Gilead Sciences, Inc.GILD

Gilead Sciences, Inc. focuses on oncology, with regulatory documents detailing findings for the drug Trodelvy in trial GS-US-592-6238 SG. In this trial, 181 (65.8%) participants experienced any Grade 3 or higher adverse events. Notable Grade 3 or higher adverse events included neutropenia in 118 (42.9%) participants, diarrhoea in 25 (9.1%) participants, and leukopenia in 20 (7.3%) participants. The median time to onset of severe (Grade 3 or higher) diarrhoea was 67 days. Serious infections secondary to neutropenia (Grade 3 or higher) occurred in 8 (2.9%) participants, with a median time to onset of 45 days and a median duration of 12 days. Fatal infections secondary to neutropenia were reported at 0.6% in the overall mBC pool.

Treatment-related adverse events included stomatitis in 38 (13.8%) participants, increased aspartate aminotransferase in 34 (12.4%) participants, lymphopenia in 31 (11.3%) participants, and abdominal pain in 28 (10.2%) participants. A total of 71 (25.8%) participants experienced any treatment-emergent serious adverse events. Deaths were reported, with 101 (36.7%) all deaths in trial GS-US-592-6238 SG. Deaths due to adverse events accounted for 9 (3.3%) of all deaths, while deaths due to progressive disease were 82 (29.8%). Within 30 days of the last dose, there were 10 (3.6%) total deaths, with 7 (2.5%) due to adverse events and 3 (1.1%) due to progressive disease. Within 60 days of the last dose, 25 (9.1%) total deaths occurred, with 8 (2.9%) due to adverse events and 17 (6.2%) due to progressive disease. AEs leading to death were observed in 7 (2.5%) participants.