Gilead Sciences’ Trodelvy has secured a significant win with its phase 3 trial results, demonstrating improved progression-free survival when combined with Keytruda for first-line triple-negative breast cancer (TNBC). The Ascent-04 trial, which targeted patients whose tumors express PD-L1, found that the combination of Trodelvy and Keytruda outperformed chemotherapy in prolonging time before cancer recurrence or death.
The results are a much-needed boost to Trodelvy, which faces stiff competition from rival TROP2-targeted ADCs. The drug’s success in late-stage bladder cancer has been inconsistent, with notable setbacks including a high-profile failure in non-small cell lung cancer and a withdrawn accelerated approval in bladder cancer.
Despite these challenges, Gilead argues that the trial’s findings further support Trodelvy’s potential as a new treatment option for first-line, PD-L1-positive metastatic TNBC. While overall survival data is not yet mature, early signs of improvement with the combination were observed.
The company expects to discuss the results with regulatory authorities and anticipates readouts from additional trials in 2024, including Ascent-03 and Ascent-05. Analysts predict Trodelvy could reach peak sales of $3.2 billion by 2030, citing a significant addressable patient population of approximately 10,000 across the US and EU5 countries.
The trial’s results mark a turning point for Gilead’s oncology business, which has been under scrutiny following several clinical setbacks. However, with Trodelvy’s potential as a game-changer in TNBC treatment, investors may look to the company once again.
Source: https://www.fiercepharma.com/pharma/gilead-trodelvy-keytruda-proposal-hits-goal-first-line-triple-negative-breast-cancer