CLINICAL TRIALS PROFILE FOR TRILACICLIB DIHYDROCHLORIDE

All Clinical Trials for Trilaciclib Dihydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02499770 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Etoposide and Carboplatin in Extensive Stage Small Cell Lung Cancer (SCLC)	Completed	G1 Therapeutics, Inc.	Phase 1/Phase 2	2015-06-26	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and etoposide in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 90 patients will be enrolled in the study; 20 patients in the Part 1 and 70 patients in the Part 2 portion.
NCT02514447 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy	Active, not recruiting	G1 Therapeutics, Inc.	Phase 1/Phase 2	2015-10-05	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consists of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. The open-label portion enrolled 32 patients and the randomized portion will enroll approximately 90 patients.
NCT02978716 ↗	Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)	Active, not recruiting	G1 Therapeutics, Inc.	Phase 2	2017-02-07	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for patients with metastatic triple negative breast cancer. The study is open-label and approximately 90 patients will be randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups: - Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=30) - Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=30) - Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=30) The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.
NCT03041311 ↗	Carboplatin, Etoposide, and Atezolizumab With or Without Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Extensive Stage Small Cell Lung Cancer (SCLC)	Active, not recruiting	G1 Therapeutics, Inc.	Phase 2	2017-04-07	This is a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing antitumor efficacy when administered with carboplatin, etoposide, and atezolizumab (E/P/A) therapy in first line treatment for patients with newly diagnosed extensive-stage SCLC. The study is a randomized, double-blinded, placebo-controlled design. The study will include 3 study phases: Screening Phase,Treatment Phase (induction part + maintenance part), and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit. Approximately, 100 patients will be enrolled in the study.

Clinical Trial Conditions for Trilaciclib Dihydrochloride

Condition Name

Condition Name for Trilaciclib Dihydrochloride
Intervention	Trials
Breast Cancer	3
Small Cell Lung Cancer	3
Extensive-stage Small-cell Lung Cancer	3
Myelosuppression Adult	2

Condition MeSH

Condition MeSH for Trilaciclib Dihydrochloride
Intervention	Trials
Lung Neoplasms	9
Breast Neoplasms	7
Small Cell Lung Carcinoma	7
Triple Negative Breast Neoplasms	5

Clinical Trial Locations for Trilaciclib Dihydrochloride

Trials by Country

Trials by Country for Trilaciclib Dihydrochloride
Location	Trials
United States	123
Spain	10
China	9
United Kingdom	6
Ukraine	6

Trials by US State

Trials by US State for Trilaciclib Dihydrochloride
Location	Trials
California	8
Texas	8
Florida	7
Missouri	6
Virginia	6

Clinical Trial Progress for Trilaciclib Dihydrochloride

Clinical Trial Phase

Clinical Trial Phase for Trilaciclib Dihydrochloride
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	13

Clinical Trial Status

Clinical Trial Status for Trilaciclib Dihydrochloride
Clinical Trial Phase	Trials
Recruiting	9
Not yet recruiting	7
Active, not recruiting	3

Clinical Trial Sponsors for Trilaciclib Dihydrochloride

Sponsor Name

Sponsor Name for Trilaciclib Dihydrochloride
Sponsor	Trials
G1 Therapeutics, Inc.	15
Jiangsu Simcere Pharmaceutical Co., Ltd.	2
Chengdu Seventh People's Hospital	1

Sponsor Type

Sponsor Type for Trilaciclib Dihydrochloride
Sponsor	Trials
Industry	18
Other	16

Trilaciclib Dihydrochloride: Clinical Trials Update, Market Analysis, and Projections

Introduction

Trilaciclib dihydrochloride, marketed as COSELA®, is a first-in-class comprehensive myeloprotection drug designed to mitigate chemotherapy-induced myelosuppression. Here, we will delve into the latest updates on its clinical trials, market analysis, and future projections.

Clinical Trials Update

Phase 2 and Phase 3 Trials in NSCLC

In the context of metastatic non-small cell lung cancer (NSCLC), trilaciclib is being evaluated in a Phase 2 randomized, double-blind, placebo-controlled trial. The PRESERVE 4 trial aims to assess the effect of trilaciclib administered prior to docetaxel on overall survival (OS) in patients receiving docetaxel in the 2nd or 3rd line setting. The trial involves approximately 146 patients and is expected to complete by the first quarter of 2024[1].

Phase 3 Trials in ES-SCLC

Trilaciclib has shown significant benefits in extensive-stage small cell lung cancer (ES-SCLC). The Phase 3 TRACES study demonstrated a clinically and statistically significant decrease in chemotherapy-induced myelosuppression, including reductions in days of severe neutropenia (DSN), severe neutropenia (SN), febrile neutropenia (FN), and Grade 3 or 4 hematologic toxicity. These results have been consistent across global studies, including those in China[2].

Phase 3 Trials in Metastatic Triple Negative Breast Cancer (mTNBC)

G1 Therapeutics is conducting the Phase 3 PRESERVE 2 trial to evaluate trilaciclib in combination with gemcitabine and carboplatin for the first-line treatment of mTNBC. The Independent Data Monitoring Committee (DMC) has recommended continuation of the trial to the final analysis, which is expected in the third quarter of 2024. Preliminary data suggest improved overall survival among patients receiving trilaciclib in combination with other therapies[3].

Efficacy and Safety

Myeloprotection

Trilaciclib has consistently shown its efficacy in reducing chemotherapy-induced myelosuppression. In ES-SCLC patients, it significantly decreased the incidence of severe neutropenia, febrile neutropenia, and other hematologic toxicities. This improvement in myeloprotection enhances patient tolerability to chemotherapy and reduces the need for supportive care measures such as granulocyte colony-stimulating factors (G-CSF)[2].

Overall Survival

While trilaciclib does not directly impact tumor growth, its ability to mitigate myelosuppression can indirectly improve overall survival by allowing patients to receive more consistent and effective chemotherapy regimens. Preliminary data from the ongoing Phase 2 trial in mTNBC suggest clinically meaningful improvements in overall survival when trilaciclib is combined with other anticancer therapies[3].

Market Analysis

Revenue Growth

G1 Therapeutics reported significant revenue growth from COSELA® in 2023, with net revenue of $46.3 million, representing a 48% increase over 2022. The fourth quarter of 2023 saw a 29% growth in net revenue to $13.9 million. The company has projected net COSELA revenue to be between $60 to $70 million for 2024[3].

Market Penetration

The strong revenue growth indicates increasing market penetration and acceptance of COSELA® among oncologists. The drug's unique position as a comprehensive myeloprotection agent addresses a significant need in the treatment of various cancers, including ES-SCLC, NSCLC, and mTNBC[3].

Cost Impact

A budget impact analysis revealed that the use of trilaciclib can lead to cost savings by reducing the management costs of myelosuppressive adverse events and the use of prophylactic G-CSF. Over a 5-year period, the adoption of trilaciclib was estimated to save $801,254, offsetting the acquisition cost of the drug[5].

Future Projections

Expanding Indications

Trilaciclib is being investigated in multiple ongoing and planned clinical trials across various cancer types, including metastatic colorectal cancer and triple negative breast cancer. The rapid development and approval process, as seen in China, suggest potential for swift expansion into new markets and indications[2].

Regulatory Approvals

The drug has already received approval from the US FDA for use in ES-SCLC and is recommended by the National Comprehensive Cancer Network (NCCN) guidelines. Future approvals in other indications, such as mTNBC, are anticipated based on the positive outcomes of ongoing trials[5].

Market Potential

Given the robust clinical data and growing market acceptance, trilaciclib is poised to capture a significant share of the myeloprotection market. The addressable market is substantial, with a large number of patients undergoing chemotherapy who could benefit from this innovative drug[3].

Key Takeaways

• Clinical Efficacy: Trilaciclib significantly reduces chemotherapy-induced myelosuppression, improving patient tolerability and potentially enhancing overall survival.
• Market Growth: Strong revenue growth and increasing market penetration highlight the drug's acceptance and potential.
• Cost Savings: Adoption of trilaciclib can lead to significant cost savings by reducing adverse event management and G-CSF use.
• Future Indications: Ongoing and planned trials suggest potential expansion into new cancer types and markets.

FAQs

What is trilaciclib dihydrochloride used for?

Trilaciclib dihydrochloride, marketed as COSELA®, is used to mitigate chemotherapy-induced myelosuppression in patients with various types of cancer, including extensive-stage small cell lung cancer (ES-SCLC) and metastatic non-small cell lung cancer (NSCLC).

What are the key benefits of trilaciclib?

The key benefits include a significant reduction in chemotherapy-induced myelosuppression, decreased incidence of severe neutropenia, febrile neutropenia, and other hematologic toxicities, and potential improvements in overall survival by enabling more consistent chemotherapy regimens.

Has trilaciclib received regulatory approvals?

Yes, trilaciclib has been approved by the US FDA for use in ES-SCLC and is recommended by the NCCN guidelines. It is also approved in China for similar indications.

What is the current market performance of COSELA®?

COSELA® has shown strong revenue growth, with a 48% increase in net revenue in 2023 compared to 2022, and the company projects continued growth in 2024.

Are there ongoing clinical trials for trilaciclib?

Yes, there are ongoing clinical trials evaluating trilaciclib in various cancer types, including metastatic triple negative breast cancer (mTNBC) and other indications.

Sources

1. Clinical Study Protocol G1T28-210: A Phase 2 Randomized, Double-blind, Clinical Trial of Trilaciclib versus Placebo in Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Treated with Docetaxel in the 2nd/3rd Line Setting (PRESERVE 4)[1].
2. Simcere News: COSELA® (Trilaciclib Hydrochloride for Injection) - The World's First Comprehensive Myeloprotection Drug[2].
3. GlobeNewswire: G1 Therapeutics Provides Fourth Quarter and Full Year 2023 Financial Results and Operational Highlights[3].
4. Patsnap: Trilaciclib Dihydrochloride - Drug Targets, Indications, Patents[4].
5. G1 Therapeutics: Budget Impact Analysis of Trilaciclib for Decreasing the Incidence of Chemotherapy-Induced Myelosuppression in ES-SCLC in the US[5].

Last updated: 2024-12-31