text_1: Breakthrough study demonstrates survival advantage with immune checkpoint inhibitor for advanced kidney cancer patients
text_2: News releases from academic centers can fall victim to the hyperbole and excessive optimism often seen in the commercial realm. This release from MD Anderson Cancer Center avoids the worst excesses and we liked much of what was written, including the description of the study design and quantification of the survival benefit. But some important omissions are evident. We can perhaps forgive the release for not including a discussion of cost. But there were other significant deficiencies, including lack of a meaningful discussion on potential harms of the treatment, no mention of the study funding source, and no disclosure that the principal investigator (quoted extensively in the release) is a consultant to the manufacturer of nivolumab. These are important elements to help readers understand the true extent of this “breakthrough.”  Although a somewhat uncommon form of cancer, renal cell carcinoma (RCC) is an important topic. As is noted by the news release, a significant number of patients with the disease present with metastases making treatment difficult. Existing therapies are not ideal with only moderate improvements in survival. The demonstration of an immunotherapy for RCC that is more effective than existing treatments is encouraging. We should note that the “breakthrough designation” from the FDA  is “… intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible” (our emphasis added).