Gilead Sciences Eyes HIV, Oncology Catalysts as Pipeline Enters Execution Mode

Gilead Sciences is expanding prevention options across daily, weekly and long-acting dosing formats, with a regulatory decision on weekly oral lenacapavir expected in the first quarter of next year. The company is also developing a six-month HIV treatment combination using lenacapavir and GS-3242. Gilead expects a potential year-end approval decision for anito-cel in heavily pretreated multiple myeloma and is pursuing earlier-line studies. Its Tubulis acquisition added TUB-040, which showed a 60% objective response rate in platinum-resistant ovarian cancer and could move toward Phase III testing. Pipeline execution and prioritization are now the focus: Gilead expects important second-half readouts for inflammation candidates emvistegrast and edecesertib, while prioritizing programs with the strongest clinical and commercial potential across virology, oncology and immunology.

Gilead Sciences Chief Medical Officer Dietmar Berger outlined the company’s priorities across HIV, oncology and inflammation, describing a portfolio that has expanded through internal development and acquisitions and is now entering a period of prioritization and execution. Berger said Gilead’s management team began pursuing diversification seven years ago while maintaining its virology franchise. The company is seeking to advance treatment and prevention options for HIV while building broader oncology and inflammatory disease businesses.

In HIV prevention, Berger said Gilead is pursuing multiple dosing formats to address differing patient preferences. These include daily oral DESCOVY, once-every-six-month subcutaneous Yeztugo, a submitted once-weekly oral lenacapavir option, and a clinical trial evaluating an annual intramuscular Yeztugo injection. “It is really about optionality,” Berger said, noting that some patients prefer long-acting injections while others do not want injections at all.

Gilead expects a decision on weekly oral lenacapavir during the first quarter of next year, according to Berger. The submission is based on model-informed drug development, pharmacokinetic data and Gilead’s experience with an oral bridging therapy used when patients miss a Yeztugo injection. Berger said the company has held extensive discussions with the FDA and does not view the filing as riskier than other submissions.

For HIV treatment, Gilead is developing a combination of lenacapavir and its long-acting integrase inhibitor, GS-3242, with a goal of delivering treatment every six months. Berger said the company knows GS-3242 can provide coverage for four months and is studying higher doses to support a longer interval. Gilead expects to know more by the end of the year and plans to advance the combination into Phase II studies.

Berger highlighted the addition of anito-cel through Gilead’s acquisition of Arcellx. The company is seeking approval for anito-cel in fourth-line-plus multiple myeloma toward the end of the year and is studying the CAR-T therapy in second- through fourth-line treatment settings, with earlier-line studies being prepared. He said the therapy’s ...