Fate Therapeutics Announces Presentations at 2026 ASCO and EULAR Annual Meetings Highlighting Off-the-Shelf CAR T-cell Therapy Pipeline for Cancer and Autoimmune Diseases

On May 21, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that data from its off-the-shelf CAR T-cell programs will be featured at the American Society of Cancer Oncology Annual Meeting to be held in Chicago, IL, May 29 – June 2, 2026 and at the European Congress of Rheumatology being held in London, UK, June 3-6, 2026.

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Presentation details are as follows:

ASCO – American Society of Cancer Oncology

Product Candidate: FT836

Title: Preliminary Phase 1 Results of a MICA/B-targeted CAR T-cell Designed to Overcome Solid Tumor Escape Mechanisms and Avoid the Requirement for Conditioning Chemotherapy

Session: Developmental Therapeutics—Immunotherapy

Poster Presentation Date / Time: Saturday, May 30th, 1:30-4:30 CT.

A link to the abstract can be found here: ASCO (Free ASCO Whitepaper) FATE

EULAR – European Congress of Rheumatology

Product Candidate: FT819

Title: Safety and Efficacy of an Off-the-Shelf Anti-CD19 CAR T-Cell Therapy With Reduced Conditioning in SLE: A Phase 1 Study Supporting Same-Day Discharge

Session: Clinical Poster Tours: From pathway to patient – therapeutic advances in Lupus (POS0079)

Poster Tour Date / Time: Thursday, June 4th, 9:30 a.m. BST

A link to the abstract can be found here: EULAR FATE

Product Candidate: FT839

Title: Off-the-Shelf Dual-CAR T-Cell Therapy: Targeting B and T Cells in Autoimmune Disease Without Preconditioning

Session: Basic Abstract Sessions: New therapeutic targets in Rheumatoid Arthritis and Sjogren’s (OPO156)

Oral Presentation Date / Time: Thursday, June 4th, 8:15 a.m. BST

A link to the abstract can be found here: EULAR FATE

About FT819

FT819 is an off-the-shelf CD19-targeting chimeric antigen receptor (CAR) T-cell product engineered to improve safety and efficacy. Analogous to master cell banks used to mass produce biopharmaceutical drug products such as monoclonal antibodies, a precisely engineered clonal master induced pluripotent stem cell (iPSC) bank serves as the starting cell source to manufacture FT819, overcoming numerous limitations associated with patient- and donor-sourced CAR T-cell therapies. FT819 is well-defined and uniform in composition, produced at a low cost of goods, and can be stored in inventory for off-the-shelf, on-demand availability to enable access for a broad patient population. This research was additionally made possible by funding from the California Institute for Regenerative Medicine (CIRM), a state agency in California that supports research in regenerative medicine, stem cell therapy, gene therapy, and clinical trials. (Grant number: CLIN2-16303)

(Press release, Fate Therapeutics, MAY 21, 2026, View Source [SID1234665925])

CytomX Therapeutics to Present at Upcoming June Investor Conferences

On May 21, 2026 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported that management will participate in the following investor conferences in June.

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Jefferies Global Healthcare Conference
Date: Thursday, June 4, 2026
Fireside Chat: 3:10 p.m. ET
Location: New York, NY

Goldman Sachs 47th Annual Global Healthcare Conference
Date: Wednesday, June 10, 2026
Fireside Chat: 9:20 a.m. ET
Location: Miami, FL

A live webcast of the presentation will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

(Press release, CytomX Therapeutics, MAY 21, 2026, View Source [SID1234665924])

Corbus Pharmaceuticals Announces the Appointment of Nishant Saxena as Chief Business Officer and Schedules a Pre-2026 ASCO CRB-701 Data Conference Call

On May 21, 2026 Corbus Pharmaceuticals Holdings, Inc. (Nasdaq: CRBP), a clinical-stage company focused on developing promising new therapies in oncology and obesity, reported that the Company’s management team will host a conference call and webcast on Tuesday, May 26 at 8:00 a.m. EDT to discuss updated data for its Phase 1/2 study of CRB-701, a next-generation Nectin-4 antibody drug candidate (ADC), in both head and neck squamous cell carcinoma (HNSCC) as well as cervical cancer. The data, which will be presented at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, represent an April 1, 2026 data cut, and will include clinical response durability data as well as HNSCC patient subgroup analysis.

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Corbus also announced today the appointment of former Evercore Managing Director Nishant Saxena as the Company’s first Chief Business Officer, as it advances toward two key anticipated pipeline milestones this summer: the initiation of a registrational study of CRB-701 in second-line HNSCC and the completion of the CANYON-1 Phase 1b dose-ranging, 16-week study (n=240) for CRB-913, a highly peripherally restricted oral CB1 inverse agonist.

"Nishant is an accomplished industry executive with deep expertise across mergers and acquisitions, licensing, partnerships, and capital markets," said Yuval Cohen, Ph.D., CEO of Corbus. "His proven track record of unlocking and delivering value coincides with our transition from an early clinical-stage company to one entering registrational-stage clinical development. We are excited and grateful that he has chosen to join the Corbus team."

Mr. Saxena commented, "The emerging clinical data for CRB-701 in oncology and CRB-913 in obesity are very encouraging, and the Corbus team has done an incredible job advancing these two assets toward important milestones this year," said Mr. Saxena. "I am excited by the clinical and commercial potential for both of these assets, and I look forward to working with Yuval and the rest of the leadership team to advance this portfolio toward its full value and impact."

Nishant Saxena Biographical Details

Mr. Saxena has over 20 years of experience in finance, strategy, capital markets, mergers and acquisitions, and corporate development. Most recently, he was Chief Financial Officer at Jeune Aesthetics, Inc., a wholly owned subsidiary of Krystal Biotech, Inc. (NASDAQ: KRYS). Previously, Mr. Saxena spent over 15 years at Evercore, most recently as a Managing Director in the healthcare group, where he advised on transactions totaling over $500 billion in aggregate value. Mr. Saxena led numerous client engagements and advised on mergers and acquisitions, private placements, initial public offerings, follow-on offerings, partnerships, and structured financing. Earlier in his career, Mr. Saxena held positions of increasing responsibility in private equity, venture capital, and investment advisory firms. Mr. Saxena received a B.S. in Economics and an MBA from the Wharton School at the University of Pennsylvania.

Pre-2026 ASCO (Free ASCO Whitepaper) Conference Call & Webcast Registration Details

Date: Tuesday, May 26, 2026
Time: 8:00 a.m. EDT
Investors Dial 1-877-704-4453
Int’l Investors Dial 1-201-389-0920
Conference ID 13760531
Webcast: Click here
CallMe: Click here

A replay will be available on the Corbus website.

CRB-701 2026 ASCO (Free ASCO Whitepaper) Data Presentation Details

The oral presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic cervical cancer," will be presented by Professor Yohann Loriot, Gustave Roussy (Paris) on Friday, May 29 at 4:57 p.m. CDT (Abstract #5508).

The poster presentation titled, "A phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with recurrent or metastatic head and neck squamous cell carcinoma," will be presented by Charlene Mantia, M.D., Dana-Farber Cancer Institute (Boston) on Saturday, May 30 at 4:30 p.m. CDT (Abstract #6062/Poster #519).

2026 ASCO (Free ASCO Whitepaper) HNSCC KOL Event Details

Corbus will host an in-person and virtual KOL event during the 2026 ASCO (Free ASCO Whitepaper) to discuss the updated data from the Phase 1/2 clinical study of CRB-701 in 75 participants with HNSCC.

Date: Monday, June 1, 2026
Time: 6:30 a.m. CDT
Location: Marriott Marquis Chicago
Participants: Corbus Management Team, joined by leading HNSCC Experts:
Ari Rosenberg, M.D., University of Chicago
Glenn Hanna, M.D., Dana-Farber Cancer Institute
Cesar Augusto Perez Batista, M.D., Sarah Cannon Research Institute

A live question-and-answer session will follow the formal presentation. To register for the KOL event, click here. A replay of the event will also be available on the Corbus website.

(Press release, Corbus Pharmaceuticals, MAY 21, 2026, View Source [SID1234665923])

Convergent Therapeutics to Present Largest Set of Prospective Phase 2 Data for an Alpha Radiopharmaceutical in Lu-PSMA-Exposed Metastatic Castration-Resistant Prostate Cancer at ASCO 2026

On May 21, 2026 Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation alpha radiopharmaceuticals for cancer, reported the abstract release for its oral presentation on June 1, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting. The abstract describes interim results from Part 3 of the CONVERGE-01 Phase 2 trial of Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received Lu-177-PSMA radioligand therapy (Lu-PSMA).

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The CONVERGE-01 Part 3 dataset represents the largest prospective Phase 2 evidence for an alpha-emitting radiopharmaceutical in Lu-PSMA exposed patients. This population has grown substantially with the establishment of Lu-PSMA therapy in mCRPC care, for which no subsequent standard of care exists.

The full data, including antitumor activity, emerging durability, and tolerability — notably clinically- manageable hematopoietic toxicity without renal toxicity or high-grade xerostomia — will be presented by Michael J. Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center.

"What will be presented at ASCO (Free ASCO Whitepaper) represents a meaningful step forward for patients navigating prostate cancer after Lu-PSMA therapy," said Phil Kantoff, MD, co-founder and CEO of Convergent Therapeutics. "CONVERGE-01 is a rigorous, prospective Phase 2 study evaluating CONV01-α in this growing Lu-PSMA-exposed population. We believe these data establish important benchmarks in this setting, and we look forward to its presentation at ASCO (Free ASCO Whitepaper)."

Based on the totality of the CONVERGE-01 data, Convergent is planning a pivotal Phase 3 study of CONV01-α in Lu-PSMA-exposed mCRPC patients beginning in mid 2027.

Demonstrated Tolerability Profile in a Heavily Pretreated Population

Patients enrolled in CONVERGE-01 Part 3 following extensive prior treatment exposure: all had received prior androgen deprivation therapy, androgen receptor pathway inhibitor therapy, and multiple cycles of Lu-PSMA therapy. Eighty percent of patients had also received prior taxane chemotherapy for mCRPC. Following treatment with CONV01-α, patients experienced a favorable safety and tolerability profile with clinically manageable hematopoietic toxicity, no renal toxicity, and no high-grade xerostomia.

Supply of Reliable, High-Quality Actinium-225

Actinium-225 supply has been a recognized constraint in the development of alpha radiopharmaceuticals, and reliable access to these radioisotopes is a prerequisite for late-stage development. Convergent has established a flexible, networked CMC process that allows for integration of multiple sources of Ac-225 from redundant suppliers and has secured Phase 3 supply via a recently expanded agreement with NorthStar Medical Radioisotopes for domestically supplied Ac-225 and co-located drug product manufacturing.

ASCO Presentation: Abstract Title: CONVERGE-01 Part 3: Ac-225 Rosopatamab Tetraxetan (CONV01-α) In Lu-PSMA Pretreated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Abstract Number: 5011
Format: Oral Presentation
Session Type/Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Date and Time: June 1, 3:00 PM-4:30 PM CDT
Presenter: Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center

About the CONVERGE-01 Trial
The CONVERGE-01 trial is a Phase 2, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received radiolabelled rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 enrolled participants naïve to Lu-PSMA and Part 3 enrolled participants who were previously exposed to Lu-PSMA-radioligand therapy. Participants received CONV01-α in a two-dose regimen administered on Days 1 and 15. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.

About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody directed against prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.

(Press release, Convergent Therapeutics, MAY 21, 2026, View Source [SID1234665922])

Bristol Myers Squibb to Unveil New Data at ASCO® 2026 Demonstrating Strength and Breadth of Scientific Innovation Across Oncology Portfolio and Next-Generation Pipeline

On May 21, 2026 Bristol Myers Squibb (NYSE: BMY) reported the presentation of data from its oncology portfolio and pipeline at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held May 29 – June 2 in Chicago, Illinois. Across more than 60 disclosures and 19 oral presentations, the Company will highlight progress from its differentiated oncology pipeline in solid tumors and hematologic malignancies.

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"This ASCO (Free ASCO Whitepaper) features the breadth of our oncology pipeline across multiple tumor types and different approaches such as bispecifics, ADCs and targeted therapies, and showcases the potential of our industry-leading CELMoD modality," said Cristian Massacesi, MD, executive vice president, chief medical officer and head of Development, Bristol Myers Squibb. "Throughout the meeting, we will also highlight novel combinations that we believe could offer innovative and meaningful options to people with cancer."

Key data to be presented by Bristol Myers Squibb and its collaborators include:

Delivering on the potential of targeted protein degradation with CELMoD (cereblon E3 ligase modulation) presentations in multiple myeloma and lymphoma

Late-breaking full results from the Phase 3 SUCCESSOR-2 trial of mezigdomide, an investigational, oral CELMoD, in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone in relapsed or refractory multiple myeloma will be shared in an oral presentation
Safety and 12-month efficacy results for golcadomide, a potential first-in-class investigational lymphoma CELMoD, in combination with pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma
Efficacy and safety of iberdomide, an investigational, oral CELMoD, in combination with daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma
Exploring novel approaches across breast, gastric and lung cancers

Two Phase 3 studies sponsored by SystImmune’s parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin) in Mainland China:
Late-breaking Phase 3 data for izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate (ADC), versus physician’s choice chemotherapy in patients with unresectable locally advanced, recurrent, or metastatic triple-negative breast cancer
Phase 3 results for iza-bren versus chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma
Outside of China, iza-bren is jointly developed by SystImmune and Bristol Myers Squibb
In partnership with BioNTech, the first global data for a PD-1 or PD-(L)1 x VEGF bispecific immunomodulator in previously untreated non-small cell lung cancer (NSCLC): Phase 2 data for pumitamig (PD-L1 x VEGF-A bispecific antibody) in combination with chemotherapy in first-line NSCLC
Expanding the evidence base for cell therapy and elevating real-world impact

Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma
First results from the Center for International Blood and Marrow Transplant Research (CIBMTR) showing real-world outcomes of Breyanzi(lisocabtagene maraleucel) in patients with relapsed or refractory chronic lymphocytic leukemia and relapsed or refractory mantle cell lymphoma
More details on these select studies to be presented at the 2026 Annual Meeting by the Company and its collaborators:

Abstract Title

Author

Presentation

Type /

Abstract #

Session Title

Session

Date/Time

(CDT)

Breast Cancer

PANKU-Breast02: izalontamab brengitecan vs physician’s choice chemotherapy in patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC): A randomized, Phase 3 study (BL-B01D1-307)(LBA)

Wu, J

Oral

#LBA1003

Breast Cancer – Metastatic

June 2,

2026

9:45 AM –

12:45 PM

Gastrointestinal Cancer

PANKU-Esophagus01: izalontamab brengitecan vs chemotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC), A multicenter, randomized, open-label, Phase 3 study (BL-B01D1-305)

Lu, Z

Oral

#4008

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

June 1,

2026

9:45 AM –

12:45 PM

Lymphoma

Golcadomide, a potential, first-in-class, oral CELMoD, + pola-RCHP in patients with newly diagnosed aggressive B-cell lymphoma: Safety and 12-month efficacy results

Hoffman, M

Oral

#7011

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

May 29,

2026

1:00 PM –

2:30 PM

Real-world patient characteristics, outcomes, and resource utilization of chimeric antigen receptor (CAR) T cell therapy across Foundation for the Accreditation of Cellular Therapy (FACT) and non-FACT treatment centers in large B-cell lymphoma

Raj, R

Poster

#7023

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Real-world outcomes of lisocabtagene maraleucel in patients with relapsed or refractory chronic lymphocytic leukemia: First results from CIBMTR

Tomasulo, E

Poster

#7024

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Outcomes of lisocabtagene maraleucel in patients with relapsed or refractory mantle cell lymphoma: First real-world data from the CIBMTR

Huang, J

Poster

#7026

Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

June 1,

2026

9:00 AM –

12:00 PM

Multiple Myeloma

Efficacy and safety of iberdomide, daratumumab, bortezomib and dexamethasone in patients with newly diagnosed multiple myeloma

Kapoor, P

Oral

#7514

Hematologic Malignancies – Plasma Cell Dyscrasia

May 31,

2026

9:45 AM –

11:15 AM

Mezigdomide, carfilzomib, and dexamethasone vs carfilzomib and dexamethasone in relapsed or refractory multiple myeloma: Result from the Phase 3 SUCCESSOR-2 trial (LBA)

Richardson, P

Oral

#LBA7506

Hematologic Malignancies – Plasma Cell Dyscrasia

May 29,

2026

2:45 PM –

5:45 PM

Thoracic Cancer

Phase 2 data from ROSETTA Lung-02, a global randomized Phase 2/3 trial of pumitamig (PD-L1 x VEGF-A bsAB) + chemotherapy in 1L NSCLC

Peters, S

Rapid Oral

#8513

Lung Cancer – Non-Small Cell Metastatic

May 30,

2026

1:15 PM –

2:45 PM

BREYANZI

INDICATIONS

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.
adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.
IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA-and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 769 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 56% of patients, including ≥ Grade 3 CRS in 3.4% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 99% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, chills, tachycardia, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 32% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7.5 days (range: 1 to 119 days). Of patients developing neurotoxicity, 83% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 33% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.5%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 9% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Seven out of 769 (0.9%) patients with R/R NHL exposed to BREYANZI developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 32 days. Of the 7 patients, 3 patients developed IEC-HS with overlapping occurrence of CRS and neurotoxicity, 2 patients developed IEC-HS with overlapping occurrence of neurotoxicity, and 1 patient developed IEC-HS with overlapping occurrence of CRS. IEC-HS was fatal in 2 of 7 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

LBCL are fever, CRS, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are CRS, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
MZL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

(Press release, Bristol-Myers Squibb, MAY 21, 2026, View Source [SID1234665921])