Gilead and Kite to Present Key CAR T and Cancer Data at 2025 ASCO and EHA

Gilead and Kite Set to Showcase Transformative Oncology Data at 2025 ASCO and EHA Conferences, Highlighting Advances in Breast Cancer, Multiple Myeloma, and Glioblastoma

Gilead Sciences,and its Kite subsidiary are poised to deliver a powerful presence at two of the most influential oncology meetings of the year—the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 to June 3 in Chicago, and the 2025 European Hematology Association (EHA) Annual Congress, scheduled for June 12 to 15 in Madrid. Across these two marquee events, the company will present more than 20 scientific abstracts, underscoring the depth and breadth of its oncology pipeline in both solid tumors and hematologic malignancies.

The presentations will highlight significant strides in difficult-to-treat cancers, including triple-negative breast cancer (TNBC), glioblastoma, and relapsed or refractory multiple myeloma. Gilead’s expanding research portfolio reflects a multi-modal strategy encompassing antibody-drug conjugates (ADCs), checkpoint inhibitors, and next-generation cell therapies, particularly chimeric antigen receptor (CAR) T-cell therapies developed through Kite and in collaboration with partners like Arcellx and the University of Pennsylvania.

Major ASCO 2025 Presentation: Trodelvy Plus Keytruda in 1L PD-L1+ Metastatic TNBC

At the heart of Gilead’s ASCO presentations will be a highly anticipated late-breaking abstract featuring pivotal results from the Phase 3 ASCENT-04 clinical trial. This randomized study evaluated the combination of Trodelvy® (sacituzumab govitecan-hziy), an antibody-drug conjugate developed by Gilead, with Keytruda® (pembrolizumab), Merck’s anti-PD-1 therapy, versus the current standard of care (Keytruda plus chemotherapy) in patients with inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1.

According to the abstract (LBA109), the trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in favor of the Trodelvy plus Keytruda combination. These data represent a potential paradigm shift in first-line treatment for PD-L1-positive metastatic TNBC—a notoriously aggressive and challenging subtype of breast cancer that disproportionately affects younger women and those with limited therapeutic options.

The ASCENT-04 trial findings could significantly elevate Trodelvy’s standing in the TNBC landscape. Already approved in later lines of therapy for metastatic TNBC and other indications, Trodelvy’s activity in earlier treatment settings—and particularly in synergy with immunotherapy—may offer patients a more effective, less toxic alternative to traditional chemotherapy.

“This marks a milestone in our ongoing commitment to improving outcomes for patients with difficult-to-treat cancers like triple-negative breast cancer,” said Dr. Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “These late-breaking data demonstrate how innovative combinations of antibody-drug conjugates with immunotherapy can deliver real progress for patients who currently face very limited options.”

Breakthrough CAR T Data in Glioblastoma From University of Pennsylvania and Kite

Another highlight at ASCO 2025 will be a presentation by researchers at the University of Pennsylvania Perelman School of Medicine, working in collaboration with Kite, focusing on an investigational dual-target CAR T-cell therapy for recurrent glioblastoma. The Phase 1 clinical trial results (Abstract #102) will be presented in an oral session, offering early insights into a novel approach for one of the most lethal and treatment-resistant brain tumors.

The CAR T candidate under investigation uses a dual-targeting strategy to overcome glioblastoma’s notorious heterogeneity and immune evasion. While CAR T-cell therapies have demonstrated tremendous success in hematologic cancers, their application in solid tumors—particularly in the central nervous system—has been limited due to challenges in tumor penetration, antigen escape, and immunosuppressive microenvironments.

This first-in-human trial evaluates both safety and preliminary signs of efficacy, as well as biological activity such as persistence and trafficking of the engineered T cells to the tumor site. If the therapy continues to show promise in future stages of development, it could open a new chapter in the treatment of primary brain tumors.

“Glioblastoma remains a devastating diagnosis, and innovation in this space is urgently needed,” said Dr. Berger. “Through partnerships with leading academic institutions, we are working to harness the full potential of cell therapy even in cancers that have previously been unresponsive to immunologic interventions.”

EHA 2025: Promising Results From the iMMagine-1 Study in Multiple Myeloma

At the EHA 2025 Congress, Kite and its strategic partner Arcellx will deliver an oral presentation of updated results from the Phase 2 iMMagine-1 study, a registrational trial investigating anitocabtagene-autoleucel (anito-cel) in patients with relapsed or refractory multiple myeloma (RRMM). The abstract (#S201) will provide new data on response rates, durability, and safety.

Anito-cel is a novel CAR T-cell therapy that targets BCMA (B-cell maturation antigen), a protein widely expressed on myeloma cells. Arcellx’s technology utilizes its proprietary D-Domain platform to potentially offer advantages over existing BCMA-directed cell therapies in terms of manufacturing consistency, antigen binding, and immune synapse formation.

The iMMagine-1 trial is expected to support regulatory filings for anito-cel in heavily pretreated RRMM patients who have exhausted other therapeutic classes such as immunomodulators, proteasome inhibitors, and anti-CD38 monoclonal antibodies.

If approved, anito-cel could join a rapidly growing class of BCMA-directed cell therapies, potentially differentiating itself through durability of response and logistical advantages in manufacturing and delivery. Gilead and Kite’s increasing footprint in myeloma reflects a strategic effort to diversify their cell therapy franchise beyond lymphoma.

Broader Oncology Footprint: Expanding Modalities and Indications

Beyond the marquee presentations in breast cancer, glioblastoma, and myeloma, Gilead and Kite will also unveil data from ongoing studies across a wide array of malignancies, both solid and hematologic. These include:

  • Lung cancer
  • Endometrial cancer
  • Gastric cancer
  • Large B-cell lymphoma
  • Indolent non-Hodgkin lymphoma
  • Acute lymphoblastic leukemia

Among the pipeline therapies being showcased is KITE-363, a dual-targeting CAR T candidate designed to address antigen escape and improve efficacy in B-cell malignancies by targeting both CD19 and CD20.

The data from ASCO and EHA will not only reinforce Gilead and Kite’s clinical momentum but also illuminate the company’s broader research strategy focused on next-generation ADCs, checkpoint inhibitor combinations, and novel CAR T platforms. By advancing assets across both solid and liquid tumors, Gilead is leveraging synergies between antibody and cell-based therapies, while expanding its footprint into earlier lines of therapy and more diverse cancer types.

A Bold Vision for Oncology Innovation

Gilead’s strategy in oncology, bolstered by its 2020 acquisition of Immunomedics and continued investment in Kite, has positioned the company as a rising force in cancer treatment. With a focus on high-unmet-need indications, differentiated mechanisms of action, and potentially transformative outcomes, the company is executing a bold vision to challenge existing standards and bring better therapies to patients faster.

“Our oncology portfolio is broad and diverse by design, as we continue to innovate with next-generation therapies and combinations to deliver improved outcomes,” Dr. Berger emphasized. “The data we’re presenting at ASCO and EHA reflect the growing strength of our pipeline and our mission to transform how cancer is treated.”

As Gilead and Kite head into these major conferences, all eyes will be on the new data to gauge how their assets are performing relative to competitors in crowded but rapidly evolving markets. If the presentations deliver on their promise, 2025 could mark a turning point for Gilead’s standing in oncology—not just as a participant, but as a leader redefining the future of cancer care.

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