“Along with PURPOSE-2, expected in late 2024 or early 2025, PURPOSE-1 forms the basis of our potential regulatory filing.”

In context

“ncology, the Phase 3 ENHANCE-3 trial evaluating magrolimab in front-line unfit AML has been discontinued based on a futility analysis and a higher observed incidence of Grade 5 serious adverse events. Following the discontinuation of ENHANCE and ENHANCE-2 last year, we do not plan further development of magrolimab in hematologic cancers. Wrapping up on clinical updates, I want to thank all those who were involved with EVOKE-01, OAKTREE and ENHANCE-3. Every trial adds important advancements in our understanding of the treatment of these diseases and will inform our future development plans. We look forward to sharing more on that in due course. Transitioning to our HIV program on Slide 21, we expect the Phase 3 readout of PURPOSE-1 evaluating lenacapavir for HIV prevention later this year. Along with PURPOSE-2, expected in late 2024 or early 2025, PURPOSE-1 forms the basis of our potential regulatory filing. We continue to target our first approval for lenacapavir in prevention in late 2025, potentially making lenacapavir the first twice-yearly dosing regimen available for PrEP. Looking at our HIV program more broadly, you can see we will be sharing at least nine updates this year across our next generation daily, weekly, three-monthly, and twice-yearly programs, all based on lenacapavir, our novel, first-in-class long-acting capsid inhibitor. We are excited to have over 75 presentations at CROI this year across Gilead-led and supported studies. Among them, some notable updates from our treatment pipeline include, encouraging data from our Phase 2 ARTISTRY-1 trial evaluating our lenacapavir and bictegravir once-daily oral. We are exploring this combination as a potential additional option for”