkpoint inhibitor (CPI) therapy, relapsed locoregionally or distantly, and were again resected to no evidence of disease (NED) and treated with adjuvant dabrafenib and trametinib (dab/tram) combination therapy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

BRAF V600 Mutated-Stage III/IV Melanoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient at least 18 years of age at the time of diagnosis of stage III/IV melanoma. * Received surgical resection with no residual disease following initial stage III/IV melanoma diagnosis. * Documented local or central assay-positive for tumor BRAF V600E/K mutation. * Received adjuvant CPI alone or in combination with any other immune treatment as their first adjuvant therapy. * Following adjuvant CPI, relapsed (locoregionally or distantly) on or off treatment and was again rendered free of disease after subsequent surgical resection. * Received additional adjuvant dab/tram combination therapy after failing adjuvant CPI and being subsequently resected to NED. Exclusion Criteria: * Previous administration of any BRAF- or mitogen-activated protein kinase (MEK)-targeted therapies. * More than 120 days duration between surgery to render the patient NED after relapsing during or after adjuvant CPI therapy and initiation of dab/tram adjuvant therapy. * Administration of any intervening antitumor medical and/or radiation therapy between failing adjuvant CPI and initiation of adjuvant dab/tram.

Locations (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Relapse-free Survival-2 (RFS-2)

RFS-2 was defined as the time from the study index date until the date of the earliest clinician-documented disease progression, death, or start of a new line of anticancer treatment due to disease progression. Patients without a progression event as described above were censored at the last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.

Time frame: Up to 63 months

Secondary Outcomes

Overall Survival (OS)

OS was defined as the time from the study index date until death due to any cause. Patients without a death event were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.

Time frame: Up to 63 months

Distant Metastases-free Survival (DMFS)

DMFS was defined as the time from the study index date until the first observation of disease progression with distant metastasis. Patients without a DMFS event as described above were censored at last available follow-up, defined as last known clinic visit or last known contact with the patient (if occurred outside the clinic setting). Index date was defined as the date that dab/tram combination therapy was initiated after being rendered disease-free for a second time following additional resection after prior relapse on initial CPI adjuvant therapy.

Time frame: Up to 63 months

Number of Patients with an Adverse Event (AE) Related to Dabrafenib and Trametinib Combination Therapy

Data from ClinicalTrials.gov

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