Nature: Comparison of PD1/PDL1 Immunotherapy Clinical Development Strategies

On January 6th, the team of researcher Chen Xiaoyuan of Tsinghua University published an article entitled "Comparing development strategies for PD1/PDL1-based immunotherapies" in the journal Nature Reviews Drug Discovery (IF=84.

The data in this article are mainly based on the NextPharma and PharmaGo databases of Pharma Cube.

The following is the translation of the original text of the paper:

Inhibitors targeting immune checkpoint PD1/PDL1 have revolutionized the clinical treatment of cancer

Overall, the most significant difference between global and Chinese PD1/PDL1 drug clinical development strategies lies in the selection of the first marketed indication

Figure 1 Timeline for the launch of PD1/PDL1 immune checkpoint inhibitors

In contrast, Chinese companies almost always prefer "rare" and "serious life-threatening" indications to achieve rapid approval for listing

Regardless of whether it is a Chinese or overseas company, the clinical development projects related to PD1/PDL1 drugs are extremely large

Figure 2 Development of PD1/PDL1 drug clinical trials

If we analyze the specific indications again, we can find that the local PD1/PDL1 drugs in China are more concentrated on tumors where it is easier to observe curative effects, such as lung cancer and liver cancer

Figure 3 Development trends of key clinical trials of PD1/PDL1 drugs in oncology in China and overseas

Considering the plethora of PD1/PDL1 drugs with highly identical development plans, the threshold for approval by global drug regulators also appears to be increasing

In China, CDE's recently released "Guidelines for Clinical Value-Oriented Clinical Research and Development of Antitumor Drugs" also emphasizes unmet clinical needs and clinical value

At present, a new generation of therapies aimed at surpassing PD1/PDL1 drugs are also being designed and developed

Figure 4 Types and distribution of PD1/PDL1-related drugs entering clinical development

PD1/PD-L1 joint development strategies that block multiple immunosuppressive signaling pathways (such as CTLA4, G3) or activate costimulatory signaling pathways (such as 4-1BB and OX40) have also become mainstream

Figure 5.

Some PD1/PDL1 products developed in China have also become first in class, such as the world's first subcutaneous injection of nvolimumab for the treatment of dMMR/MSI-H, and the development of Akeso Biopharmaceuticals for the treatment of cervical cancer The PD1 x CTLA4 bispecific antibody cadonilimab