Slide 2: The field of immuno-oncology is still in its early stages, but new therapies and classes of agents have emerged in waves that heighten with each new development. Ipilimumab is an example of a new immunotherapy leading the charge with other PD-1–targeted agents that have been approved for the treatment of metastatic melanoma. In addition, chimeric antigen receptor T cells, cell-based therapies that condition a patient’s T cells to recognize a specific cancer, are poised to change the treatment armamentarium for hematologic cancers in the near future. Image credit: IMS Health European Thought Leadership.

Slide 3: Over the next 6 years, there is expected to be a surge in the number of combination targeted and immuno-oncology agents available on the market. In the first few years, breast and hematology combinations will predominate, and after 2018, combinations targeting solid tumors such as lung cancer and melanoma will drastically increase. Image credit: CenterWatch, FDA, clinicaltrials.gov, IMS R&D LifeCycle, IMSCG Analysis.

Slide 4: With new combination therapies, come new levels of complexity in terms of development and marketing for these new molecular entities, since most combinations come from two or more manufacturers. Not only can this complicate trial and commercialization strategies, but pricing flexibility and product promotion can also be affected. Currently, only four pharmaceutical companies (Roche, Bristol-Myers Squibb, AstraZeneca, and Janssen) are studying combinations of new molecular entities and an existing agent that are produced by a single manufacturer. Image credit: CenterWatch, FDA, clinicaltrials.gov, IMS R&D LifeCycle, IMSCG Analysis.

Slide 5: There are currently 100 active phase II and III trials for five mechanisms of action, which target 11 key tumors. These investigations include new molecular entities and new indications for drugs that are already on the market. Although many of the new molecular entities will not reach approval, those with proven activity (e.g., VEGF and PD/PD-1 inhibitors) will result in more indications. Image credit: IMS Health R&D Focus.

Slide 6: Non–small cell lung cancer (NSCLC), which accounts for 85% of all lung cancer cases, is an example of a disease in which patients are now being divided into groups defined by specific genetic mutations; however, those mutations can evolve and become resistant to therapy. Second- and third-generation targeted therapies for NSCLC offer the potential for multiple years of treatment with good quality of life. Immuno-oncology agents are also gaining traction for this indication; nivolumab has been recently approved and data indicate it is efficacious in non-squamous NSCLC as well. Image credit: IMS Health R&D Focus, clinicaltrials.gov company websites Dec. 2014.

Slide 7: Dividing patients into genetic subgroups is resulting in a new method of investigation, dubbed “basket studies.” These trials are meant to inform a broader clinical development program by pooling patients with different cancers, but well-established common molecular signatures into a single trial. Not only are these trials cost-effective, but they focus on overall response to the agent, and therefore can provide evidence for approval in rare cancers in which the genetic target is known but the unmet need for treatment is high. Image credit: IN VIVO, May 2014, Novel Clinical Trial Designs in Oncology: An Histology-Independent Approach.