“Be bold and think differently about novel approaches – collaborative science, data sharing in pre-competitive areas, and urgency in advancing science!” “The exciting part about immunotherapy is the ongoing explosion of new therapies and treatments.” –Dr. Theresa LaVallee, Parker Institute for Cancer Immunotherapy and “Emerging Therapeutics Track Chair

PMWC sat down with Dr. Theresa LaVallee, Vice President of Translational Medicine and Regulatory Affairs at the Parker Institute for Cancer Immunotherapy, to discuss the recent developments in immunotherapy and their impact on individualized healthcare. Find the full interview on our blog post. Following are some excerpts from the interview.

“There are lots of ways immunotherapy is disrupting the way that we approach cancer treatment.”
One of last year’s approvals was a tumor agnostic biomarker which means the treatment is based on the molecular feature and not based on the anatomical location of the tumor. That is a first! The real challenge is figuring out whom to treat and with what agents. There are CAR-T based therapies that cure some people, PD-1 or PD-L1 targeted antibodies that cure some people, or CTLA-4 targeted antibodies that cure some people, but it is still a minority of people that are cured. So, whether to treat with a single agent versus a combination, or which therapeutic modality to give a cancer patient is a question that is not simple for a personalized health care approach.

“I believe, you have to look at the total cost of care and then the survival benefit that is afforded. Only that way can we really figure out the economics of it.” Figuring out how we could test patients with a multi-parameter test or an algorithm that could define who to treat with what agent(s) is the biggest challenge that we need to overcome. I believe, it is going to take some creative approaches to achieve this. Furthermore, if the tests have multiple analytes to be screened for, that will add to the cost side of the equation. Ultimately, the people who you treat should see a long-term benefit, and while we often hear the complaints about how expensive these agents are, some of these patients who are coming on these trials have already had seven lines of treatment. While the individual cost of one of those lines of therapy may not have been large, when you multiply it by seven, it is a real number.

PMWC 2020 Silicon Valley (Jan. 21-24) has many exciting sessions that focus on various aspects of immunotherapy and emerging therapeutics in Track 1, see below:

• CAR-T Cell Therapies
  • Next-generation CAR-T
  • Toxicity Management
  • CAR-T in solid tumors
  • Reimbursement Strategies
• Cancer Neoantigen Vaccines
  • Improving tumor targeting, Novel shared targets, Delivery platforms
  • Strategies to reduce toxicity
  • Clinical Management
• The Gut Microbiome
  • Clinical applications of microbiome in cancer
  • Microbiome approaches to drugs
  • Metabolism and Microbiome
• Tumor Microenvironment
  • Imaging technologies to assess the TME
  • Innate Immune Suppression
  • Interactions between tumor, the immune system and stroma
  • Influence of the TME in clinical modalities
• Improving Response to Checkpoint Blockade Therapies
  • Defining PD1 resistance for clinical studies
  • Trial selection
  • PD1 resistogram
  • Blood based biomarkers
• The FDA Perspective
• The VC Perspective and Investment Strategies

In addition, PMWC 2020 Showcases provides a platform for funded, emerging companies to present their innovative new technologies that intend to disrupt healthcare. Email [email protected] to apply.

Speeding Investigational Cancer Drugs for Patients – A panel chaired by Track 1 Chair Theresa LaVallee
Immunotherapy drugs have resulted in multiple firsts including a large number of accelerated approvals and new ways of classifying biomarkers. Recent articles questioned the validity of current FDA programs for rapid cancer drug approval, suggesting that they may be flawed. This panel will review FDA’s Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review programs, why the programs were created, how they address the needs and wishes of patients and families, and some of the points that the FDA failed to consider.
Panelists:

• Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, FDA
• Richard Schilsky, M.D., Senior VP and CMO, American Society of Clinical Oncology
• Ramy Ibrahim, M.D., CMO and VP, Clinical Development, Parker Institute