What are the trends and challenges of Cell Therapy?
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What are the trends and challenges of Cell Therapy?
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What are the trends and challenges of Cell Therapy?
Nature Review | Milestones, Trends, Advances and Challenges in Cell Therapy.
Since the FDA approved Kymriah in 2017, five more CAR-T therapies have been approved, the most recent being Carvykti, which was approved in February 2022.
The scope of the cell therapy field is still expanding, new technologies using other immune cells and stromal cells are still being investigated, and global R&D pipeline entries are increasing.
Despite the continuous expansion phase, the field still faces challenges.
For example, the targeting of solid tumors, the complexity of cell preparation, and obstacles to clinical implementation are all affecting the application of cell therapy in clinical practice.
In this article, an in-depth analysis of the cell therapy field, including related R&D pipelines and clinical trials, is presented.
And real-world data are also analyzed to describe some of the challenges of using cell therapy in clinical practice today.
01 Trends and rankings of treatment modalities
As of April 15, 2022, there were 2,756 cell therapy drugs in the global immuno-oncology pipeline, compared with 2,031 active drugs previously updated in 2021 . This represents 36% of that growth , with a slower R&D rate, compared to 43% in 2020-2021 and 61% in 2019-20 (Figure 1).
Figure 1 Changes in the number of cell therapies
Among various types of cell therapy, CAR-T cells continued to lead , growing 24% from last year , down from 38% growth from 2020 to 2021.
NK cell – based therapies have seen slow growth, up 55% last year (up 65% the year before), as shown in Figure 2.
Conversely, other types of cell therapy, including a variety of therapies other than T cells (such as DC cells, stem cells or myeloid cells) have exploded this year by 129% , compared to 37% growth from 2020 to 2021 .
In contrast, allogeneic therapy also increased dramatically over the past year (33%) compared to autologous therapy (23%), as shown in Figure 3
Figure 2 Comparing the pipeline of various cell therapies from 2020 to 2022
Figure 3 Comparison of allogeneic and autologous cell therapies at different stages of development from 2020 to 2021
02 Popular targets
The overall growth rate of cell therapy drugs is in line with the growth rate of target development , and both have slowed down. Target development has grown by 31% in the past year, and by 35% and 41% from 2019 to 2020 and 2020 to 2021, respectively.
CD19, BCMA and CD22 targets remain at the top of the list , as shown in Figure 4.
Some new targets are also increasing, such as GPRC5D (+200%), CLEC12A (+114%) and CD7 (+78%), although these are not the most commonly used targets. TAAs, HER2 and MSLN remain the most common targets in solid tumors .
The largest increases compared to 2021 were for CLDN18 (+400%), CD276 (+160%) and KRAS (+125%) . TAAs increased by 220%, making it a fast-growing target and the most popular target.
Figure 4 Popular targets for hematological and solid tumor cell therapy
03 Cell Therapy Clinical Trials
According to ClinicalTrials.gov data, there were nearly 1,800 cell therapy trials as of April 2022, a 33% increase from last year, a 43% increase from 2020 to 2021, and a 24% increase from 2019 to 2020. Figure 5.
This slowdown in growth is reflected in nearly all treatment modalities, including NK/NKT cell therapy.
There is also a growing number of trials using “other cell therapies” in clinical trials. As in previous years, most cell therapy trials are focused on addressing blood disorders.
However, clinical trials targeting solid tumors accounted for 43% of the overall and recorded the highest year-over-year increase (44% from 2021 to 2022). Figure 6.
Figure 5 Clinical trials from 2018 to 2022
Figure 6 Number of cell therapy trials for blood and solid tumors
04 The Real World CAR-T Therapy Scenario
To assess whether cell therapy pipeline growth trends are relevant to the clinical use of cell therapy, we analyzed 2019-2021 IQVIA proprietary medical and prescription claims data and assessed acceptance in clinical practice based on CPT, HCPCS, and ICD-10 codes Number of patients treated with CAR-T cells.
Overall, the use of CAR-T cell therapy in 2021 is similar to that in the second half of 2020, as shown in Figure 7.
Affected by the COVID-19 pandemic, the number of CAR-T cell therapy use in 2021 is consistent, and these data show that the use of CAR-T cell therapy in clinical practice lags behind the number of regulatory approvals, and also shows that its use in practice There are practical obstacles.
To understand these barriers, we obtained data collected from the IQVIA CAR-T Cell Surveillance Survey, which included community experts (n=100) and CAR-T cell center experts (n=50) regarding treatment, referral, and response to cell therapy Responses to perceptions (including availability, efficacy, and management of treatment).
Among community specialists, the top three reasons for not referring patients to a cell therapy center included patient health status (44%), patient cost (37%), and distance to the clinic (32%).
Figure 7 Number of CAR-T cell therapies used in US clinics from 2019 to 2021
By analyzing the facilities with cell therapy in the United States, most of them are located in densely populated areas such as the East and West Coasts.
This uneven distribution is also a barrier to referral. Overall, cost was the main barrier for patients to receive cell therapy (65%), followed by type of patient suitability (63%), and disease progression (54%).
In addition, waiting times for patients are also a significant reason for the slowdown in implementation.
Epilogue
The production of more targeted, safer or universal off-the-shelf CAR-T is imminent . Compared with hematological tumors, cell therapy for solid tumors needs to be overcome.
The survey found that the application in clinical practice does not match the rapid growth of the R&D pipeline. Several factors constrain, including patient eligibility, cost of treatment, location constraints, and patient burden.
In the future, academia, regulators, and industry must collaborate to place greater emphasis on cell therapy adoption, implementation, cost, and commercialization strategies so that this effective treatment pathway is accessible to a broad range of patients.
Reference:
https://www.nature.com/articles/d41573-022-00095-1
What are the trends and challenges of Cell Therapy?
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