Gilead(US:GILD) ZACKSยท2025-06-02 14:41Core Insights - Gilead Sciences, Inc. announced positive data from the late-stage ASCENT-04/KEYNOTE-D19 study for its breast cancer drug Trodelvy, showing a 35% reduction in the risk of disease progression or death when combined with Merck's Keytruda compared to Keytruda and chemotherapy in first-line PD-L1+ metastatic triple-negative breast cancer (TNBC) [1][10] Study Details - The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized phase III trial evaluating Trodelvy in combination with Keytruda against chemotherapy plus Keytruda in patients with previously untreated, inoperable locally advanced or metastatic TNBC expressing PD-L1, enrolling 443 patients [5][12] - Patients were randomized to receive either Trodelvy plus Keytruda or chemotherapy plus Keytruda, with the chemotherapy regimen including gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel [6][10] - The primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), and safety [9][10] Efficacy Results - Trodelvy plus Keytruda demonstrated a median PFS of 11.2 months compared to 7.8 months with standard care, indicating a statistically significant improvement [8][10] - The combination therapy also showed a numerically higher overall response rate and a longer duration of response (DOR) [10] Safety Profile - The safety profile of Trodelvy plus Keytruda was consistent with the known safety profiles of both drugs [11] Future Prospects - Gilead aims to expand Trodelvy's label, as TNBC is the most aggressive type of breast cancer with limited first-line options for PD-L1-positive metastatic cases [12][14] - Gilead has ongoing phase III studies evaluating Trodelvy across various breast cancer types and other tumor types, indicating a broadening of its oncology portfolio [15][16] Market Performance - Gilead's shares have gained 20% year-to-date, contrasting with a 3.1% decline in the industry [4]