2011 Top Game Changers in Oncology

Bruce D. Cheson, MD; David J. Kerr, MD; Mark G. Kris, MD; Maurie Markman, MD; John L. Marshall, MD; Kathy D. Miller, MD; Nancy R. Terry

Disclosures

November 23, 2011

In This Article

1. The Top Game Changer for 2011 in Oncology

Unprecedented Advances in Melanoma

In 2011, 2 studies and 2 drug approvals revolutionized therapy for patients with metastatic melanoma. Vemurafenib and ipilimumab quickly became household names after studies on their efficacies in metastatic melanoma were highlighted in the plenary session of the 2011 ASCO® annual meeting.

Vemurafenib. In a phase 3 study[10] that was accompanied by much praise and grand declarations, the targeted therapy vemurafenib was shown to dramatically improve progression-free and overall survival, compared with standard chemotherapy, in patients with advanced melanoma with no previous treatment.

Vemurafenib targets the V600E mutations in the BRAF gene, and an estimated 40%-60% of melanoma patients have this type of BRAF mutation.

The progression-free survival data constitute "an unprecedented level of difference," said lead author Paul Chapman, MD, from Memorial Sloan-Kettering Cancer Center.

This study is "practice changing," said Lynn Schuchter, MD, from the Abramson Cancer Center at the University of Pennsylvania in Philadelphia. Responses with the new oral therapy can be dramatic -- patients can have improvement within 72 hours of treatment, she said.

In August, vemurafenib was approved by the FDA for the first-line treatment of both metastatic and unresectable melanomas, as reported at the time by Medscape News. The drug is specifically indicated for patients with melanoma whose tumors have V600E mutations in the BRAF gene.

Ipilimumab. A phase 3, international, multicenter study showed ipilimumab, a human monoclonal antibody, to be effective as first-line therapy in both metastatic and unresectable melanoma.[11] The data on first-line use were presented at the 2011 ASCO® annual meeting and published online in The New England Journal of Medicine to coincide with the presentation.

Ipilimumab in combination with dacarbazine improved overall survival in patients with previously untreated metastatic melanoma, compared with dacarbazine plus placebo, said senior author Jedd Wolchok, MD, from Memorial Sloan-Kettering Cancer Center. The drug was approved by the FDA as first-line therapy for patients with unresectable or metastatic melanoma, based on a study of previously treated patients. At the time of its approval, ipilimumab was the first agent ever proven to improve survival in advanced melanoma, as reported at the time by Medscape.

Overall survival in the study was significantly longer in the ipilimumab group than in the placebo group (11.2 vs 9.1 months; hazard ratio [HR] for death, 0.72; P < .001), Dr. Wolchok and his coauthors reported. The ipilimumab group had higher survival rates than the placebo group at 1 year (47.3% vs 36.3%), 2 years (28.5% vs 17.9%), and 3 years (20.8% vs 12.2%). The 3-year results are "very mature," commented Dr. Wolchok.

On the basis of this study, ipilimumab was approved by the FDA for first-line treatment of both metastatic and unresectable melanomas.

"Today we are in the very fortunate position of having 2 medicines approved for metastatic melanoma, the first time in 13 years that any medicine has been approved by the FDA for melanoma," said Dr. Wolchok. "Importantly, both of these medicines were approved on the basis of the gold standard endpoint -- namely, improvement of overall survival. We believe these newly approved treatments are a source of great hope to patients, their families, and their physicians."

View 2 complete commentaries by Jedd Wolchok, MD, and read the original Medscape News stories on vemurafenib and ipilimumab.

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