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KRAS gene is one of the most common cancer driver genes in human cancer and is associated with many common cancers including lung cancer, colon cancer, pancreatic cancer, leukemia, etc.
Researchers have identified KRAS as a cancer decades ago important therapeutic targets
.
Usually, patients with KRAS mutations have no or very poor effect on targeted therapy drugs, and almost all targeted drugs have encountered waterloo in the face of KRAS gene mutations
.
Common EGFR mutation-positive lung cancer patients can achieve a 60% response rate with the EGFR-targeted therapy drug erlotinib, but for patients with KRAS mutations, the response rate drops sharply to less than 5%
Disappointingly, given the special structure of the KRAS protein, in the nearly 40 years since the discovery of this target, no targeted drug has been approved that directly targets KRAS mutations
.
Therefore, KRAS was once considered a non-drugable target
Amgen Sotorasib Approved to Break KRAS Undruggable
Amgen Sotorasib Approved to Break KRAS UndruggableAt the end of May 2021, Sotorasib, developed by Amgen, received accelerated approval from the FDA under the trade name Lumakras for the treatment of non-small cell lung cancer patients with KRAS G12C mutation who have received at least one systemic therapy
.
It is reported that this innovative drug can bind to KRAS G12C, locking the protein in an inactive state, preventing it from sending signals that drive uncontrolled cell growth
The FDA's marketing approval for sotorasib was based on a Phase II clinical trial called CodeBreaK 100
.
The trial results (NCT03600883) published in the internationally renowned medical journal "New England Journal of Medicine (NEJM)" showed that among 126 patients with KRAS G12C mutation, the objective response rate reached 37.
In January 2022, in addition to the United States, Sotorasib was approved for marketing in Japan and Europe successively for the treatment of KRAS G12C mutation-positive, unresectable, advanced and/or recurrent non-small cell lung cancer
.
BeiGene brings Sotorasib to the Chinese market
BeiGene brings Sotorasib to the Chinese marketIn November 2019, BeiGene and Amgen reached a global oncology strategic cooperation, involving the joint development of multiple drug therapies including Sotorasib
.
In July 2020, BeiGene submitted a clinical trial application for this drug in China, and it has been approved for clinical use; in mid-January 2021, the CDE official website showed that the KRAS G12C inhibitor AMG 510 ( Sotorasib) was included in the proposed breakthrough therapy category, and the proposed indication is patients with locally advanced or metastatic non-small cell lung cancer carrying KRAS p.
Overview of the development of KRAS-targeted drugs under research in China
Overview of the development of KRAS-targeted drugs under research in ChinaAccording to statistics, there are currently 24 KRAS-targeted drug research projects in China, involving 10 local pharmaceutical companies including Zai Lab, Innovent Bio, and Betta Pharmaceuticals.
Most of the research projects are in preclinical development.
stage
.
Among them, the fastest progress is Zai Lab's Adagrasib, which is in the phase III clinical stage.
The development indication is colorectal cancer.
This drug is an investigational, highly selective oral drug introduced by Zai Lab from Mirati Therapeutics.
Molecular KRASG12C inhibitors; Novartis' JDQ443, Innovent's GF-105, Jiakesi's JAB-21822, and Yifang Bio's D-1553 are all in Phase I/II clinical stage
.
Source: Southwest Securities
In addition, there are 4 drugs under research in Phase I clinical stage, including YL-15293 of Yingli Pharmaceutical, BPI-421286 of Betta Pharmaceuticals, GEC-255 of GeneAce Bio, and GH35 of Qinhao Pharmaceutical.
Indications are solid tumors
.
It is worth mentioning that the above-mentioned drugs under research in China all target KRAS G12C
