Nivolumab gets EU approval as a treatment of advanced melanoma

Nivolumab gets EU approval as a treatment of advanced melanoma

22 Jun 2015

The European Commission has approved nivolumab (Opdivo), a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. This approval allows for the marketing of 'Opdivo' in all 28 Member States of the EU. It follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which was announced on April 24, 2015.

Nivolumab is the only PD-1 immune checkpoint inhibitor to receive an accelerated assessment in Europe, and is the first approval given by the European Commission for a PD-1 inhibitor in any cancer.

Decreased risk of death for patients treated with nivolumab

The European Commission’s approval is based on data from two phase 3 studies (CheckMate -066, -037).

Together, the trials investigated nivolumab across treatment lines and mutational status with a consistent dose of 3 mg/kg every two weeks that has been well-established across the phase 3 clinical development program for nivolumab.

CheckMate-066 is a Phase 3 randomized, double-blind study comparing nivolumab to the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma.

It is the first phase 3 trial of a PD-1 immune checkpoint inhibitor to demonstrate:

• Superior overall survival in advanced melanoma, demonstrating a one-year survival rate of 73% for nivolumab versus 42% for DTIC
• There was a 58% decrease in the risk of death for patients treated with nivolumab based on a hazard ratio of 0.42.
• Objective response rate also was significantly higher for nivolumab than DTIC.

Adverse events of the treatments

Fewer discontinuations were observed with nivolumab than DTIC (6.8% vs. 11.7%) as well as for treatment-related Grade 3/4 adverse events (11.7% vs. 17.6%).

The most common nivolumab treatment-related adverse events were:

• Fatigue (20%),
• Pruritus (17%), and
• Nausea (16.5%).

Common adverse events in the DTIC arm were consistent with those in previous reports and included:

• Nausea (41.5%),
• Vomiting (21%),
• Fatigue (15%),
• Diarrhea (15%) and
• Hematological toxicities.

No deaths were attributed to study drug toxicity in either arm. Discontinuations due to drug-related adverse events of any grade occurred in 3% of nivolumab-treated patients and 7% of patients administered investigator’s choice chemotherapy.

New option for advanced melanoma patients in the European Union

“The phase 3 data supporting the approval of nivolumab demonstrates both superior overall survival and response rate for treatment-naïve patients with advanced melanoma, against the standard of care,” said Dirk Schadendorf, M.D., professor, director and chair, Clinic for Dermatology, University Hospital, Essen, Germany.

“It is an important step forward in offering a new option for advanced melanoma patients in the European Union, especially considering that long-term benefits have largely been elusive in this treatment category.”

Source: eCancer News