This news release describes a phase 1b trial to test whether injecting an immune stimulant directly into metastatic melanoma lesions would change the environment around the tumor in ways that would make an immunotherapy drug, pembrolizumab (Keytruda), more effective.
But it’s important the readers are left primarily with the understanding that the results are from the dose-escalation phase–the part of a clinical trial where the researchers look to determine the “best” dose, typically meaning the highest dose that can be used without causing adverse symptoms or side effects.
The study was not designed to see whether this approach was better than the approach currently used, or if it helped some people with metastatic melanoma live longer.
Yet, the headline states: Combination approach shows promise for beating advanced melanoma.
The sub-headline asserts, “the new treatment is more effective in people receiving immunotherapy for the first time.”
And the first paragraph asserts that “a treatment that uses a bacteria-like agent in combination with an immunotherapy drug could help some people with advanced melanoma … live longer.”
None of that is known yet.
It also is notable that the release made no mention of side effects among patients given this combination of therapies–even though that’s what this trial was examining.
Immunotherapy has seen some of its greatest success in the treatment of metastatic melanoma. But it doesn’t work in all patients. Scientists hope by learning why it doesn’t always work they can develop new types of immunotherapies, new combinations of immunotherapies or new ways to use immunotherapy drugs that will achieve the desired response: allowing people with metastatic melanoma to live longer.
This news release describes a study that included 22 people, nine of whom were receiving an immunotherapy for the first time. Seven of those nine had “a positive response” to the drug combination. In two, the tumors disappeared completely. That’s a good thing. Would the patients have had the same response if they had received Keytruda alone? Maybe. Maybe not. There’s no way to know. The study wasn’t designed to test that. But this release could easily lead to news articles that make that case.
The experimental drug does not yet have a cost.
The news release does not state that Keytruda costs about $12,500 a month (it is given intravenously every three weeks) or $150,000 a year. It would have been relevant to discuss–since this new drug would be in addition to this very expensive treatment.
The news release describes the responses the patients in the study had to the treatment. But the benefits of this response are overstated in the following paragraph, which describes the results as “suggest[ing] that the combination of pembrolizumab and SD-101 could provide an alternative treatment for people with melanoma whose tumors have not responded or would be unlikely to respond to other therapies.”
The study was not designed to look at this and did not show this. It was a trial to test for safety and safest dosages. What were the safety results? Readers don’t find out.
This was a dose-escalation study that was conducted to determine the safest dose. This means the focus was symptoms and side effects. And the news release states that. Yet, none of the symptoms or side effects patients in the study experienced are described in the news release. This is a major deficiency of this release.
The news release describes the research as “early,” and provides clues to the size of the trial and what researchers were measuring. But this release needs to be clearer that any assessment of benefit may be entirely due to pembrolizumab (Keytruda) and it’s speculative to say this experimental combo shows promise at “beating advanced melanoma.” Nothing in this release supports this.
There is no disease mongering. Some statistics on how many people are diagnosed with metastatic melanoma every year would have been useful to include.
This information is included in the release.
The news release describes a phase Ib study using a combination of Keytruda an experimental agent. The presumed alternative is Keytruda alone, and that’s made relatively clear in the release. However, this was not a head-to-head trial of the two.
The news release makes clear that this is an experimental therapy that is not yet available. The release could have been improved by noting that Keytruda was approved by the FDA for use in metastatic melanoma in 2015.
The news release explains that injecting the drug into the metastatic sites to change the microenvironment is a new type of approach to improving response to Keytruda, though it could have provided more context.
Within the cancer research community, there is a lot of interest in the tumor microenvironment. As the National Cancer Institute explains, the microenvironment consists of the normal cells, molecules, and blood vessels found around the primary tumor and metastatic sites. This environment affects how the cancer cells grow and spread, so scientists think if they can change the environment they might be able to change how the tumor responds to cancer treatments. In this study, the researchers attempted to do that by injecting the experimental drug directly into the metastatic sites.
The headline “shows promise for beating advanced melanoma” is more wishful thinking than based on what the study was designed to do–and found. There is also no way of knowing if the “new treatment is more effective,” as the subheadline states. This was not a randomized trial. And there is absolutely no evidence that “it could help some people with advanced melanoma, an aggressive form of skin cancer, live longer.”