Regulators have taken a step toward expanding the European Union’s approval of Opvido (nivolumab) as a melanoma treatment to an additional group of patients.
The step the European Medicines Agency took was accepting Bristol-Myers Squibb’s application to expand the therapy’s approval to advanced melanoma patients at high risk of their disease returning after surgical removal of their tumors.
Accepting an application that requests an additional treatment population is called validating it. This means an application is complete and that an approval can be revised.
Bristol-Myers based its application on new information from the ongoing Phase 3 CheckMate 238 clinical trial (NCT02388906) that it is sponsoring.
“Patients with advanced melanoma often face a poor prognosis and have a disease recurrence rate of 68% or greater, highlighting the need for more effective adjuvant treatments,” Murdo Gordon, Bristol-Myers Squibb’s executive vice president and chief commercial officer, said in a press release.
“The validation of our application by the EMA [European Medicines Agency] is another step forward in our effort to advance Immuno-Oncology treatments for patients with resected [surgically removed] high-risk advanced melanoma,” he added.
The randomized, double-blind Phase 3 trial is investigating whether Opdivo is better than another Bristol-Myers Squibb therapy, Yervoy (ipilimumab) at preventing the return of melanoma in patients who had surgery for the stage IIIb/c or stage IV forms of the cancer.
Researchers randomly assigned the 906 participants in the study to Opdivo, given intravenously every two weeks, or Yervoy every three weeks. Starting at week 24, patients were treated once every 12 weeks.
Ideally, participants were to be treated for up to one year. But treatment would be stopped if their melanoma returned, they experienced unacceptable toxicity, or they simply opted to withdraw from the trial.
The study’s primary goal was to see how long it took for patients’ melanoma to return. The secondary objective was to see how the treatments affected patients’ overall survival.
Researchers presented the results at the European Society for Medical Oncology 2017 Congress in Madrid, Sept. 8-12. They showed that advanced melanoma patients at high risk of recurrence after surgery do better with Opdivo than Yervoy.
At 18 months, 66.4 percent of patients in the Opdivo arm were still recurrence-free, compared with 52.7 percent in the Yervoy group. There were also fewer side effects with Opdivo than with Yervoy, researchers added.
The presenters’ poster session was titled “Adjuvant therapy with nivolumab (NIVO) versus ipilimumab (IPI) after complete resection of stage III/IV melanoma: a randomized, double-blind, phase 3 trial (CheckMate 238).” The team also published their findings in the New England Journal of Medicine under the title “Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma.”