RESEARCH TRIANGLE PARK, N.C. - G1 Therapeutics, Inc. (NASDAQ:GTHX), an oncology-focused biopharmaceutical company, has announced the presentation of positive Phase 2 clinical trial results for trilaciclib when used in combination with a TROP2 ADC (sacituzumab govitecan; SG) in patients with metastatic Triple Negative Breast Cancer (mTNBC). The data, which will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) meeting, indicates an improvement in median overall survival (OS) and a reduction in adverse events compared to historical data for the ADC alone.
The trial involved 30 patients with unresectable or metastatic TNBC who had undergone at least two prior treatments, with one in the metastatic setting. Results showed that the intent-to-treat (ITT (NYSE:ITT)) population receiving trilaciclib in combination with the ADC experienced an approximately four-month improvement in median OS (15.9 months vs. 12.1 months) compared to the ADC alone. Additionally, an exploratory analysis suggested a six-month improvement in median OS (17.9 months vs. 12.1 months) when compared to a similar patient population in the historical data.
Patients who had received prior anti-PD-(L)1 therapy without prior oral CDK4/6 inhibitor treatment saw prolonged OS. Furthermore, trilaciclib demonstrated a significant reduction in treatment-related adverse events such as diarrhea, neutropenia, anemia, and thrombocytopenia, which are commonly associated with the TROP2 ADC.
Chief Medical Officer of the Los Angeles Cancer Network, Dr. Lasika Seneviratne, highlighted the on-target benefit of trilaciclib in reducing side effects and noted the importance of these findings for further development in pivotal clinical trials. The Phase 2 trial's primary endpoint was progression-free survival (PFS), with key secondary endpoints including OS, myeloprotection, safety, and tolerability.
The promising results support further evaluation of trilaciclib in combination with SG or other ADCs. G1 Therapeutics aims to leverage these findings to design future pivotal combination trials. The company emphasizes the need for innovative treatments for TNBC, a subtype of breast cancer with fewer targeted therapies available.
InvestingPro Insights
G1 Therapeutics, Inc. (NASDAQ:GTHX) is generating buzz with its recent clinical trial results, and investors are keen to understand the company's financial health as it progresses. According to InvestingPro data, GTHX has a market capitalization of $213.83 million and has shown a robust revenue growth of 46.55% over the last twelve months as of Q1 2024. This growth is further highlighted by an impressive gross profit margin of 91.89% for the same period, indicating efficient management and a strong market position.
While the company's P/E ratio stands at -7.03, indicating that it is not currently profitable, the InvestingPro Tips suggest that analysts have revised their earnings upwards for the upcoming period, reflecting optimism in the company's future performance. Moreover, GTHX has demonstrated a high return over the last year with a 56.11% price total return, showcasing a significant recovery and potential investor confidence in its long-term prospects.
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