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Table 1 Sources and data cut-offs used in primary and additional ITCs

From: Indirect treatment comparison of dabrafenib plus trametinib versus vemurafenib plus cobimetinib in previously untreated metastatic melanoma patients

Outcome

COMBI-v

coBRIM

Data cut-off

Data source

Data cut-off

Data source

Efficacy outcomes

OS

Primary Analysis —March 2015

Additional analysis (without crossover)—April 2014

Additional analysis (LDH subgroups)—March 2015

Robert 2015b [29]

Robert 2015a [27]

Novartis Pharmaceuticals Corporation, unpublished observations

August 2015

Atkinson 2015 [30]

PFS

Primary analysis—March 2015

Robert 2015b [29]

January 2015

Larkin 2015c [32]

Additional analysis

LDH subgroups—April 2014

Novartis Pharmaceuticals Corporation, unpublished observations

ORR

April 2014

Robert 2015a [27]

January 2015

Larkin 2015c [32]

General adverse events

Any AE, any SAE, discontinuation due to AE, AE leading to death, any grade ≥3 AE

March 2015

Robert 2015b [29]

and Novartis Pharmaceuticals Corporation, unpublished observations

September 2014

EMA label [33, 34]

Any treatment-related AE, any dose interruptions/modifications

April 2014

Robert 2015a [27]

Specific adverse events

All specific adverse events except those highlighted in the row below

March 2015

Robert 2015b [29]

and Novartis Pharmaceuticals Corporation, unpublished observations

September 2014

EMA label

Keratocanthoma

May 2014

Larkin 2014 [21]

CuSCC—all grades

April 2014

Chills—all grades grade 3 to 5: alopecia, nausea, pyrexia, vomiting

March 2015

May 2014

EMA label

  1. AE Adverse event, CuSS cutaneous squamous cell carcinoma, D + T dabrafenib plus trametinib, ECOG Eastern Cooperative Oncology Group, EMA European Medicines Agency, ITC Indirect treatment comparison, LDH lactate dehydrogenase, OS Overall survival, ORR Overall response rate, PFS Progression-free survival, SAE Severe adverse event, V vemurafenib, V + C vemurafenib plus cobimetinib