GlaxoSmithKline (GSK) announced that its late-stage metastatic melanoma trial significantly improved overall survival (OS).
The Phase III COMBI-d study evaluated the combination of the BRAF inhibitor, dabrafenib (Tafinlar), and the MEK inhibitor, trametinib (Mekinist), compared to single agent therapy with dabrafenib (Tafinlar) and placebo in patients with unresectable (Stage IIIC) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma. According to GSK, the combination treatment demonstrated a statistically significant reduction in the risk of death.
The study consisted of 423 patients who were randomized to receive the combination therapy or dabrafenib alone. The study’s primary endpoint was investigator assessed progression-free survival (PFS), and secondary endpoints included OS, objective response rate (ORR), duration of response (DoR) and safety. According to the company, the safety profile was consistent with the profile observed to date for the combination and no new safety concerns were observed.
“These final overall survival results from COMBI-d, the second phase III study to show positive survival results for the combination compared to BRAF inhibitor monotherapy, further reinforce the scientific rationale for combining MEK and BRAF inhibitors and underscore the potential of the combination of dabrafenib and trametinib in the treatment of BRAF V600 mutation-positive metastatic melanoma,” said Patrick Vallance, President, Pharmaceuticals R&D at GSK. “We are deeply grateful for the support and commitment of the patients, their families and the investigators who took part in this trial.”
Previous analyses from the study’s data showed that treatment with the combination resulted in a 25 percent reduction in the risk of disease progression and/or death compared to dabrafenib alone. The median PFS was 9.3 months in the treatment group compared to 8.8 months in the control group.
The US Food and Drug Administration (FDA) required the study be completed as a post-marketing requirement for the agency’s accelerated approval for the combination in the US. The final data from the late-stage trial will be submitted to regulatory authorities for review in the next few months.
Source: GlaxoSmithKline PLC