Bristol-Myers Squibb Co. revealed results of a study suggesting that treating patients suffering with advanced melanoma, the most deadliest form of skin cancer, through chemotherapy may become obsolete.
The study, presented at the Melanoma Research 2014 International Congress in Zurich, Switzerland, consisted of a Phase 3 randomized, double-blind tiral comparing Opdivo (nivolumab) to the chemotherapy dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.
Opdivo is an investigational PD-1 (programmed death 1) immune checkpoint inhibitor, that specifically blocks the PD-1 protein, a checkpoint receptor expressed on activated T-cells; ultimately it helps to mount and efficient anti-tumoral immune response.
The results, obtained in a late-stage study of the Bristol-Myers drug Opdivo were rated as impressive and published in The New England Journal of Medicine.
The study enrolled 418 patients, previously untreated, with advanced melanoma. Among those who were treated with Opdivo, 73 percent were alive one year after compared to only 42 percent of the patients treated with standard chemotherapy treatment dacarbazine.
About 40 percent of the patients treated with Opdivo actually had tumor shrinkage; only 14 percent of those treated with chemo had tumor shrinkage. Further, the treatment was associated with some mild secondary effects such as fatigue and also nausea.
Dr. Georgina Long, an associate professor at at the Melanoma Institute Australia that also collaborated and helped lead this study, said in a BMS press release: “The results were incredibly good and show there will no longer be a role for chemotherapy in advanced melanoma.” She added that these findings have a huge importance for Opdivo and Bristol-Myers as well as for all the PD-1 inhibitors being developed in other companies. Merck & Co, AstraZeneca Plc. and Roche Holding AG are also in the run to develop such drugs.
Opdivo obtained positive results in another Phase III trial, also enrolling patients with melanoma who had been previously treated with Yervoy (an immuno-oncology drug developed by Bristol-Myers), showing a higher rate of tumor shrinkage when compared with chemotherapy approaches.