The next phase of an important trial for metastatic triple-negative breast cancer patients is evaluating the effectiveness of trilaciclib combined with chemotherapy.
This effort, officially known as phase 3 of the PRESERVE 2 trial, has been recommended to continue by an independent data monitoring committee (IDMC) without any safety concerns or suggested changes to its design.
The final overall survival (OS) analysis for this study is expected in the third quarter of 2024. Trilaciclib, marketed under the name Cosela, is being assessed in combination with gemcitabine and carboplatin.
The confidence in trilaciclib’s potential is partly based on previous phase 2 study results, which showed a significant survival benefit that increased over time, especially as patients received subsequent therapies.
These results have provided a strong foundation for the final analysis of the phase 3 trial. The phase 2 trial had already presented promising data at the 2023 San Antonio Breast Cancer Symposium, showing that patients treated with trilaciclib, or Cosela, and chemotherapy had a median overall survival of 32.7 months compared to 12.8 months for those treated with chemotherapy alone.
This improvement in survival was consistent across different types of subsequent anticancer treatments received after the trial.
The phase 2 trial’s design involved randomly assigning patients to receive gemcitabine/carboplatin with or without trilaciclib, again, which will be known as Cosela.
The trial’s primary endpoints included the duration of severe neutropenia and the number of patients experiencing this condition. Secondary endpoints included overall survival and progression-free survival.
Eligible patients for the phase 2 trial were adults with hormone receptor-negative, HER2-negative TNBC who had an ECOG performance status of 0 or 1, adequate organ function, and a predicted life expectancy of at least 3 months.
The continuation of the PRESERVE 2 trial represents a hopeful step towards potentially offering a new treatment option for patients with this aggressive form of breast cancer.
The data from the phase 2 trial suggest that trilaciclib may improve survival outcomes by preserving immune system components critical for long-term immune surveillance, which could be beneficial for patients undergoing subsequent anticancer treatments.
