The FDA has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This approval expands the original indication for the nivolumab + ipilimumab regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which progression-free survival (PFS) and overall survival (OS) were co-primary endpoints. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent on demonstrated clinical benefit in additional trials.
CheckMate-067 evaluated previously untreated patients, including both BRAF V600 mutant and wild-type advanced melanoma, and enrolled 945 patients who were randomized to receive the nivolumab + ipilimumab regimen (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks thereafter; n=314), nivolumab monotherapy (nivolumab 3 mg/kg every 2 weeks; n=316) or ipilimumab monotherapy (ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks; n=315). Patients were treated until progression or unacceptable toxic effects. Results from the trial demonstrated a statistically significant improvement in PFS in patients with advanced melanoma treated with the nivolumab + ipilimumab regimen and with nivolumab as a single-agent vs. ipilimumab monotherapy. In addition, the nivolumab + ipilimumab regimen and nivolumab monotherapy demonstrated higher confirmed objective response rates vs. ipilimumab monotherapy.
“Patients with metastatic melanoma historically have a very challenging disease. Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope. The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” said Jedd D. Wolchok, MD, PhD, chief, melanoma and immunotherapeutics service, department of medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center. “This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an immuno-oncology combination treatment, and the potential for improved outcomes.”
The FDA has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This approval expands the original indication for the nivolumab + ipilimumab regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which progression-free survival (PFS) and overall survival (OS) were co-primary endpoints. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent on demonstrated clinical benefit in additional trials.
CheckMate-067 evaluated previously untreated patients, including both BRAF V600 mutant and wild-type advanced melanoma, and enrolled 945 patients who were randomized to receive the nivolumab + ipilimumab regimen (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks thereafter; n=314), nivolumab monotherapy (nivolumab 3 mg/kg every 2 weeks; n=316) or ipilimumab monotherapy (ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks; n=315). Patients were treated until progression or unacceptable toxic effects. Results from the trial demonstrated a statistically significant improvement in PFS in patients with advanced melanoma treated with the nivolumab + ipilimumab regimen and with nivolumab as a single-agent vs. ipilimumab monotherapy. In addition, the nivolumab + ipilimumab regimen and nivolumab monotherapy demonstrated higher confirmed objective response rates vs. ipilimumab monotherapy.
“Patients with metastatic melanoma historically have a very challenging disease. Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope. The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” said Jedd D. Wolchok, MD, PhD, chief, melanoma and immunotherapeutics service, department of medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center. “This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an immuno-oncology combination treatment, and the potential for improved outcomes.”
The FDA has approved nivolumab (Opdivo) in combination with ipilimumab (Yervoy) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. This approval expands the original indication for the nivolumab + ipilimumab regimen for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma to include patients, regardless of BRAF mutational status, based on data from the Phase 3 CheckMate -067 trial, in which progression-free survival (PFS) and overall survival (OS) were co-primary endpoints. This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent on demonstrated clinical benefit in additional trials.
CheckMate-067 evaluated previously untreated patients, including both BRAF V600 mutant and wild-type advanced melanoma, and enrolled 945 patients who were randomized to receive the nivolumab + ipilimumab regimen (nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by Opdivo 3 mg/kg every 2 weeks thereafter; n=314), nivolumab monotherapy (nivolumab 3 mg/kg every 2 weeks; n=316) or ipilimumab monotherapy (ipilimumab 3 mg/kg every 3 weeks for 4 doses followed by placebo every 2 weeks; n=315). Patients were treated until progression or unacceptable toxic effects. Results from the trial demonstrated a statistically significant improvement in PFS in patients with advanced melanoma treated with the nivolumab + ipilimumab regimen and with nivolumab as a single-agent vs. ipilimumab monotherapy. In addition, the nivolumab + ipilimumab regimen and nivolumab monotherapy demonstrated higher confirmed objective response rates vs. ipilimumab monotherapy.
“Patients with metastatic melanoma historically have a very challenging disease. Recent advances in our understanding of the immune response to cancer has yielded therapies which provide meaningful responses and hope. The combination of two immuno-oncology treatments, nivolumab and ipilimumab, has been shown to provide these patients with a much needed improvement in progression-free survival and response rates,” said Jedd D. Wolchok, MD, PhD, chief, melanoma and immunotherapeutics service, department of medicine and Ludwig Center at Memorial Sloan Kettering Cancer Center. “This expanded approval for the nivolumab and ipilimumab regimen provides more advanced melanoma patients with an immuno-oncology combination treatment, and the potential for improved outcomes.”
