G1 Therapeutics trilaciclib cuts adverse events linked to Trodelvy in breast cancer patients
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G1 Therapeutics (NASDAQ:GTHX) said interim data from an ongoing phase 2 trial confirmed benefit of trilaciclib in reducing adverse events related to Gilead's (GILD) antibody drug conjugate (ADC) Trodelvy for breast cancer.
The data was from 30 patients enrolled in the trial of trilaciclib given prior to the ADC sacituzumab govitecan-hziy (Trodelvy) in patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The company said data showed on-target effect of trilaciclib to reduce rates of multiple adverse events by over 50%, compared to previously published Trodelvy single agent safety profile from the ASCENT trial, including neutropenia, anemia, and diarrhea.
Treatment-related adverse events (TRAE) of any grade related to any study drug were reported in 76.7% of patients, the most common were fatigue, alopecia, nausea, and diarrhea, the company added.
Initial data showed that objective response rate (ORR) is higher in patients with PD-L1(+) mTNBC (confirmed ORR=35.3%) relative to the overall study population (confirmed ORR=25.0%).
The median progression free survival (mPFS) with trilaciclib plus Trodelvy was 4.1 months, according to the company.
G1 said that prior data from the ASCENT study have shown a 34.9% ORR in the overall study group, and that patients pretreated with PD-(L)1 therapy show lower initial responses to Trodelvy (28.4% in pretreated patients versus 37.5% in untreated patients) and a lower mPFS compared to the overall population (4.2 months pretreated patients versus 5.6 months in untreated patients).
"It is too early to determine the efficacy of trilaciclib prior to sacituzumab in this patient population. However, early indications suggest a higher response rate in patients with PD-L1 positive tumors, which commonly have an immune inflamed tumor microenvironment and are thus more likely to respond early to immunotherapies," said G1's Chief Medical Officer Raj Malik.
The company expects overall survival data in Q1 2024.
GTHX +0.68% to $2.97 premarket May 10