Recent FDA Approval Follows Melanoma Clinical Research Trial Results

Opdivo & Yervoy Combination to Fight Advanced Melanoma

Following Bristol-Myers Squibb’s CheckMate-067 phase 3 clinical research trial in patients with previously untreated advanced melanoma, the FDA has approved the combination Opdivo and Yervoy drug. Opdivo and Yervoy, BMS’s first melanoma immunotherapy, achieved an expanded combination approval in 2011 for just those with the negative BRAF mutation.

Prior to this grant, patients with GRAF V600 wild-type mutation-positive unresectable or metastatic melanoma were not included in the target clinical audience. Now, patients with late stage melanoma of differing BRAF mutational statuses will have the opportunity for treatment as well.

Of the varying types of melanoma, metastatic melanoma causes the most damage. The cancer spreads beyond the skin layer, reaching other organs and often times causing organ failure. Cancer cells spread throughout the regulatory pathways, where they are undetected by the usual immune system defensive line. Opdivo and Yervoy work as immune checkpoint inhibitors of the checkpoint pathways, Opdivo targeting the PD-1 regulatory pathway with Yervoy targeting the CTLA-4 pathway.

CheckMate-067 BMS Clinical Research Trial

Chris Boerner, head of US Commercial for Bristol-Myers Squibb said, “CheckMate-067 is the first phase 3 study to observe the efficacy and safety of both Opdivo as a single-agent as well as in combination with Yervoy versus Yervoy alone. To make this treatment option available to more patients is truly a milestone in the fight against this deadly disease.”

The phase 3 clinical trial was double-blinded and randomized in order to compare Opdivo as a solo treatment against Opdivo + Yervoy, and against Yervoy alone. 945 patients were randomized into the three regimen groups, including patients with BRAF V600 mutation and wild-type advanced melanoma. Both the Opdivo and the combination Opdivo/Yervoy beat the solo Yervoy treatment in fighting off melanoma in previously untreated patients. Yervoy alone had a progression-free survival time of 2.9 months and Opdivo alone a survival time of 6.9 months, while the combo drug had a time of 11.5 months.

Other Melanoma Research: Roche’s Atezolizumab

While BMS’s Opdivo and Merck’s Keytruda target the PD-1 regulatory pathway, Roche’s atezolizumab drug targets the PD-L1 regulatory protein, bringing a different approach to the melanoma research. Roche believes that with the current data on PD-L1 already existing in a range of cancers, atezolizumab can show results with combination-therapy studies than presently realized.

“The melanoma community is excited to see the ongoing developments in research from the pharmaceutical industry, including Bristol-Myers Squibb, who made the first approved combination of 2 Immuno-Oncology treatments available to more patients fighting this disease,” said Tim Turnham, executive director of the Melanoma Research Foundation.

Currently, Opdivo and Keytruda are the key players in immune-oncology research for melanoma and lung cancer. But with the same goal in mind, Roche hopes to utilize their focus on PD-L1 for future growth in developing the melanoma cure.

You Can Help Too By Signing Up For A Clinical Research Trial!

With FDA approval such as this, more affected patients are included in the approved population for clinical research trials. With greater audience reach comes greater amount of data, a greater chance for successful treatments. Sign up with Clinical Trial Spotlight, and you too can participate in trials like this that are on the forefront of medicine, with new hopeful cures to conditions that were once thought to be hopeless. Together, we can shine a spotlight on these diseases weaknesses and help put an end to them once and for all.