Gilead Sciences Highlights Trodelvy Lung Data, Long-Acting HIV Pipeline at RBC Conference

Key Points

• Trodelvy is a key near-term catalyst for Gilead, with management highlighting upcoming data in first-line PD-L1-high non-small cell lung cancer and hoping for a meaningful progression-free survival benefit. The company also expects a potential approval in first-line triple-negative breast cancer later this year after positive ASCENT-03 and ASCENT-4 results.
• Gilead is expanding its oncology pipeline through the Tubulis ADC platform and anito-cel in multiple myeloma. Berger highlighted encouraging early efficacy and tolerability data for Tubulis’ TUB-040, while saying anito-cel is moving toward regulatory discussions and earlier-line myeloma studies.
• Long-acting HIV prevention and treatment remain central to Gilead’s strategy, including twice-yearly YEZTUGO, a once-yearly injectable in Phase 3, and weekly oral treatment combinations. The company also plans to share data later this quarter on islatravir plus lenacapavir and is pursuing even longer-acting injectable options.

Gilead Sciences NASDAQ: GILD Chief Medical Officer Dietmar Berger outlined several upcoming clinical and regulatory priorities across oncology, inflammation and HIV during a discussion with RBC Capital Markets senior biotech analyst Brian Abrahams.

Berger said Gilead is focused on advancing Trodelvy, its TROP2 antibody-drug conjugate, into additional tumor types and earlier lines of therapy, while also building out newer programs in cell therapy, inflammatory disease and long-acting HIV prevention and treatment.

Trodelvy Lung Cancer Data in Focus

Abrahams began by asking about EVOKE-03, Gilead’s study of Trodelvy in first-line PD-L1-high non-small cell lung cancer. Berger described the trial design as straightforward, with Trodelvy added to pembrolizumab, which he characterized as the standard of care.

Berger said Gilead is looking for a “significant PFS benefit” in the early analysis. He noted that progression-free survival is expected to be mature, while overall survival will be earlier and followed over time.

“If the study is positive, this would be the first time that you really see meaningful benefit of a combination in this setting on top of pembrolizumab,” Berger said.

He also pointed to Trodelvy’s recent positive data in first-line triple-negative breast cancer from the ASCENT-03 and ASCENT-4 studies, saying Gilead hopes for approval in that setting later this year. Berger said Trodelvy use has increased 37% year over year, which he attributed to physician comfort with the drug and confidence in its efficacy.

ADC Strategy Expands With Tubulis Asset

Berger also discussed Gilead’s interest in Tubulis, following Abrahams’ question about the company and updated data expected at ASCO. Berger said Gilead was attracted both to the company’s lead molecule, TUB-040, and to its differentiated antibody-drug conjugate platform.

He described Tubulis’ P5 and Alco5 platforms as novel linker and payload technologies. According to Berger, the P5 platform enables stable linkage intended to reduce systemic toxicities, while Alco5 supports combinations with different payloads.

Berger said Gilead had worked with Tubulis for about two years before the transaction and had developed familiarity with the platform. He cited data presented at ESMO 2025 for TUB-040, a NaPi2b-directed ADC in platinum-resistant ovarian cancer, including an objective response rate of roughly 50% to 60% and a disease control rate of about 90% in approximately 50 patients.

He compared that with current standard-of-care treatment with bevacizumab and chemotherapy, which he said produces objective response rates of roughly 25% to 30%. Berger also highlighted what he called a favorable tolerability profile, saying Gilead did not see major toxicities such as neurotoxicity, eye toxicity or intestinal toxicity.

Anito-cel Program Moves Toward Earlier Myeloma Settings

In multiple myeloma, Berger said Gilead is confident in the differentiation of anito-cel, a BCMA CAR T therapy. He said the company gained full rights through its acquisition of Arcellx, including anito-cel and the D-Domain binder platform.

Berger said the strongest early efficacy indicator for anito-cel is measurable residual disease, or MRD, which he described as a predictive parameter for long-term outcomes. “The MRD data for anito-cel are just better than anything that’s out there,” he said.

He also emphasized safety, saying Gilead has not seen severe longer-term neurotoxicities such as Parkinsonism or Guillain-Barré syndrome, nor enterocolitis effects seen with some CAR T approaches in myeloma.

Berger said the iMMagine-1 study in fourth-line-plus myeloma is under discussion with regulators, with a potential approval toward the end of this year. The iMMagine-3 study is evaluating anito-cel in second- to fourth-line patients. He added that Gilead is already planning studies in newly diagnosed myeloma, including both transplant-eligible and transplant-ineligible populations.

Inflammation Portfolio Includes Oral IBD Candidate

Berger said Gilead’s inflammation and immunology portfolio is beginning to mature alongside its virology and oncology businesses. He said the company currently has more than 10 molecules in inflammation, including three in Phase 2.

One of those is GS-1427, an oral alpha-4 beta-7 inhibitor being studied for inflammatory bowel disease. Berger said the target is validated by Entyvio, which he described as a backbone therapy in Crohn’s disease and ulcerative colitis because of its balance of efficacy and safety.

Berger said Gilead expects to present Phase 2 data for GS-1427 later this year at a medical conference. He said the company hopes to show differentiated efficacy and safety, with the added convenience of an oral therapy. He did not specify whether Gilead would prioritize monotherapy or combination approaches, saying the company would first present the data.

Long-Acting HIV Prevention and Treatment Remain Central

Berger also discussed YEZTUGO, Gilead’s twice-yearly injectable lenacapavir for HIV prevention, and a once-yearly intramuscular formulation being evaluated in the PURPOSE 365 Phase 3 study. He said that study has completed recruitment and is designed around pharmacokinetic and safety endpoints.

Berger said Gilead modeled the once-yearly dose to maintain protective lenacapavir levels for 52 weeks. He said the company believes end-of-period levels could remain higher than those seen with YEZTUGO’s twice-yearly subcutaneous dosing. Berger added that the FDA agreed to a pharmacokinetic-based study.

On market adoption, Berger said people in HIV prevention value optionality. He noted continued adoption of daily oral Descovy as well as YEZTUGO, and said Gilead has updated expectations for YEZTUGO to become a blockbuster by the end of the year.

In HIV treatment, Berger said Gilead expects data later this quarter from the ISLEND-1 and ISLEND-2 studies of once-weekly oral islatravir plus lenacapavir in virologically suppressed patients switching from regimens such as Biktarvy. He said Gilead wants to see the same level of viral suppression and good tolerability.

Berger also said Gilead is selecting components for a wholly owned weekly oral regimen combining an integrase inhibitor and a capsid inhibitor, and is evaluating longer-acting injectable treatment options. He said GS-3242 has shown pharmacokinetic data supporting at least dosing every four months, with higher-dose cohorts still ongoing as Gilead assesses whether it can reach a once-every-six-month schedule.

About Gilead Sciences NASDAQ: GILD

Gilead Sciences, Inc, founded in 1987 and headquartered in Foster City, California, is a biopharmaceutical company focused on the discovery, development and commercialization of medicines in areas of high unmet medical need. The company initially built its reputation in antiviral therapies and has since expanded into oncology, cell therapy and inflammatory diseases. Gilead operates a global research and commercial organization, conducting clinical development and selling medicines in markets around the world.

Gilead's product portfolio is anchored by antiviral therapies for HIV and viral hepatitis.

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