Final follow-up results suggest Opdivo and Yervoy could be close to a cure for some people with advanced melanoma, shifting how doctors administer follow-up care.
A decade of follow-up on people with melanoma who were treated with cancer immunotherapy shows how two drugs have dramatically reshaped the outlook for the deadly skin cancer.
New data show people with advanced melanoma and treated with Bristol Myers Squibb's Opdivo and Yervoy in a clinical trial lived a median of six years following treatment. Before immunotherapy's arrival, people with advanced disease typically survived only six to nine months following diagnosis. The data were published Sunday in The New England Journal of Medicine and presented at a European cancer conference.
The trial also found people who received the combination treatment and eventually died from melanoma survived more than a decade at the median. Even those whose disease wasn't driven into complete remission had improved long-term outlooks.
"It's a real opportunity to reinforce hope and to start getting comfortable with the word 'cure,'" said Jedd Wolchok, a Weill Cornell Medicine oncologist who led the study and served as lead author on the NEJM paper, in an interview. "We saw that there were people dying of reasons other than melanoma when you follow them over 10 years."
The data come from a final analysis of a trial named CHECKMATE-067, which compared the Opdivo-Yervoy combination to Opdivo and Yervoy by themselves. Yervoy recruits the immune system to fight malignant cells, and was the first "checkpoint inhibitor" approved in cancer. Opdivo was the third such immunotherapy to gain U.S. approval. The two can be used together, because Yervoy hits a target known as CTLA4 while Opdivo is aimed at a different one called PD1.
Yervoy's initial approval was based on a trial that tested it against an experimental therapeutic vaccine. There, the immunotherapy reduced the risk of death by 34% and kept people alive on average 10 months, compared with six months for the vaccine.
In CHECKMATE-067, Bristol Myers randomized 945 study volunteers with melanoma that had spread or couldn't be removed with surgery into three roughly equal groups to take either the Opdivo-Yervoy combination, Opdivo alone or Yervoy alone.
The combination reduced the risk of death 47% compared to Yervoy alone. Patients taking the two drugs lived on average 72 months following treatment, compared to 20 months in those who took Yervoy alone.
When eliminating deaths from causes other than melanoma, 52% of study participants who received the combination were still alive at 10 years.
Among patients who disease hadn't progressed three years after receiving the combination, 86% were still living at 10 years. In the groups who got Opdivo alone and Yervoy alone, the numbers were 85% and 79%, respectively.
And when eliminating deaths from causes other than melanoma in this specific group, 10-year survival was 96% for the combination, 97% for Opdivo alone and 88% for Yervoy alone.
Wolchok said that finding should influence how doctors and patients view follow-up screening. "After five years I urge people to not get scanned," he said, pointing out the risk from radiation and unnecessary treatments from false positives.
An additional finding could give patients some hope even if immunotherapy doesn't put their disease into complete remission. Among those whose tumors shrank between 50% and 80%, 10-year survival was 72% for the combination treatment, 75% in Opdivo arm and 40% in the Yervoy group.
Wolchok said these results "show us that the remaining [cancerous] areas on imaging studies may not represent active cancer or at least not progressive cancer."