Article | July 17, 2017

Immunotherapy: Clinical Research Ups And Downs

Nick O’Brien, Marketing Copywriter, MEDRIO eClinical

Immunotherapy: Clinical Research Ups And Downs

We’re now nearing the home stretch of 2017, immunotherapy remains one of the biggest buzz generators in clinical research and drug development. This is no surprise – the industry seems to truly believe in the potential of immunotherapy to revolutionize cancer treatment, and sees in it a largely untapped market full of territory yet to be claimed. As a result, companies are diving enthusiastically into research and development of immunotherapy drugs, so much so that Bloomberg recently reported on the potential effect of market crowding on the prices of these drugs, when and if they arrive to market.

But most hype, of course, is eventually tempered by caveats and setbacks, and immunotherapy is no exception. While the approach has already saved many lives and shows promise in breaking down long-standing barriers in cancer treatment, there are still questions that we need further clinical research to answer before we can really start the celebration. Here’s a look at some of the encouraging aspects of the immunotherapy revolution, as well as some of the challenges that remain.

Success in the spotlight

It bears repeating that in many cases immunotherapy has, in fact, proved to be a game changer. Scientists have indeed saved lives by harnessing the body’s immune system to attack cancer cells it would otherwise miss. And the media has shown an affinity for shining a spotlight on many of these success stories. The Washington Post recently told the story of Stephanie Joho, a young woman whose life was saved by an immunotherapy clinical trial after doctors told her that her cancer had spun out of control – it later followed up the story with a patient advocacy piece written by Joho herself. The innovative treatment has even enjoyed some recent star power, as the successful immunotherapy treatment of former president Jimmy Carter in 2015 made headlines across the media.

Perhaps it’s the natural excitement of medical breakthroughs, or the cinematic value of underdog stories like Joho’s, that explain the media’s fondness of immunotherapy. Whatever the case, pharma companies and clinical researchers have reason to appreciate the buzz: Positive media coverage can lend positive publicity to the companies that make the drugs behind immunotherapy success stories, and cases like Joho’s demonstrate that cancer clinical trials can indeed save the lives of the patients enrolled in them, helping to overcome some of the notorious patient recruitment hurdles that these trials struggle with.

Remaining Challenges

As encouraging as all of this is, a handful of significant obstacles stand in the way of immunotherapy becoming the new gold standard in cancer treatment. Perhaps the most significant of these is the frustrating reality that success in immunotherapy is highly dependent on biomarkers. Joho’s success stems largely from the fact that her tumors had a genetic defect that made them highly vulnerable to immunotherapy – a defect found, as the Post article points out, in just four percent of all cancer types. And only two percent of lung cancers carry the specific mutation that can make them susceptible to the treatment. (1) Not only does this limit the potential of immunotherapy to treat deadly cancers, it severely limits enrollment eligibility criteria for clinical trials, creating headaches in patient recruitment.

Those who do meet the genetic preconditions for immunotherapy face challenges of their own. The treatment can cause cumbersome side-effects, and since it’s still in the early stages of development, questions remain about its long-term effect on the body.(2) On the administrative side, uncertainties as to how much of the treatment during a trial will be covered by a patient’s insurance can diminish enrollment.

That immunotherapy has generated such a frenzy of research and development even in spite of these challenges is an encouraging sign. After all, the caveats tempering the excitement over immunotherapy simply demonstrate the need for more clinical research to find ways to address those challenges, to answer the questions that remain about this groundbreaking development in oncology.

  1. Park, Alice; What If Your Immune System Could Be Taught To Kill Cancer?; Time Health; 23 March 2016
  2. Clark, Jackie; The Challenges of Research in Immunotherapy; Mesothelioma Cancer Alliance; 16 June 2017