A new cancer drug, Opdivo, is working so well that pharmaceutical giant Bristol-Myers Squibb announced Monday it is stopping a trial in lung cancer two years ahead of schedule.
The trial compared Opdivo to Docetaxel, a type of chemo used for patients whose cancers have recurred after treatment. The study, in 234 patients, was the largest trial of the drug in lung cancer.
“We as a lung cancer community are incredibly excited about the activity of immunotherapy in various aspects of the disease,” said Pasi Janne, director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute in Boston. “It’s a disease where we’re desperately looking for new therapies.”
Lung cancer kills more Americans than any other type of cancer, nearly 160,000 last year.
The new trial looked at a type of lung cancer called squamous cell non-small cell lung cancer, which accounts for about 20%-30% of lung cancers.
There have been no other recent treatment breakthroughs in squamous cancer, which most commonly occurs in smokers or former smokers, so this advance is particularly welcome, said Janne.
Janne, also a professor at Harvard Medical School, said more research is needed before lung cancer patients should be routinely treated with Opdivo, Keytruda or similar drugs.
“I think it’s a little premature to start treating people today,” he said, “but I don’t think we’re far away from that.”
In December, the Food and Drug Administration approved Opdivo to treat advanced melanoma, a type of skin cancer that used to be considered a death sentence.
Opdivo and others in its class work by removing a brake that cancer puts on the immune system. In some patients, just removing the brake is enough to allow the person’s immune system to fight and contain the cancer. For other patients, researchers expect other drugs will be needed, too.
In addition to melanoma and lung cancer, this brake-release approach has been shown effective in early trials against bladder, kidney, head and neck cancers, and some blood cancers.
“We are feeling more and more confident that we are on the cusp of a treatment revolution,” said Roger Perlmutter, president of Merck Research Laboratories, which has its own, similar drug called Keytruda.
Merck is also studying Keytruda in people with advanced lung cancer to better understand how they are responding to treatment, what determines how well a patient will respond, and how to get good results for more patients, Perlmutter said.
Existing treatments – chemotherapy, radiation, surgery and so-called targeted therapies – can help beat back tumors, but once cancer has spread, it almost always returns. Immune therapy drugs offer the possibility that the immune system will keep cancer in check indefinitely.
But there are still a lot of unanswered questions about immune therapy.
“It is early days for the successes of immune therapy,” said Mark Fishman, president of the Novartis Institutes for BioMedical Research, a research arm of drug company Novartis, which is taking a different approach to turning the immune system against cancer. “We’re looking right now through a small keyhole at a very very large room, and we really don’t know yet how big it will be.”
Bristol-Myers Squibb announced Jan. 11 that it is ending a clinical trial for the drug Opdivo against a specific (and common) form of lung cancer ahead of schedule, due to promising results. The company offered very (very) little data on the results, and this story highlights the limitations of reporting on a drug trial when there is very little information available about the drug trial. Although the story talks to several sources, it tells readers very little about the potential costs, quantifiable benefits, risks associated with the drug, or the quality of the evidence. The story also offers only a hazy quote about when the treatment will become available, which could be interpreted as later this year or some time next decade. Frankly, the story leaves a lot of very important questions unanswered, or offers only nebulous answers. And with many lung cancer patients, and their loved ones, on the lookout for news of new treatments, reporters need to be able to answer some of these questions before writing a story.
Lung cancer’s a killer. According to the CDC, lung cancer is the second most common cancer, and the leading cause of cancer deaths, for both men and women in the United States — causing almost 157,000 deaths in 2011 alone. It is also the leading cause of cancer deaths globally, according to the World Health Organization, which estimates that there were 1.59 million lung cancer deaths worldwide in 2012. The American Cancer Society estimates that between 25 and 30 percent of lung cancers are squamous non-small cell lung cancers — which is the type of cancer that was being treated in this phase III trial of Opdivo.
The story does not mention costs at all. Other media reports have quoted the company as saying it will charge an average of $12,500 a month for Opdivo.
The story says only that Opdivo “is working so well that pharmaceutical giant Bristol-Myers Squibb announced Monday it is stopping a trial in lung cancer two years ahead of schedule.” But “working well” doesn’t give readers any idea of the scope of potential benefits. The story also calls Opdivo a “breakthrough” — how we can we know that if we don’t know anything about what happened in this study? Even the relevant news release offered more information, stating that “the study met its endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm” (i.e., those patients receiving docetaxel). Even if Bristol-Myers Squibb chose not to release any numbers, it may still have been possible to find and discuss survival rates for squamous non-small cell lung cancer patients outside of the study who are treated with docetaxel. Failing that, the story could have noted the lack of quantifiable benefit information provided by Bristol-Myers Squibb.
The story does not mention any potential harms associated with Opdivo, despite the fact that the Bristol-Myers Squibb release notes a variety of possible adverse side effects (and that 41 percent of patients receiving Opdivo had adverse reactions). These possible side effects included immune-mediated pneumonitis (i.e., lung inflammation — including fatal cases), hypothyroidism, colitis, and hepatitis, among others.
There is really no evidence provided for which the quality could be evaluated. The entire story rests on “trust me” claims by Bristol Myers Squibb. The story notes the size of the study, but it’s not clear where that number came from, since Bristol-Myers Squibb’s statement cites a different number (234 patients in the story, 272 according to the company’s news release) — and that’s the only quantifiable study data in the story. One could argue that the dearth of data in the story is the fault of Bristol-Myers Squibb, which released precious little information about the study. But our position is that the journalist’s job is to be more than a stenographer for his or her sources.
The story points out that lung cancer is a scary disease — and it is. No disease mongering here.
Although the story quotes three different experts who comment on this area of cancer research, we would be hard-pressed to call any of them independent or unconflicted. The main source — Pasi Janne — is the director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, which recently entered into a partnership with Bristol Myers Squibb to explore cancer immunotherapy. The other two sources are with competing drug companies who are developing their own cancer immunotherapies. Had any of these sources been able to give some type of evaluation of the study that’s supposedly being reported on, we might have rated this satisfactory. A surefire way to earn a satisfactory would have been to quote an independent expert oncologist with no horse in this race.
The story notes that “chemotherapy, radiation, surgery and so-called targeted therapies – can help beat back tumors, but once cancer has spread, it almost always returns.” We’ll rate this sufficient for a satisfactory, although it would have been useful to have some actual data as to how Opdivo compares to these other approaches.
The story notes that Opdivo is approved to treat advanced melanoma. And Pasi Janne, a professor at Harvard Medical School and director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, says more research is needed before “patients should be routinely treated with Opdivo” and that “it’s a little premature to start treating people today…but I don’t think we’re far away from that.” That’s all very useful context. However, it’s not clear at the end of the day what any of this means for patients. Could Opdivo, given it’s melanoma approval, now be used off-label to treat lung cancer? Should patients expect this treatment to become available in six months? Six years? Ten years? The story also doesn’t note that the study being halted by Bristol-Myers Squibb is a Phase III trial.
The story notes that Opdivo is one of a class of several drugs that work through a similar mechanism.The story also establishes what is novel when it notes that “There have been no other recent treatment breakthroughs in squamous cancer … so this advance is particularly welcome.” While we don’t countenance the use of the word “breakthrough” based on a company press release that contains almost no useful information, we won’t ding the story for hyping the novelty of this drug. It’s clear that this is one of several drugs in development being tested on different types of cancer.
Don’t get us wrong — it’s clear that the main “news” here is based entirely on a company news release. However, since the story includes context from multiple sources and finds background information not included in the Bristol-Myers Squibb materials, it meets our standard for this criterion. That’s why we’re rating it satisfactory.