Gilead wins late-stage trial for breast cancer therapy amid concerns over lack of data
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Gilead Sciences (GILD
-0.8%) is trading lower on Monday even after the company announced that its Phase 3 trial for Trodelvy met the primary endpoint in certain patients with HR+/HER2- metastatic breast cancer, the most common type of breast cancer.
While the pharma giant said that the 543-patient TROPiCS-02 study met the primary endpoint with a statistically significant improvement in progression-free survival (PFS) compared to chemotherapy, it did not disclose the data to evaluate the response.
âDetailed results from TROPiCS-02 will be presented at an upcoming medical conference,â the company said.
Commenting on the announcement, Jefferies analyst Michael Yee noted: âThe debate by the Street was not necessarily if GILD could show a [statistically significant] benefit â¦but rather what magnitude of benefit Trodelvy can show.â
âAlthough top-line is technically positive and removes a worst-case scenario, Street may not get the clarity it needs for the stock to work until at least.â
However, the analyst expects Gilead (NASDAQ:GILD) to offer more data at the annual meeting of the American Society of Clinical Oncology, which is scheduled for June.
Trodelvy, which is already licensed in the U.S. for less common triple-negative breast cancer, generated $380M in sales for the company in 2021.
Ahead of the latest data readout, BMO Capital Markets downgraded Gilead (GILD) to Market Perform from Outperform, questioning the level of clinical significance expected in the TROPiCS-02 trial for the therapy.