Gilead Voluntarily Withdraws Urothelial Cancer Drug in US

Gilead Sciences, Inc. (Nasdaq: GILD) has announced its decision to voluntarily withdraw Trodelvy (sacituzumab govitecan-hziy) from the US market for the treatment of locally advanced or metastatic urothelial cancer (mUC). This move comes after the drug failed to demonstrate a statistically significant survival benefit in a phase 3 trial, the TROPiCS-04 study.

The TROPiCS-04 study evaluated Trodelvy against single-agent chemotherapy in patients with mUC who had previously received platinum-containing chemotherapy and anti-PD-(L)1 therapy. Although a numerical improvement in overall survival (OS) was observed, it was not statistically significant. Furthermore, the study linked Trodelvy to a higher number of deaths due to adverse events, primarily related to neutropenic complications, including infection.

Gilead's decision to withdraw Trodelvy from the US market for mUC treatment is expected to have significant financial implications. The drug's accelerated approval in 2021 was based on a single-arm study showing a response rate of 27.7% in patients following chemo and PD-1/L1 therapies. However, the recent trial results suggest that Trodelvy may not provide the expected clinical benefit, potentially leading to impairment charges similar to those incurred in 2022 and 2023.

The withdrawal of Trodelvy in the US will also impact Gilead's competitive position in the ADC market. The company is facing competition from Merck & Co. and the partnership between AstraZeneca and Daiichi Sankyo, both of which have TROP2 ADCs in development. Gilead's setback in bladder cancer contrasts with the success of Pfizer and Astellas' Nectin-4 ADC Padcev, which demonstrated a resounding overall survival win in first-line bladder cancer.

Gilead will need to reassess its oncology revenue goals and drug development strategies in light of this withdrawal. The company had previously aimed to have a third of its revenue from oncology by 2030. To mitigate the impact of this withdrawal, Gilead may need to focus on other promising oncology candidates in its pipeline and explore strategic partnerships or acquisitions to bolster its competitive position.

Investors are likely to react negatively to this news, as it signals a potential loss of revenue and impairment charges for Gilead. The long-term effects on Gilead's stock price and overall market valuation will depend on the company's ability to adapt its strategies and maintain its market position in the oncology sector.