Immuno-oncology (I-O) is the treatment of cancer with immunotherapy, by using therapies to stimulate or suppress the body’s own immune system to fight cancer. Several distinct modalities of immunotherapy exist, including cytokines, vaccines, viruses, adoptive cell transfer, and checkpoint blockade using monoclonal antibodies. Overall, GlobalData expects innovative trial design and new combination drug approvals to drive immuno-oncology market growth.

Challenges in I-O trial design

• Perception of PD-L1 as a predictive biomarker
  
• Potential novel predictive biomarkers
  
• Clinically relevant endpoints for I-O studies
  
• Recruitment ease in I-O trials across tumor types
  
• Views on single arm studies to support approvals of I-O agents
  
• Expected use of I-O therapies approved from single arm studies
  

Future Use of Immunotherapy

• Patterns in unmet needs across tumor specialties: Given durable response is key unmet need across indications, differentiation of I-O therapies in terms of duration of response and improved survival measures continues to be crucial.
  
• Clinical potential for pipeline I-O therapies: Physicians’ broad excitement for pipeline I-O therapies rather than specific agents suggests that significant efforts in education will be important for developers to encourage positive perceptions and use of their therapies in an increasingly complex field.
  
• Optimal place for I-O therapies in treatment algorithms: Positioning of I-O therapies in 1L for variety of solid tumors is desired but likely to become more difficult as SoC evolves, while in hematological cancers I-O may replace salvage regimens, albeit for smaller 2L+ populations.