ASCO 2025: Transformative Data in 1L Metastatic Triple-Negative Breast Cancer, Updated Results in Multiple Myeloma and Early Data From Novel Investigational CAR T-Cell Therapy Targeting Brain Cancer

During the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 – June 3, and the 2025 European Hematology Association (EHA) Annual Congress, held June 12 – 15 Gilead Sciences, will present more than 20 abstracts.

The studies span breast cancer and other solid tumors (glioblastoma, endometrial cancer, lung cancer, gastric cancer), as well as multiple blood cancers (multiple myeloma, large B-cell lymphoma, indolent non-Hodgkin lymphoma, acute lymphoblastic leukemia).

Late-Breaking Data from the Phase 3 ASCENT-04/KEYNOTE-D19 Study Evaluating sacituzumab govitecan plus pembrolizumab in First-Line PD-L1+ Metastatic Triple-Negative Breast Cancer

 

At ASCO, Gilead presents detailed late-breaking results from the Phase 3 ASCENT-04 study (NCT02574455) showing a statistically significant and clinically meaningful benefit in progression-free survival for sacituzumab govitecan (Trodelvy^®; Gilead), an antibody-drug conjugate (ADC; see ADC Drugmap) that targets the human trophoblast cell-surface antigen 2 to deliver SN-38 to cancer cells, plus pembrolizumab (Keytruda^®; Merck & Co/MSD outside Canada and the United States) versus pembrolizumab and standard of care chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (Abstract #LBA109).[1][2]

Triple-negative breast cancer
TNBC is the most aggressive type of breast cancer and has historically been difficult to treat. The disease accounts for approximately 15% of all breast cancers and is diagnosed more frequently in younger and premenopausal women. The disease is also more prevalent in Black and Hispanic women.[3][4][5]

Because TNBC cells do not have estrogen and progesterone receptors and have limited HER2, treatment options are minimal compared with other breast cancer types. Furthermore, TNBC has a higher chance of recurrence and metastases than other breast cancer types.[3][4][5]

The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with mTNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC.[3][4][5]

Despite treatment progress, first-line mTNBC has seen limited new approvals in recent years for tumors that express PD-L1+, and additional options are urgently needed. Despite recent advances, over 50% of patients do not receive treatment beyond first-line, reinforcing the urgent need for new options to help improve patient outcomes. Breast cancers expressing PD-L1 are overall more aggressive and associated with reduced survival time.[5]

Dual-target CAR T-cell therapy
Additionally, Kite research collaborators at the University of Pennsylvania’s Abramson Cancer Center (ACC) and Perelman School of Medicine present Phase 1 results evaluating a novel investigational dual-target CAR T-cell therapy in patients with recurrent glioblastoma during an oral session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 102) and simultaneously published in Nature Medicine. [6]

Despite decades of focused research, glioblastoma (GBM) remains the most common and malignant primary brain tumor in adults. Radiotherapy has long been an important treatment for GBM. Despite recent advances in tumor radiotherapy, the prognosis of GBM  is poor, with average life expectancies of 12-18 months after diagnosis. The median survival data for recurrent glioblastoma.[7]

Researchers at the University of Pennsylvania Perelman School of Medicine found that a dual-target CAR T-cell therapy approach showed promise for slowing tumor growth in a notoriously aggressive, fast-growing brain cancer. Tumors shrank after experimental CAR T-cell therapy in nearly two-thirds of patients. Although survival data are still accumulating, several patients lived 12 months or longer after receiving the investigational treatment, which is notable given that the typical survival for this patient population is less than a year.

The results build on the hopeful momentum of an early report from the same phase I clinical trial published last in 2024 in Nature Medicine, alongside similar findings from other researchers across the United States.[8]

Multiple Myeloma
At EHA, Kite and its partner Arcellx will present updated findings from the Phase 2 registrational iMMagine-1 study of anitocabtagene autoleucel (anitocel; NCT05396885) in relapsed/refractory multiple myeloma during an oral presentation (Abstract #S201).

Additional abstracts supporting pipeline therapies (e.g., KITE-363, a C19/20 dual-target CAR T) and results from collaborative studies will also be presented as oral presentations at ASCO and EHA.

“Our oncology portfolio is broad and diverse by design, as we continue to innovate with next-generation therapies and combinations to deliver improved outcomes and ultimately seek to transform how cancer is treated,” noted Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences.

“Data at ASCO and EHA will feature novel pipeline approaches with antibody-drug conjugate therapy and cell therapy, helping to drive oncology innovation and change medical practice,” Berger explained.

Summary of Presentations
Accepted abstracts at the 2025 ASCO Annual Meeting include:

*Collaborative study with Massachusetts General Hospital and Dana-Farber Cancer Institute

**Collaborative study with the University of Pennsylvania Perelman School of Medicine

***Collaborative study with Dana-Farber Cancer Institute

Summary of Presentations

Accepted abstracts at the EHA 2025 Annual Congress include:

Note: * Anitocabtagene autoleucel is an investigational therapy. Neither Kite nor Arcellx has received regulatory approval for any use of this therapy, and its safety and efficacy have not been established.

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Clinical trials
Trial of Sacituzumab Govitecan in Participants With Refractory/​Relapsed Metastatic Triple-Negative Breast Cancer (TNBC) (ASCENT) – ClinicalTrials.gov ID NCT02574455
Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1) (iMMagine-1) – ClinicalTrials.gov ID NCT05396885

Highlights of prescribing information
Sacituzumab govitecan (Trodelvy^®; Gilead)[Prescribing Information]
Pembrolizumab (Keytruda^®; Merck & Co)[Prescribing Information]

Reference
[1] Cheng SX, Chen QC, Lin GH, Han YH, Wang BC, Dai Y, Zhao YX. An integrated analysis of Sacituzumab govitecan in relapsed or refractory metastatic triple-negative breast cancer. Medicine (Baltimore). 2023 Jul 28;102(30):e34486. doi: 10.1097/MD.0000000000034486. PMID: 37505137; PMCID: PMC10378904.
[2] Tolaney S, De Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, Rapoport B, Im SA, Pistilli B, McHayleh W, Cescon D, Watanabe J, Lara A, Freitas-Junior R, Bofill J, Afshari M, Gary D, Wang L, Lai C, Schmid P. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. J Clin Oncol 43, 2025 (suppl 17; abstr LBA109) [Article]
[3] Derakhshan F, Reis-Filho JS. Pathogenesis of Triple-Negative Breast Cancer. Annu Rev Pathol. 2022 Jan 24;17:181-204. doi: 10.1146/annurev-pathol-042420-093238. PMID: 35073169; PMCID: PMC9231507.
[4] Howard FM, Olopade OI. Epidemiology of Triple-Negative Breast Cancer: A Review. Cancer J. 2021 Jan-Feb 01;27(1):8-16. doi: 10.1097/PPO.0000000000000500. PMID: 33475288; PMCID: PMC12050094.
[5] Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, Sardesai SD, Kalinsky K, Zelnak AB, Weaver R, Traina T, Dalenc F, Aftimos P, Lynce F, Diab S, Cortés J, O’Shaughnessy J, Diéras V, Ferrario C, Schmid P, Carey LA, Gianni L, Piccart MJ, Loibl S, Goldenberg DM, Hong Q, Olivo MS, Itri LM, Rugo HS; ASCENT Clinical Trial Investigators. Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2021 Apr 22;384(16):1529-1541. doi: 10.1056/NEJMoa2028485. PMID: 33882206.
[6]Bagley SJ, Desai AS, Fraietta JA, Silverbush D, Chafamo D, Freeburg NF, Gopikrishna GK, Rech AJ, Nabavizadeh A, Bagley LJ, Park J, Jarocha D, Martins R, Sarmiento N, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz RM, Jadlowsky JK, Mackey S, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Barrett D, Colbourn R, Nasrallah MP, Mourelatos Z, Hwang WT, Alanio C, Siegel DL, June CH, Hexner EO, Binder ZA, O’Rourke DM. Intracerebroventricular bivalent CAR T cells targeting EGFR and IL-13Rα2 in recurrent glioblastoma: a phase 1 trial. Nat Med. 2025 Aug;31(8):2778-2787. doi: 10.1038/s41591-025-03745-0. Epub 2025 Jun 1. Erratum in: Nat Med. 2025 Sep;31(9):3205. doi: 10.1038/s41591-025-03824-2. PMID: 40451950.
[7] Ma R, Taphoorn MJB, Plaha P. Advances in the management of glioblastoma. J Neurol Neurosurg Psychiatry. 2021 Oct;92(10):1103-1111. doi: 10.1136/jnnp-2020-325334. Epub 2021 Jun 23. PMID: 34162730.
[8] Bagley SJ, Logun M, Fraietta JA, Wang X, Desai AS, Bagley LJ, Nabavizadeh A, Jarocha D, Martins R, Maloney E, Lledo L, Stein C, Marshall A, Leskowitz R, Jadlowsky JK, Christensen S, Oner BS, Plesa G, Brennan A, Gonzalez V, Chen F, Sun Y, Gladney W, Barrett D, Nasrallah MP, Hwang WT, Ming GL, Song H, Siegel DL, June CH, Hexner EO, Binder ZA, O’Rourke DM. Intrathecal bivalent CAR T cells targeting EGFR and IL13Rα2 in recurrent glioblastoma: phase 1 trial interim results. Nat Med. 2024 May;30(5):1320-1329. doi: 10.1038/s41591-024-02893-z. Epub 2024 Mar 13. PMID: 38480922.

Featured image: Chicago, IL – 2016 ASCO Annual Meeting. Photo courtesy © 2016 – 2025 Max Gersh/ASCO/ used with permission.

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