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Trilaciclib Granted Fast Track Designation by the U.S. FDA for Use in Combination with Chemotherapy for the Treatment of TNBC

Release time:2021-07-30

On 19 June 2021, the U.S. Food and Drug Administration has granted Trilaciclib (COSELATM) the Fast Track Designation for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer (mTNBC). 

Trilaciclib is an innovative drug developed by Simcere’s partner G1 Therapeutics, INC. (Nasdaq: GTHX). Simcere is responsible for the development and commercialization of Trilaciclib in all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan). 

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill unmet medical needs. The purpose is to make important new drugs accessible to the patient earlier. A drug that receives Fast Track designation may be eligible for more frequent engagements with the FDA to discuss the drug’s clinical development plan and Accelerated Approval and Priority Review. It can also be granted Rolling Review in which the Company can submit completed sections of its New Drug Application (NDA) for FDA review, rather than waiting until every section of the NDA is completed before the entire application can be reviewed.

Currently, there is a significant unmet need for new treatment options among TNBC patients. The Fast Track Designation will help accelerate the development and regulatory review of Trilaciclib in this indication.

In a Phase II study, administering Trilaciclib prior to gemcitabine/carboplatin (GCb) has significantly improved overall survival (OS) compared with GCb alone among patients with mTNBC. The combined mOS of patients has increased from 12.6 months to 19.8 months (p<0.0001).

Trilaciclib is currently under evaluation of PRESERVE 2, a pivotal Phase 3, randomized, double-blind, placebo-controlled study (NCT04799249) initiated by G1, among patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC.

In June 2021, Simcere’s application to initiate clinical trial activity in China as part of PRESERVE 2 has been approved by the China National Medical Products Administration (NMPA). In addition, the phase III clinical trials in small cell lung cancer (SCLC) and metastatic colorectal cancer (mCRC) are also underway in China.

About Trilaciclib

Trilaciclib (COSELATM) is the first and only myeloprotection therapy to help decrease the incidence of chemotherapy-induced myelosuppression, which received the Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) in 2019 based on positive data in small cell lung cancer patients from three randomized Phase II clinical trials. On February 12, 2021, US FDA approved Trilaciclib to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). On March 25, 2021, trilaciclib has been added to two updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology: the Treatment Guidelines for Small Cell Lung Cancer and the Supportive Care Guidelines for Hematopoietic Growth Factors. 

In August 2020, Simcere has reached a cooperation agreement with G1 Therapeutics, INC. to be responsible for the development and commercialization of Trilaciclib in all indications in Greater China (Mainland China, Hong Kong, Macau and Taiwan).

About triple-negative breast cancer (TNBC)

TNBC is a cancer that tests negative for estrogen receptors (ER), progesterone receptors (PR), and excess HER2 protein, making up 15%~20% of all breast cancers. It is considered to be more aggressive than other types of breast cancer with poor prognosis.   

TNBC patients do not respond well to hormonal therapy or medicines that target HER2 protein receptors. Instead, chemotherapy remains the standard treatment even though it is limited by its toxicity and drives drug resistance in patients. In addition, myelosuppression which is an adverse event of chemotherapy damages a patient's immune system, putting patients in the precarious position of being unable to effectively mount immune based anti-cancer responses.

Therefore, there is an urgent demand to develop new treatments with improved anti-tumor efficacy without causing high toxicity, which is a major focus of exploration in the field of TNBC.

Forward Looking Statements

Information set forth in this press release contains forward-looking statements, which involve a number of known and unknown risks, uncertainties and assumptions. The forward-looking statements contained herein reflect the current judgment and views of Simcere Pharmaceutical Group Limited as of the date of this press release. Such forward-looking statements are neither promises nor guarantees but are subject to a variety of risks and uncertainties, many of which are beyond our control, or may not materialize, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements, whether as a result of new information, future events or otherwise, to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.