“We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year.”

In context

“acapavir, an investigational once-daily oral regimen for virally suppressed people with HIV. This is now under priority review, and we expect an FDA decision in August. Other upcoming HIV milestones include Phase 3 updates later this quarter from the ILLAND-1 and -2 studies evaluating a potential first once-weekly oral for virally suppressed people with HIV. We shared encouraging Phase 1 data at CROI in February for a long-acting integrase inhibitor GS-3242. Later this year, we plan to share additional data that support the combination of GS-3242 with lenacapavir as a potential twice-yearly injectable treatment regimen. The time frame for potential launch is between 2031 and 2033. In oncology, first quarter Trodelvy sales were up 37% year-over-year, reflecting growing demand for Trodelvy. We anticipate regulatory decisions on extending into first-line metastatic triple-negative breast cancer in the second half of this year. Ahead of these decisions, Trodelvy has already received NCCN category 1 recommendations across the first line and is the leading ABC and second-line metastatic TNBC treatment. We are also expecting Phase 3 updates from the EVOQUE-3 trial in first-line metastatic non-small cell lung cancer and the ASCENT GYN trial in second line-plus metastatic endometrial cancer in the second half of this year. The pending acquisition of Tubulus is another significant milestone in building Gilead Sciences, Inc.'s oncology franchise. The company brings a clinical-stage candidate, TUV-40, which we believe has the potential to be a leading ADC in ovarian cancer and a next-generation ADC platform with a promising early pipeline. At the upcoming ASCO meeting, we look forward to additional Phase 1 data on TUV-4”