Our Review Summary
The release offers an overview of clinical trial results that were presented June 5 at the annual meeting of the American Society for Clinical Oncology (ASCO). The release notes that the drug nivolumab (which is marketed as Opdivo) shrunk the tumors of 24 percent (19 of 78) of patients with metastatic bladder cancer who received the drug.
Like a number of other drugs that have been significant advances in cancer treatment, the drug is an antibody that stimulates the immune system to attack cancer cells. It is already approved to treat a number of other cancers (advanced melanoma, lung, kidney, and Hodgkin’s lymphoma). Also of significance: Most of the patients had undergone at least two other courses of treatment. According to the quoted researcher, the 45% survival rate at one year is better than seen with other treatments for this cancer.
The release addresses many factors, but does not offer much detail about the study itself and doesn’t address cost — which is likely to be significant — or the fact the lead researcher served on an advisory board to the drug maker.
Why This Matters
HealthNewsReview.org reviewed a release about a different immunotherapy drug and bladder cancer in May 2016, but some of the points made in that review also apply here. The National Cancer Institute (NCI) estimates 76,960 new cases of bladder cancer and 16,390 deaths from this disease in 2016. This approval of a new drug for treating bladder cancer is part of a wider area of research into immunotherapy, in which drugs target mechanisms of the human immune response. This drug is an example of targeted chemotherapy which is becoming more important as treatments can be fine-tuned to the cancers of individual patients.
In patients with intractable cancers, immunotherapy appears to offer some new hope while also bringing sobering questions about affordability and disparity of access by income. These drugs can be extremely expensive — nivolumab was actually called out in an NEJM piece last year because of its cost. And the aggressive marketing of Opdivo directly to consumers also raises questions. Immunotherapy drugs hold promise, but they have limitations — including cost — and it’s important to highlight those limitations for both patients and healthcare providers.
Criteria
Not Satisfactory
The release doesn’t address costs at all, which is particularly problematic given that Opdivo is already on the market for use in treating other forms of cancer. In an NEJM piece published last year, one doctor that, when used for treating metastatic renal-cell cancer, nivolumab costs, “by my estimate, around $65,000 for Medicare beneficiaries and up to twice that for commercially insured patients.” Other estimates are that nivolumab treatment — again, for cancers other than bladder cancer — could cost more than $100,000 per patient. That is a huge factor in making treatment decisions, and needs to be addressed.
Satisfactory
The release does a pretty good job here, explaining that: “This Phase I/II clinical trial treated 78 patients: five (6.4 percent) had complete responses, 14 (18 percent) had partial responses, in which tumor burden shrinks by at least 30 percent, and 22 (28.2 percent) had stable disease. Thirty (38 percent) patients had disease progression.” Later, the release states that “At a median follow up of 213 days, 33.3 percent remained on treatment, and 45.6 percent of patients survived for at least one year, which [one doctor] noted ‘is better than anything we’ve seen in the past.'” The release also places analysis of survival in context by noting that “Overall survival will be analyzed in conjunction with the Phase II portion of this clinical trial, which provides nivolumab or a combination of nivolumab plus the immune checkpoint inhibitor ipilimumab.”
Satisfactory
The release states that “Treatment-related side effects included mainly low-grade fatigue, itching, elevated lipase, rash, nausea, joint pain and anemia. Grade 3 or 4 side effects occurred in 20.5 percent of patients. Two patients discontinued therapy because of adverse events related to the drug.” That’s enough to earn a satisfactory rating. However, it could have been better. The release says adverse effects “included mainly” manageable problems. But more than 20 percent of patients had “grade 3 or 4” side effects — and that is not trivial. The release would have been much stronger if it had offered some insight into those more severe effects, or even explained what “grade 3 or 4” effects means. Grade 3 effects, according to the National Cancer Institute, are “severe” — while grade 4 effects are “life-threatening or disabling.” That merits more discussion than it got.
Not Satisfactory
The release tells readers that 78 patients with metastatic bladder cancer were treated, and that the study has a “Phase II” component involving potential treatment with a second drug (ipilimumab). It doesn’t tell us anything about the patients — for instance their age or what previous treatments they’d received (information that can be found in the study abstract). We also don’t learn how often they were treated with nivolumab, how long the trial lasted, or what limitations should be considered when interpreting the study. In short, readers have more questions than answers about the study itself.
Satisfactory
No disease mongering here. The release might have added value by including a larger context on bladder cancer such as overall survival rates for it and how many people have to undergo treatment with one or more chemo regimens.
Not Satisfactory
The release notes that the clinical trial was funded by Bristol-Myers Squibb, which developed and markets both nivolumab and ipilimumab. However, the release doesn’t note that the lead author has served as a consultant to the Bristol-Myers Squibb Immuno-Oncology Network, among several others.
Satisfactory
The release notes that the only drug currently approved “for second-line treatment of metastatic bladder cancer” is a competing drug: atezolizumab. This would have been better if it had explained what “second-line treatment” means — since many readers are not going to know.
Not Satisfactory
The main reason that this is not satisfactory is that it is pretty confusing for non-expert readers. Nivolumab has not been approved by the FDA for use in treating metastatic bladder cancer. However, the release tells readers that nivolumab has been approved by the FDA for use in treating a variety of other cancers — and goes on to discuss survival rates for patients who take the drug (alone or in combination with ipilimumab). What does the FDA approval for treating other cancers have to do with the likelihood of nivolumab’s future availability for treating bladder cancer? That’s not clear, because the release doesn’t tell us.
Satisfactory
The release makes clear that nivolumab works by targeting so-called PD-1 proteins, allowing a patient’s immune system to target cancer cells — and that the drug appears to work on patients regardless of the presence of related PD-L1 ligands in the cancer. That’s enough to earn a satisfactory.
It also sets this therapy apart from others in its claim that:
“The response rate is better than we’ve seen for other potential second-line treatments and nivolumab is really well tolerated, which is important because bladder cancer patients are a fragile group after frontline treatment with platinum chemotherapy,” according to the lead investigator.
Not Satisfactory
The headline says “Nivolumab immunotherapy helps patients with advanced bladder cancer.” It would have been much more accurate to say “Nivolumab immunotherapy helps some patients with advanced bladder cancer” — many patients saw no benefit at all. The release also says that nivolumab is “really well-tolerated” — but goes on to note that more than 20 percent of patients had severe, life-threatening or disabling side effects. Perhaps what they meant to say was that nivolumab is “really well-tolerated compared to other treatment options.” But we can only go by the language that is actually used in the release, and it reached just a bit too far.
Total Score: 5 of 10 Satisfactory
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