The inaugural edition of Premier Voices focuses on rare oncology drug development and takes a looks at: Using adaptive design to limit patient exposure to ineffective treatments and increase the overall likelihood of success Making the most of small and geographically dispersed patient populations Dealing with limitations such as a lack of defined biomarkers and baseline...
Hailed by many as the future of cancer therapy, immuno-oncology leverages and unleashes the body’s immune system to recognize and eliminate cancer cells. Immune checkpoint inhibitors have already revolutionized the treatment of certain solid tumors and hematologic malignancies by acting on pathways that cancers co-opt to evade immune recognition. Now, emerging therapies, such as chimeric...
DURHAM, N.C., APRIL 20, 2018 — A Premier Research oncology expert will discuss advances in the development of cancer drugs at Clinical Operations in Oncology Trials West Coast in Burlingame, California. Brian Huber, Executive Director for Oncology Strategic Development, will present Transforming the Oncology Drug Development Process on Tuesday, April 24, at 10 a.m. Mr....
Immuno-oncology continues to be an exciting frontier in the fight against cancer. Researchers continue to develop drugs that allow the body to weaponize its own immune system against the growth of new tumors. Most uses of immunotherapies have been limited to cancers, like those in the lungs or pancreas, that produce a strong immune response. In his article...
Immuno-oncology is a unique approach to cancer treatment that leverages the body’s immune system to help fight cancer. Immuno-modulating agents such as interleukin-2 (IL-2) and interferon (IFN) have been used in the treatment of some solid malignancies for years, but their use has generally been limited to cancers that are immunogenic, such as melanoma and...
Immuno-gene therapeutics are transforming the therapeutic landscape of hematological malignancies. The recent approvals of two chimeric antigen receptor (CAR) T-cell therapies—tisagenlecleucel (marketed as Kymriah™) and axicabtagene ciloleucel (marketed as Yescarta™)—mark the beginning of the next revolution in cancer treatment. However, along with demonstrated efficacy in hematologic malignancies, CAR T-cells have the capacity to elicit serious...
Over the past few years, there has been a dramatic increase in the use of genetically modified cells for cancer immunotherapy, including chimeric antigen receptor (CAR)-T cells, recombinant T-cell receptor T cells and genetically modified CD34+ cells for the treatment of hematological malignancies. Clinical trials of immuno-gene therapeutics are becoming increasingly common, and regulatory guidelines...
Unfortunately, not all oncology trials succeed. In fact, the phase success and likelihood of approval (LOA) rates for oncology are the lowest across major therapeutic areas. Although there are many reasons for these relatively poor success rates, issues determining dose, schedule, and regimen in early phase trials are among the most prominent. Why and Where...
Phase I and II trials may have different overall goals (i.e., demonstrating safety vs. efficacy), but the two both struggle with a major challenge in oncology study design: finding the right dose. Luckily, decades of data and innovations have given researchers the tools necessary to plan a successful dose-finding trial. Read on for a look...
Sponsors of emerging hematologic therapies – including gene transfer and gene editing, adoptive cellular, and antibody-drug conjugates – face a unique set of challenges in conducting early-phase, dose-finding studies. Key considerations for developing early-phase trials that can more accurately define the recommended dose and identify adverse events for emerging therapies include: Using dose-finding trial designs...