Collaboration appears to be the order of the day in the healthcare industry, and the latest example of that comes in the form of an observational-study on multiple myeloma sponsored by Takeda Pharmaceutical.
The Japanese company announced Wednesday that is has begun to enroll patients in what will be the largest pharma company- sponsored observational study of this complex cancer. The study called INSIGHT-MM will enroll 5,000 patients over three years and has a goal to follow each patient for a minimum of five years. That long-term observation is expected to glean patterns in disease presentation, patient characteristics, treatment and outcomes.
“While collaborative studies are not the norm, we are seeing growing interest across the industry in data-sharing to accelerate the speed of research,” said Liviu Niculescu, vice president, global and U.S. oncology medical affairs, Takeda Oncology via email forwarded by a company representative. “INSIGHT-MM aims to collaborate rather than compete with other registries around the world, and it remains open for the multiple myeloma community to propose analysis and request data that has been collected during the study.”
The large datasets and open-source path undertaken should enhance the understanding of what experiences patients living with multiple myeloma endure outside the clinical trial world.
“Multiple myeloma is a complex disease with complex treatment approaches, and we need to be clever where we invest our resources,”Niculescu said. “This trial will help us do so by generating hypotheses to be tested in interventional trials.”
University of Arkansas for Medical Sciences, the University of California, San Diego and the University of Cincinnati Cancer Institute are the first three sites that have already enrolled patients.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
In addition to collecting data from the patient’s medical record and gathering information from routine office visits, the study will also use validated patient reported outcomes (PRO) questionnaires.
The total number of worldwide sites that are expected to participate is more than 150 in the following nations: United States, United Kingdom, Germany, Italy, Spain, Brazil, Israel, France, Belgium, Greece, Mexico, China, Taiwan, Colombia and Turkey.
Takeda has participated in other observational studies including the COMPASS study in partnership with the Multiple Myeloma Research Foundation and others.
The collaborative approach to crack the complex nut that is multiple myeloma and benefit patients of course is also smart business strategy. By 2023, the treatment market for multiple myeloma worldwide is expected to rise to an estimated $22.4 billion, from just 8.9 billion in 2014, according to market research firm GlobalData.
One of the blockbuster drugs that treat multiple myeloma is Velcade that the Takeda acquired when it purchased Cambridge, Massachusetts-based Millennium Pharmaceuticals in 2008 for $8.8 billion. Takeda also makes Ninlaro, which it bills as the first and only proteasome inhibitor taken in the form of a weekly oral pill and indicated as a second-line therapy for multiple myeloma patients. These drugs disrupt the process of proteasomes that break down proteins needed to kill cancer cells.
However, Velcade is coming off patent soon and Ninlaro reportedly has fallen short of sales expectation.
Photo Credit: Getty Images, mathisworks
