Bristol-Myers Squibb Company announced that the Data Monitoring Committee (DMC) analysis showed evidence that patients receiving Nivolumab fared better than the control group. This led to the halt of its random comparative evaluation of dacarbazine (DTIC) versus Nivolumab in patients with untreated BRAF advanced melanoma.
The Phase 3 study called CheckMate -066 observed 418 patients, testing Nivolumab as the first therapy for patients with the deadliest type of skin cancer, advanced melanoma with around 75 percent of patients dying within a year. These patients had not received any treatment for the disease and could not undergo surgery. Patients in the study will now be allowed to take Nivolumab. After the company announced its findings, Bristol-Myers shares rose to almost three percent.
A regimen which combines Nivolumab with Yervoy could be used as a treatment for melanoma. Nivolumab is not yet approved but the company is already preparing to file for the drug approval as treatment for non-small cell lung cancer.
After Bristol-Myers found that Nivolumab shrank the tumors in 18 percent of patients with advanced lung cancer, 27 percent of patients with kidney cancer and 28 percent of patients with melanoma, immune therapy research accelerated immediately.
Cancer cells exploit checkpoint and other regulatory pathways to escape from the immune system and protect the tumor from it. Nivolumab is a fully-human, investigational PD-1 immune checkpoint inhibitor which binds to programmed death-1 checkpoint receptor through activated T-cells. Researchers are studying whether nivolumab would allow the immune system to recognize and destroy cancer cells by blocking the pathway.
"The outcome of CheckMate -066 represents the first well-controlled, randomized Phase III trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit," Bristol oncology development head Michael Giordano said.
Melanoma is a type of skin cancer which uncontrollably grows pigment-producing cells called melanocytes in the skin. Metastatic melanoma is known to be the most aggressive and deadliest type of the disease and it occurs when cancer already spread beyond the skin surface to other body organs including the lungs, lymph nodes, brain and others. Melanoma has increased for the past 30 years. There were around 232,130 melanoma cases diagnosed globally in 2012. The disease is most curable during its early stages but in the last stages, the average survival rate is six months.