Anti-PD-1 drug research and development status
Indications / Development status
|Melanoma, advanced renal cell carcinoma, head and neck cancer, esophageal cancer, gastric cancer|
Lung cancer, esophageal cancer, gastric cancer
Keytruda® was recently approved by FDA to treat non-small cell lung cancer (NSCLC) with high PD-L1 expression (tumor proportion score [TPS] ≥50%) and no mutation in EEGFR or ALK gene.
The FDA granted an accelerated approval to PD-1 monoclonal antibody KEYTRUDA® (pembrolizumab) for use in combination with pemetrexed plus carboplatin as a frontline treatment for patients with metastatic or advanced nonsquamous non–small cell lung cancer (NSCLC), regardless of PD-L1 expression。
The FDA granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.
|AstraZeneca||FDA accelerated to approve Imfinzi (Durvalumab) (anti-PD-L1 formulation, code MEDI4736) for the treatment of metastatic urothelial carcinoma (UC).||Phase III, for the treatment of non-small cell lung cancer (NSCLC) and other cancers.|
|Novartis||PDR001||Register for Phase II in April 2015|
|Pidilizumab CureTech||Pidilizumab(Code: CT-011)|
Currently in phase Ⅱ clinical research phase., intended indications including large B-cell lymphoma, glioma and multiple myeloma.
|Domestic companies||PD-1 antibody research and development status|
China's first enterprise with PD-1 monoclonal antibody clinically approved
PD-1 monoclonal antibody BGB-A317 passed FDA‘s new drug research application review and was approved for clinical trials in the United States. On September 11, 2016, CFDA awarded drug clinical trial documents for its treatment of advanced solid tumors. It is currently in phase Ⅱ clinical trial.
SHR-1210 (PD-1 monoclonal antibody) for injection obtained drug clinical trial documents. It is currently in phase Ⅲ clinical trial.
|Innovent Biologics||PD-1 monoclonal antibody IBI308 was awarded the CFDA drug clinical trial documents, mainly for the treatment of advanced solid tumors.|
|Genor BioPharma||Anti-PD-1 monoclonal antibody (Jienuo McAb for injection) products clinical research applications were received|
Anti-PD-L1 drug research and development status
|Companies||PD-L1antibody research and development sta tus|
FDA accelerated to approve Tecentriq (Atezolizumab, anti-PD-L1 formulation, code MPDL3280A) for the treatment of metastatic urothelial bladder cancer (UBC).
FDA approved Imfinzi (Durvalumab) (anti-PD-L1 formulation, code MEDI4736) for the treatment of metastatic urothelial carcinoma (UC).
Anti PD-L1 humanized monoclonal antibody KL-A167 injection was accepted by CFDA.
Immune checkpoint drug research and development status
|Drug ||Company||Existing R & D status|
|CTLA-4||Ipilimumab (Yervoy)||Bristol-Myers Squibb||Approved by FDA in 2010|
|Tremelimumab||AstraZeneca||Phase III |
|OX40 ||MEDI6469 ||AstraZeneca||Phase II|
|LAG-3 ||IMP321 ||Immufact S A ||Phase III |
|LAG525 ||Novartis ||Phase I |
|Bristol-Myers Squibb ||Phase I |
|TIM-3 ||MGB453||Novartis||Preclinical |
|CD27 ||Varlimumab||Celldex Therapeutics||Phase II|
|4-1BB (CD137)||Urelumab (BMS-663513)||Bristol-Myers Squibb||Phase II|
|BTLA ||Preclinical |