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Keytruda for bladder cancer: No independent scrutiny of Merck-reported results


3 Star


Merck says test shows Keytruda improves survival for bladder cancer patients

Our Review Summary

Cancer immunotherapy drugs are big business, and many news sites feverishly report whatever drug companies send out about the latest clinical trials–even before the data can be verified by outside parties. Such is the case with this story from Reuters, which reports on a phase 3 trial for Keytruda, an immunotherapy drug.

We liked that the story included absolute numbers on the performance of the drug–readers can read between the lines and see that survival improved by just three months. Yet the story skirted over some key details, notably how expensive this drug is.


Why This Matters

Reuters’ main audience may be investors, but this story will undoubtedly find its way to patients and loved ones. Some details that they care about–such as the incredibly steep price tag and potential for adverse effects–ideally would have been covered more thoroughly.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The cost of the drug is not discussed, and this is a significant oversight. As we’ve noted in another review of a story on Keytruda, “the cost is about $150,000 a year.”

Insurance coverage and high out-of-pocket costs are another issue that could have been addressed.

Does the story adequately quantify the benefits of the treatment/test/product/procedure?


The story does quantify the benefits of the intervention, and it does so in absolute terms.

“Merck said data from an open-label Phase 3 trial of 542 advanced bladder cancer patients showed median survival of 10.3 months for Keytruda patients and 7.4 months for patients given second-line chemotherapy. The study’s median follow-up was 18.5 months. After 18 months, 36 percent of Keytruda patients were alive, compared with 20.5 percent of chemotherapy patients, according to research published by ASCO. The study did not detect a difference in the length of time patients lived without their disease getting worse.”

This is sufficient to be satisfactory, but we do think more could be said about if this minimal time difference truly make an impact on patients’ lives, or not. Are the patients healthy enough to make meaningful use of the additional time they receive with treatment?

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

The story only tells us that:

Severe side effects were reported in 16.5 percent of the Keytruda patients, compared with nearly half of the chemotherapy group.

But what does severe mean? And how often did less severe side effects occur when patients were on Keytruda?

As we’ve discussed in 6 tips for writing about immunotherapy, there’s a tendency to underplay the harms of immunotherapy drugs.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story tells us this was an open-label phase 3 trial, with 542 patients. Lay readers (including bladder cancer patients) who come across this story may not know what either “open-label” or “phase 3 trial” means, so the story could have done more to explain.

But more importantly, the story should have explained that since this data is unpublished and not available for review by anyone, we have no way of knowing if what the drug company says is accurate. Nor can we see limitations to the trial, like a high drop-out rate.

Another thing that experts might look at is how many chemotherapy cycles each patient was able to receive, which would be critical to understanding how well the drug was tolerated.

Does the story commit disease-mongering?


This is a barely passing satisfactory. Some numbers on how common advanced bladder cancer is, and its mortality rate for standard treatment, would have been useful.

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

The story has no sources. It needed an independent voice to provide comment on what it means to see survival increase by only a handful of months, particularly for such an expensive treatment. Is the trade-off worth it? Will doctors readily prescribe this treatment?

Does the story compare the new approach with existing alternatives?


The story mentions that this drug was compared against standard chemotherapy.

Does the story establish the availability of the treatment/test/product/procedure?


The story makes it clear that the drug is not currently approved for this type of cancer, but is approved for other types.

Does the story establish the true novelty of the approach?


The implied novelty here is that this drug seemed to have demonstrated effectiveness in phase 3 trials, unlike a similar competitor’s drug, which had lackluster phase 3 results for the same purpose.

Does the story appear to rely solely or largely on a news release?


The story includes original background information on similar drugs from other competitors.

Total Score: 6 of 10 Satisfactory


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