Among patients with previously untreated, advanced melanoma, the addition of Yervoy™ (ipilimumab) to chemotherapy improved overall survival. The results of this Phase III clinical trial were presented at the 2011 annual meeting of the American Society of Clinical Oncology.
Yervoy targets a molecule known as CTLA4. CTLA4 is found on the surface of T cells and is thought to inhibit immune responses. By targeting this molecule, Yervoy may enhance the immune system’s response against tumor cells. Yervoy was approved in March, 2011 for the treatment of melanoma that has spread to other sites or cannot be surgically removed.
To evaluate the combination of Yervoy and the chemotherapy drug dacarbazine for the initial (first-line) treatment of advanced melanoma, researchers conducted a Phase III clinical trial among 502 patients with Stage III or Stage IV melanoma that could not be surgically removed. Study participants were treated with dacarbazine alone or in combination with Yervoy.
- Time to cancer progression was similar in the two study groups (2.8 months versus 2.6 months), but overall survival was better in the group that received Yervoy: three-year overall survival was 20.8% among patients treated with chemotherapy plus Yervoy, compared with 12.2% among patients treated with chemotherapy alone.
- Serious side effects were more common in the Yervoy group: grade 3 or grade 4 side effects occurred in 56% of patients treated with Yervoy and chemotherapy and in 27% of patients treated with chemotherapy alone.
This study provides additional evidence that Yervoy is active against advanced melanoma and can improve overall survival. Future research will evaluate the combination of Yervoy with other promising therapies, including the BRAF inhibitor vemurafenib.
Reference: Wolchok JD, Thomas L, Bondarenko IN et al. Phase 3 randomized study of ipilimumab (IPI) plus darcarbazine (DTIC) vs DTIC alone as first line treatment in patients with unresectable stage III or IV melanoma. Paper presented at: 2011 Annual Meeting of the American Society of Clinical Oncology; June 3-7, 2011; Chicago, IL. Abstract LBA5.
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