Simcere cooperates with Boao Hengda to use Trilaciclib for the first time in clinical treatment

On June 2, 2021, Trilaciclib, a new bone marrow-protecting drug approved by the FDA as a breakthrough therapy, issued its first prescription in the Hainan Boao Lecheng Medical Pilot Area, and completed the first clinical administration.

Trilaciclib was approved for marketing in the United States in February 2021.
It is the world's first and currently only product that is administered prophylactically during chemotherapy to protect the bone marrow and immune system.
Simcere Pharmaceutical Co.
, Ltd.
and Boao Evergrande International Hospital introduced the drug this time.
It was approved by the Hainan Provincial Drug Administration to be used for the first clinical treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) in Boao Evergrande International Hospital.

Prior to this, Simcere and Trilaciclib's research and development company G1 Therapeutics reached a cooperation and obtained Trilaciclib's development and commercialization rights for all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan).

Clinical needs for bone marrow protection remain to be met

At present, the cornerstone of most tumor treatment programs is still chemotherapy, but the side effects of chemotherapy are more prominent.
Among them, chemotherapy induced myelosuppression (chemotherapy induced myelosuppression, CIM) is a common serious adverse reaction.

Bone marrow is the manufacturing center of various types of blood cells (red blood cells, white blood cells and platelets) in the human body.
Once the activity is inhibited, blood cells will be insufficient, which will lead to serious consequences such as anemia, infection, spontaneous bleeding, and even death of patients.

Bone marrow suppression not only reduces the patient's quality of life, but also leads to a reduction or delay in the administration of chemotherapy drugs, reducing the anti-tumor effect of chemotherapy.
Immune cell damage caused by chemotherapy also prevents the patient's immune system from responding effectively to the tumor.

For patients with extensive-stage small cell lung cancer, the problem of bone marrow suppression is particularly prominent.
Small cell lung cancer is the worst type of lung cancer [1].
The standard chemotherapy regimen for extensive-stage small cell lung cancer has a moderate to high risk of myelosuppression.
A considerable number of patients are over 65 years old and are more susceptible to the side effects of chemotherapy.

At present, the main clinical measures to cope with bone marrow suppression include the use of hematopoietic growth factors, blood transfusion (red blood cells, platelets), etc.
, but these interventions are lineage-specific and can only specifically act on a certain type of blood cells.
On the other hand, these measures themselves come with additional risks, which may cause the patient's hospitalization time to be extended and medical costs to increase.
And these are all interventions after the occurrence of CIM, which is a "passive response.
"

Is there a way to prevent CIM during chemotherapy without reducing the anti-tumor efficacy?

The first domestic prescription for preventive new drugs

Trilaciclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor developed by G1 Therapeutics.
It is the first drug designed to reduce chemotherapy-induced bone marrow suppression by protecting stem and progenitor cells (HSPC).
Trilaciclib provides the possibility for this new treatment model.

In terms of mechanism of action, Trilaciclib can temporarily maintain the G1 cell cycle arrest of HSPC in the bone marrow, protect cells from cytotoxic drugs, and improve the tumor immune microenvironment when combined with chemotherapy.
In 3 ES-SCLC clinical trials (G1T28-02, G1T28-05, G1T28-03), Trilaciclib can significantly improve the incidence and duration of severe neutropenia, and reduce the incidence of grade 3/4 anemia and thrombocytopenia The incidence rate of chemotherapy, the incidence of chemotherapy reduction, the incidence of granulocyte colony stimulating factor (G-CSF) administration, and the incidence of red blood cell transfusion from the 5th week, and the incidence of bone marrow suppression and blood cell reduction caused by complications such as severe infections, etc.
A considerable degree of improvement has been achieved in all clinical and laboratory indicators.

At present, Trilaciclib has carried out a number of clinical trials overseas, including triple negative breast cancer (TNBC), metastatic colorectal cancer (mCRC), etc.
In China, two phase III clinical trials of Trilaciclib have been approved for patients with extensive-stage SCLC treated with carboplatin combined with etoposide or topotecan, and patients with mCRC treated with FOLFOXIRI/bevacizumab.

This clinical application is not only an attempt of the product in the domestic patient population, but also will provide real world evidence for Trilaciclib to be used in more Chinese patients in the future.
(Sina Pharmaceutical News )

references:

[1] Zhou, S.
, Huang, Y.
, Zhao, Z.
, & Wang, L.
(2011).
Zhongguo fei ai za zhi = Chinese journal of lung cancer, 14(10), 819–824.

[2] Weiss et al.
, 2020 American Society of Clinical Oncology (ASCO), Abstract #384.