Leonard Saltz of Memorial Sloan Kettering Cancer Center, who estimated earlier this year that the Opdivo-Yervoy combination would cost the average patient $295,000 for a little less than a year of treatment. The approval was based on results from the pivotal CheckMate-069 study and provides clinical rationale for targeting the immune system with two immuno-oncology agents in metastatic melanoma. The approval of this combination therapy is a major turning point, offering patients a new treatment option, and opens the door for many other synergistic therapies to emerge.
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Ipilimumab and nivolumab are two types of immunotherapy that help the body’s own immune system attack cancer cells.
The FDA has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for treatment of BRAF V600 wild-type melanoma. “[This] approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma”.
In 2011, Yervoy received approval and Opdivo was approved near the end of past year. Results from the trial demonstrated a statistically significant (p 0.001) increase in confirmed objective response rate – the study’s primary endpoint – in patients with BRAF wild-type melanoma treated with the Opdivo + Yervoy Regimen [60% (95% CI: 48-71; p 0.001)] compared to those treated with Yervoy monotherapy [11% (95% CI: 3-25)].
With this recent news, since MRA launched in 2007, nine therapies have been approved to treat melanoma including two approved drug combinations, drastically changing the outlook for patients with melanoma and other cancers.
Serious adverse reactions were more common in the patients receiving the combination regimen than for patients receiving Yervoy alone.
“What we don’t want to see is that cost becomes a factor in people getting the best kind of care that’s available”, said Tim Turnham, executive director of the nonprofit Melanoma Research Foundation.
The combination also showed a 60% reduction in the risk of progression verus Yervoy monotherapy: median progression-free survival was 8.9 months versus 4.7 months, respectively.
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Established in 1984, SITC is a non-profit organization dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology.
