Immunotherapy for advanced melanoma prolongs survival in trial
24 Jun 2014
In a study, the immunotherapy drug "nivolumab" was used in advanced melanoma patients. Early results showed promise that it is likely to prolong survival.
This has led the company behind the drug (Bristol) to halt this phase 3 trial early on, for the most dangerous form of skin cancer.
418 patients for initial melanoma therapy
The 418-patient study was testing nivolumab as an initial, or first line, therapy for patients with advanced melanoma.
An interim analysis performed by an independent data-monitoring committee found evidence of superior overall survival in patients receiving nivolumab compared with those who received the chemotherapy dacarbazine, Bristol said. The committee stopped the study early to allow the dacarbazine patients to switch to the Bristol drug.
Nivolumab belongs to a new class of medicines called PD-1 inhibitors that have generated great excitement for their ability to help the immune system recognize and attack cancer.
Survival benefit expected, but its duration remains unclear
"The outcome [of the trial] ... represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit," Michael Giordano, Bristol's head of oncology development, said in a statement.
Independent monitors routinely analyze data from blinded trials at various points and can stop a study if a safety problem arises or if the study drug is seen as likely to prove clearly superior to the control medicine.
The duration of the survival benefit was not yet available. Bristol said it plans to complete a full evaluation of the trial data and work with researchers on a future presentation of the results.