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Association details:
| Biomarker: | BRAF V600 + LDH elevation |
|---|---|
| Cancer: | Melanoma |
| Drug: | Mekinist (trametinib) (MEK inhibitor) + Tafinlar (dabrafenib) (BRAF inhibitor) + spartalizumab (PDR001) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
The anti–PD-1 antibody spartalizumab in combination with dabrafenib and trametinib in advanced BRAF V600–mutant melanoma: Efficacy and safety findings from parts 1 and 2 of the Phase III COMBI-i trial.
Published date:
05/13/2020
Excerpt:
COMBI-i is investigating first-line spartalizumab 400 mg every 4 wk + dabrafenib 150 mg twice daily + trametinib 2 mg once daily in pts with unresectable or metastatic BRAF V600–mutant melanoma...In pts with elevated LDH, ORR was 67%, with 4 CRs (27%); median PFS was 10.7 mo (95% CI, 4.6-19.1 mo), and median OS was NR. The estimated 24-mo PFS and OS rates in these pts were 26.7% and 52.5%, respectively.
DOI:
10.1200/JCO.2020.38.15_suppl.10028
Trial ID:
Source:
Title:
The anti–PD-1 antibody spartalizumab (S) in combination with dabrafenib (D) and trametinib (T) in previously untreated patients (pts) with advanced BRAF V600–mutant melanoma: Updated efficacy and safety from parts 1 and 2 of COMBI-I.
Published date:
02/07/2020
Excerpt:
In pts with high baseline LDH: ORR was 67%, with 3 CRs (20%), median PFS was 10.7 mo (events in 10/15 pts [67%]), and median OS was not reached, with events in 6/15 pts (40%).
Trial ID:
