Table 1.
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Robert 2015b [29] Robert 2015a [27] Novartis Pharmaceuticals Corporation, unpublished observations |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Novartis Pharmaceuticals Corporation, unpublished observations | |||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to AE, AE leading to death, any grade ≥3 AE | March 2015 | Robert 2015b [29] and Novartis Pharmaceuticals Corporation, unpublished observations |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except those highlighted in the row below | March 2015 | Robert 2015b [29] and Novartis Pharmaceuticals Corporation, unpublished observations |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 |
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