Skin cancer patients may have a path to shrinking their advanced melanomas. An international trial tested a combination of ipilimumab and nivolumab on 925 patients with advanced melanoma. In 58 percent of cases, the cancer’s advance was halted for nearly a year.
The randomized phase III trial tested nivolumab (Opdivo) alone and in conjunction with ipilimumab (Yervoy). The findings are being presented at the American Society of Clinical Oncology conference in Chicago.
The combination proved to be “significantly more effective than ipilimumab alone.” Both drugs are in the immunotherapy class that act as checkpoint inhibitors. Essentially they work to boost the body’s immune system response to the tumors.
Both drugs are manufactured by Bristol Myers-Squibb, and the company is funding the trials. FDA approval has already been granted to both drugs to fight melanomas that cannot be removed by surgery, have spread to other organs or is not responding to other drug protocols.
The reason for the trials is the current FDA approval is for each drug to act as the sole option, not as a combination therapy.
Side Effects of Immunotherapy
On the surface, boosting your immune system to fight melanoma sounds like a winner. The issue is the side effects. Immunotherapy doesn’t work for everyone, and researchers are still trying to crack the puzzle.
In this trial, while tumor shrinkage was seen in nearly 60 percent of cases, 5 percent saw their tumors increase in size. Serious side effects were noted in more than half the patients assigned the combination therapy. 36 percent of patients in the drug combo group had to drop from the trial due to the severity of side effects.
It’s not to say cancer patients should discount it. Lead study author Jedd Wolchok, chief of melanoma and immunotherapeutics service at Memorial Sloan-Kettering Cancer Center in New York, said it was about finding the right balance of how long a patient has to be on the certain therapies for optimal results.
He noted that many of the 36 percent of patients that dropped from the trial still experienced benefits from immunotherapy.
“We’re very encouraged that the initial observations about the efficacy of this combination held up in this large phase III trial,” said Wolchok.
“Our study also suggests that patients with a specific tumor marker appear to benefit the most from the combination treatment, whereas other patients may do just as well with nivolumab alone. This will help doctors provide important insight for patients on which treatment is right for them.”
The quality of life assessments from trial participants are expected to be released at a later date.
Side effects can be controlled and reversed in patients. It would be up to the patient if they thought the benefits outweighed the possible side effects when taking the combination.
Skin Cancer Study Results
Breaking down the trial, it undoubtedly shows the combination of Opdivo and Yervoy worked the best in halting melanoma’s advance. On average, the combination threw the brakes on melanoma’s progression in patients for 11.5 months.
Taking the drugs alone resulted in halting the advance of melanoma, but for shorter time periods. Opdivo’s average came in at nearly seven months, while Yervoy stopped melanoma from progressing for nearly three.
Both drugs are monoclonal antibodies that block different immune checkpoints. Yervoy blocks CTLA-4, while Opdivo blocks PD-1. In conjunction, it makes it easier for the immune system to attack the tumors.
What’s Next for Advanced Melanoma Patients?
It’s a phase III trial, so Bristol could move to petition for approval of the treatment by the FDA. From there it would move to phase IV to monitor long-term efficacy and safety among a larger subset of the population.
The treatment is expensive. A four-dose treatment has a price tag of $160,000. Now the question is will the pharmaceutical company cut the price tag of the combination therapy?
Bristol Myers owns both drugs and could use it as leverage to prevent competing drugs from snapping away market share.