Background
A significant period until disease progression was seen in patients with metastatic renal cell cancer (RCC) receiving the triplet combination of Cometriq plus Yervoy and Opdivo, according to a study presented at the annual meeting of the European Society for Medical Oncology, held Sept. 9 to 13 in Paris.
The name of the study is “COSMIC-313”.
About the Study
The COSMIC-313 phase 3 trial compared the modern active control of doublet therapy (Opdivo plus Yervoy) to triplet therapy (Cometriq plus Yervoy and Opdivo) for first-line treatment of metastatic RCC.
855 previously untreated renal cell cancer patients were randomly assigned to Cometriq (40 mg daily; 428 patients) or placebo (427 patients).
All patients received Opdivo (3 mg/kg every three weeks) plus Yervoy (1 mg/kg every three weeks) for four cycles followed by Opdivo (480 mg every four weeks for up to two years).
Study Outcomes
The international group of researchers found that the primary endpoint which was the period until disease progression was achieved in the triplet therapy group:
The was a reduction of 27% in the risk of disease progression or death in the triplet group.
43 percent of patients experienced a shrinkage in tumor size for those receiving triplet therapy versus 36 percent for those receiving doublet therapy.
Median period until disease progression was not yet reached for patients receiving triplet therapy but was 11.3 months for patients receiving doublet therapy.
Side Effects
As might be anticipated with treatment intensification, side effects were higher with the triplet combination. No new safety signals were identified for any of the components.
Nearly three-fourths of patients receiving triplet therapy experienced harsh side effects versus 41 percent with doublet therapy.
Discontinuation of all treatment components due to treatment-related side effects occurred in 12 percent of patients receiving triplet therapy versus 5 percent receiving doublet therapy.
Conclusion
We must see next how to integrate this regimen – Cometriq plus Yervoy and Opdivo – into practice as first line treatment in metastatic renal cancer, if approved by regulatory authorities.
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