Immuno-modulating agents such as interleukin-2 and interferon have been used to treat some solid malignancies for years, but their use has generally been limited to cancers considered immunogenic – for example, melanoma and kidney cancers. Today, multiple immuno-oncology pathways are in development.
Promising approaches in immuno-oncology drug development include checkpoint inhibitors, antibody drug conjugates, autologous cellular immunotherapy, and oncolytic viruses. This webinar will explore each of these, along with challenges in researching these compounds and recommendations to improve your odds of success.
For instance, checkpoint inhibitors include monoclonal antibodies that target the cytotoxic T-lymphocyte associated antigen 4 (CTLA-4). Examples are ipilimumab – marketed as Yervoy – a drug that binds to the CTLA-4 on T cells and is indicated for treatment of unresectable metastatic melanoma, and programmed-death drugs such as pembrolizumab (Keytruda) that activate the immune system to attack tumors.
Clinical Trial Challenges
Response and efficacy of oncology agents is measured by RECIST (Response Evaluation Criteria in Solid Tumors), a set of published rules that define when cancer patients improve, stay the same, or worsen. This webinar will discuss why these criteria do not easily apply in immuno-oncology and how these realities gave rise to the immune-related response criteria – published rules that define when tumors respond, stabilize, or worsen.
Trial Planning Success Tips
Effective site training is essential when planning trials of immuno-oncology agents. In addition, combination studies should be planned early. This webinar will reveal how sufficient advance planning can reveal if a combination with a chemotherapy or other agent provides better efficacy without increasing toxicity.
Sound drug development requires a comprehensive understanding of the disease being treated. To design reliable clinical studies and achieve meaningful outcome measures, researchers must apply known etiology and thorough knowledge of the disease’s progression. For rare diseases, this information is often minimal at best: patient numbers are small and historical data is spread across treating physicians who operate around the world.
It’s essential that pharma companies, patient advocates, and other stakeholders use data on the natural history of these diseases to drive discussion and formulate drug development strategy. There are two prevalent data collection approaches: registry studies, which may include broad collection of defined data, and natural history studies, used for controlled, detailed collection of data that is subject to regulatory scrutiny.
Title: Expanding the Potential of Immuno-Oncology Therapies
Date: Tuesday, May 23, 2017
Time: 11am EDT (NA) / 4pm BST (UK) / 5pm CEST (EU-Central)
Duration: 60 minutes