Abstract A019: Longitudinal analysis of the landscape of cancer trials testing anti-PD-1/L1 monoclonal antibodies
Authors: Tang Jun , Pearce Laura , O'Donnell-Tormey Jill , Hubbard-Lucey Vanessa M. 
Published: February 2019

Abstract
Background: Monoclonal antibodies targeting PD-1 or PD-L1 (PDx) have revolutionized the standards of care for many types of cancer. As of June 2018, 5 anti-PDx agents have been approved by the FDA as monotherapy or part of combination therapy to treat 13 different cancer types. Since the first anti-PDx trial started in 2006, the anti-PDx clinical trial landscape has dramatically evolved. A current understanding of this expanding landscape by stakeholders in the immunotherapy clinical development enterprise will help to inform their prioritization of clinical trials and to support more efficient and effective evaluation of promising treatments. Methods: The Cancer Research Institute, a leading nonprofit organization dedicated to cancer immunotherapy research, has been tracking the progress in the immuno-oncology space over the past 5 years. Having analyzed the database at Clinicaltrials.gov, we were able to compare the available information regarding new interventional cancer trials evaluating PDx with that of all interventional cancer trials. We also compared the current PDx trial landscape with our previous PDx trial analysis conducted in Sept. 2017. Results: In the past decade, the new interventional cancer trials started per year have gradually increased from 2,294 in 2008 to 3,727 in 2017. However, during the same period of time, the number of new PDx trials per year increased from one in 2008 to 776 in 2017. Significantly, PDx trials accounted for 21% of all new interventional cancer trials in 2017. While the number of new trials increased, the average planned patient enrollment per PDx trial decreased from 476 patients in 2011 to 132 patients in 2017. When compared with our previous landscape analysis conducted in Sept. 2017, we found the number of active PDx trials (including both monotherapy and combination) increased from 1,502 as of Sept. 2017 to 2,011 as of Jun 2018, and the number of active PDx combination trials increased from 1,105 to 1,449 during the same time. Finally, in addition to PD-1 or PD-L1, other cancer targets evaluated by those PDx combination trials have expanded from 166 as of Sept. 2017 to 266 as of June 2018, and the planned patient enrollment of these combination trials expanded from 165,215 to 225,747 accordingly. Conclusion: Our landscape analyses show that the PDx trial space has been rapidly expanding, and the numbers of new trials started per year suggest no indication of slowing down in the near future. The 2,011 ongoing PDx trials are a testament to the field’s commitment to developing more effective immunotherapies that will build on the success of PDx checkpoint inhibitors. Care should be given, however, to ensure the trials being conducted are testing new PDx therapies or expanding the effectiveness of PDx therapies to new cancer types while avoiding the concentration of trials testing similar PDx therapies in a few identical cancer conditions.
Citation Format: Jun Tang, Laura Pearce, Jill O'Donnell-Tormey, Vanessa M. Hubbard-Lucey. Longitudinal analysis of the landscape of cancer trials testing anti-PD-1/L1 monoclonal antibodies [abstract]. In: Proceedings of the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival; Sept 30-Oct 3, 2018; New York, NY. Philadelphia (PA): AACR; Cancer Immunol Res 2019;7(2 Suppl):Abstract nr A019.