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The Clinical Accelerator team presents an unbiased, neutral, scientifically curated, and timely updated analysis of the immuno-oncology landscape based on information collected from numerous trusted and publicly available sources. We hope to inform the cancer research community through academic publications as it strives for efficiencies and innovation while avoiding duplication.

The clinical development of PD-1/PD-L1 agents is at the epicenter of immuno-oncology drug development. We created a timeline of FDA approvals to demonstrate the growth in this area.

 
Timeline of Anti-PD-1/L1 Antibody Approvals by the FDA.

 

In November 2018, we made a comprehensive analysis of the current clinical trial landscape of anti-PD-1/L1 immune checkpoint inhibitors. This report also compares the current landscape with the previous one surveyed by CRI one year ago. 2,250 clinical trials are evaluating PD-1/L1 immune checkpoint inhibitors, an increase of 748 trials over the past year. 1,716 trials are assessing regimens that combine PD-1/L1 immune checkpoints with other cancer therapies. 240 drug targets are being evaluated in the current landscape, 75 more targets compared to a year ago. Over 380,000 patient volunteers are required to fill all trials and there is 70% decrease of median patient recruitment rate of combination trials recently. For further detailed analysis, see our paper in Nature Reviews Drug Discovery.

2,250 active Pd-1/L1 trials in the current space, 748 more in a year
There are 2,250 active trials testing anti-PD-1/PD-L1 agents as of September 2018, compared with 1,502 trials in September 2017. An increase of 748 trials in one year.


PD-1/L1 combination trials 2017 vs 2018
614 more PD-1/PD-L1 combination trials added to this space in a year. In 2017, 1,102 trials testing 165 targets (including trials listed on clinicaltrials.gov but not yet launched). In 2018, 1,716 trials testing 240 targets.


Top 38 targets in the current PD-1/L1 combination trial space chart
The top 38 targets in the current PD-1/PD-L1 combination trial space. The 1,332 trials evaluating anti-PD-1/PD-L1 agents in combination with the top 38 targets (among the 1,716 combination trials testing a total of 240 targets) are shown here. We have selected those targets being evaluated in at least 6 trials. The number of active clinical trials that are testing drugs against the target are indicated in each bubble.


Evolution of PD-1/L1 trials by different cancer types
Evolution of PD-1/PD-L1 trials by different cancer types.


70%25 decrease of patient recruitment rate for PD-1/L1 combination trials in last 5 years
70% decrease of patient recruitment rate for PD-1/L1 combination trials. Many trials may face a shortage of patient volunteers as the median patient recruitment rate (RR; patients per site per month) for PD-1/PD-L1 combination trials has significantly decreased in the past 4 years.


Requirement of patient volunteers in PD-1/L1 trials
The requirement of patient volunteers of PD-1/L1 trials. 2,399 PD-1/PD-L1 trials have been started since 2006, with 2,250 being currently active. The combined sum of patient volunteers from all trials reach to 389,900. The new trials launched in 2017 alone planned to recruit a total 105,489 patients. The data cut-off was September 2018.


Recruitment rate of PD-1/L1 trials in different cancer types
Recruitment rate of PD-1/PD-L1 trials in different cancer types. The analysis included 533 PD-1/PD-L1 trials that had recruitment data on Citeline or Infosario. The current status of these trials are active but their recruitment status is ongoing or complete. Citeline is a clinical trial database from Pharma Intelligence, and Infosario is an analytical tool developed in IQVIA.


In our first academic publication (Annals of Oncology, December 2017), we made a comprehensive IO landscape analysis and highlighted the PD-1/PD-L1 landscape in particular. At the time of publication there were 164 agents targeting PD-1/L1, of which 50 were in clinical stages with five having already received FDA approval. These 50 agents were being evaluated in 1,502 studies, of which 1,105 were combination trials. Importantly, the analysis found that most of these trials are small, single-center, investigator-initiated trials. For further detailed analysis, see our paper in Annals of Oncology.


Data Sources: Cancer Research Institute (CRI) analytics derive from public data sources, including trade news, company press releases, academic publications, FDA announcements, clinicaltrials.gov, and conference reports, and proprietary data sources including, but not limited to, GlobalData. The analytical algorithm and visualizations are developed by and therefore sole property of Cancer Research Institute.

*Immunotherapy results may vary from patient to patient.

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