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Recent advances in drug research

2017-05-09 17:39:26.0

Anti-PD-1 drug research and development status


Foreign 
companies
Antibody

Indications   / Development status

BMS

Opdivo (Nivolumab)

Melanoma, advanced   renal cell carcinoma, head and neck cancer, esophageal cancer, gastric cancer

Merck                                                                                                                                     

Keytruda (Pembrolizumab)

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   companiesPD-1 antibody   research and development status
Junshibiosciences

China's first enterprise with PD-1 monoclonal   antibody clinically approved

BeiGene

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.

Hengrui Medicine

SHR-1210 (PD-1 monoclonal antibody) for injection obtained drug clinical trial documents. It is currently in phase Ⅲ clinical trial.

Innovent   BiologicsPD-1 monoclonal   antibody IBI308 was awarded the CFDA drug clinical trial documents, mainly   for the treatment of advanced solid tumors.
Genor BioPharmaAnti-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

Roche (Genentech)

FDA accelerated to approve Tecentriq (Atezolizumab, anti-PD-L1 formulation, code MPDL3280A) for the treatment of metastatic urothelial bladder cancer (UBC).

AstraZeneca

FDA approved Imfinzi (Durvalumab)  (anti-PD-L1 formulation, code MEDI4736) for the treatment of metastatic urothelial carcinoma (UC).

Merck KGaA

MSB-0010718CPhase IIIfor ovarian cancer, metastatic lung cancer, non-small cell lung cancer.

Cornerstone medicine

PD-L1 monoclonal antibody clinical trial applications were received by the CFDA

Kelun Pharmaceuticals

Anti PD-L1 humanized monoclonal antibody KL-A167 injection was accepted by CFDA.


Immune checkpoint drug research and development status


Target

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
RG7888
Roche
Phase I
LAG-3
IMP321
Immufact S A
Phase III
LAG525
Novartis
Phase I

BMS-986016

Bristol-Myers Squibb
Phase I
TIM-3
MGB453 Novartis Preclinical
CD27
Varlimumab
Celldex Therapeutics
Phase II
4-1BB (CD137)Urelumab (BMS-663513)
Bristol-Myers SquibbPhase II
PF-05082566Pfizer
Phase II
BTLA
Preclinical
TIGIT
Preclinical


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