On May 15, 2025 I-Mab (NASDAQ: IMAB) (the "Company"), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported financial results for the three months ended March 31, 2025, and highlighted recent pipeline progress and business updates (Press release, I-Mab Biopharma, MAY 15, 2025, View Source [SID1234653169]).

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"2025 is off to a strong start for I-Mab. Designation of givastomig as our lead program has enabled us to unlock significant value for the Company by considerably accelerating our Phase 1b program, as we work to improve the care of patients with gastric cancers, which impact more than 250,000 people globally," said Sean Fu, PhD, Chief Executive Officer of I-Mab. "Driven by study momentum and investigator interest, we have completed patient enrollment in the first of two Phase 1b dose expansion cohorts ahead of schedule. We expect to share data on both cohorts in 1H 2026. We believe the combination of significant progress in our givastomig program, substantial cash balance, streamlined operations, and new U.S.-based business model positions I-Mab to deliver for both patients and our investors."

Pipeline Overview and Anticipated Upcoming Milestones

Upcoming anticipated milestones for givastomig (CLDN18.2 x 4-1BB bispecific), prioritized to be I-Mab’s lead program in January 2025:

•
July 2025: Presentation of new givastomig dose escalation combination data on U.S. patients at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ("ESMO") Gastrointestinal ("GI") Cancers Congress 2025, being held July 2-5 in Barcelona, Spain
Details of the ESMO (Free ESMO Whitepaper) GI Mini Oral Presentation:

Title: Preliminary Safety and Efficacy of Givastomig, a Novel Claudin 18.2/4-1BB Bispecific Antibody, in Combination with Nivolumab and mFOLFOX in Metastatic Gastroesophageal Carcinoma (mGEC)

Speaker: Samuel J. Klempner, MD, Associate Professor of Medicine, Massachusetts General Hospital

Presentation Number: 388MO

Date and Time: Wednesday, July 2nd at 16:50 CEST (10:50am EST)

•
1H 2026: Presentation of data from givastomig dose expansion cohorts (n=40)
Enrollment in the ongoing dose expansion study for givastomig is progressing ahead of schedule. In addition, the Company anticipates updates in 2026 for two programs being developed with its partners: uliledlimab (monoclonal antibody targeting CD73); and ragistomig (PD-L1 x 4-1BB bispecific).

First Quarter 2025 Financial Results – In connection with the divestiture of its Greater China assets and business operations, I-Mab’s first quarter 2024 amounts have been recast to conform to the discontinued operations presentation. Additionally, certain non-recurring costs occurred during the first quarter of 2024 that impact quarter-over-quarter comparisons.

Cash Position

As of March 31, 2025, the Company had cash and cash equivalents, and short-term investments of $168.6 million. The Company’s current cash position is expected to fund the givastomig Phase 1b study through anticipated dose expansion data readouts and further development initiatives into 2027.

Shares Outstanding

As of March 31, 2025, the Company had 187,818,796 ordinary shares issued and outstanding, representing the equivalent of 81,660,346 ADSs, assuming the conversion of all ordinary shares into ADSs.

Research and Development Expenses

Research and development expenses were $0.8 million for the three months ended March 31, 2025, compared to $6.1 million for the three months ended March 31, 2024. The decrease was primarily driven by reimbursements recognized under an existing collaboration agreement and lower contract research organization costs during the three months ended March 31, 2025.

Administrative Expenses

Administrative expenses were $4.5 million for the three months ended March 31, 2025, compared to $2.4 million for the three months ended March 31, 2024. Employee share-based compensation expenses during the three months ended March 31, 2024 were $4.8 million lower, primarily driven by forfeitures in connection with the divestiture of the Greater China assets and business operations. Additionally, legal expenses were $2.5 million lower during the three months ended March 31, 2025.

Interest Income

Interest income was $1.9 million for the three months ended March 31, 2025, compared to $0.7 million for the three months ended March 31, 2024. The increase was primarily attributable to higher interest rates earned on cash balances in 2025.

Other Income (Expenses), Net

Other income (expenses), net were $0.2 million for the three months ended March 31, 2025, compared to $(0.6) million for the three months ended March 31, 2024.

Equity in Loss of Affiliates

Equity in loss of affiliates was $1.0 million for the three months ended March 31, 2024 due to recognition of the employee stock ownership plan expenses from the Company’s unconsolidated investee as a result of the divestiture of the Greater China assets and business operations. There was no equity in loss of affiliates for the three months ended March 31, 2025.

Net Loss from Continuing Operations

Net loss from continuing operations was $(3.2) million for the three months ended March 31, 2025, compared to $(9.4) million for the three months ended March 31, 2024. Net loss from continuing operations per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.05) for the three months ended March 31, 2024.

Net Loss from Discontinued Operations

On April 2, 2024, the Company closed the China divestiture announced on February 7, 2024 (the "Transaction"). In accordance with ASC 205-20, the Company determined that the Transaction represented a strategic shift that had a major effect on the business and therefore, met the criteria for classification as discontinued operations. As a result, the Company recognized a loss from discontinued operations of $6.9 million for the three months ended March 31, 2024.

Net Loss

Net loss was $(3.2) million for the three months ended March 31, 2025, compared to $(16.3) million for the three months ended March 31, 2024. Net loss per share attributable to ordinary shareholders was $(0.02) for the three months ended March 31, 2025, compared to $(0.09) for the three months ended March 31, 2024.

About Givastomig

Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 ("CLDN18.2")-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for first line ("1L") metastatic gastric cancers, with further potential in other solid tumors. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.

The ongoing Phase 1b study is evaluating givastomig for the treatment of gastric cancer in the 1L setting in combination with standard of care, nivolumab (an anti-PD-1 checkpoint inhibitor) plus chemotherapy, in dose escalation and dose expansion cohorts. Dose escalation is complete, and enrollment in the first dose expansion cohort (n=20) finished ahead of schedule. Enrollment continues to progress ahead of schedule in the second dose expansion cohort (n=20). The study builds on positive Phase 1 monotherapy data.

Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

On May 15, 2025 Agenus Inc. ("Agenus" or the Company") (NASDAQ: AGEN), a leader in immuno-oncology, reported new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Gastrointestinal Cancers Congress in Barcelona, Spain (Press release, Agenus, MAY 15, 2025, View Source [SID1234653187]). A poster presentation will feature updated findings from an expanded cohort of 123 patients, incorporating additional participants and extended follow-up to further assess clinical activity of the combination, including durability of response and overall survival (NCT03860272).

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Presentation Details:

Presentation: Botensilimab plus balstilimab in an expanded cohort of 123 patients with metastatic microsatellite stable colorectal cancer and no active liver metastases

Presenting Author: Dr. Benjamin Schlechter, Dana Farber Cancer Institute

Poster Number: 8P

Session Date and Time: 7/4/2025, 3:30 PM – 4:30 PM CEST (9:30 AM – 10:30 AM EDT)

About Botensilimab (BOT)

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov.

About Balstilimab (BAL)

Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in >900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types.

On May 15, 2025 BrainChild Bio, Inc., a clinical-stage biotechnology company developing CAR T-cell therapies to treat tumors in the central nervous system (CNS), reported that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor (Press release, BrainChild Bio, MAY 15, 2025, View Source [SID1234653203]).

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The use of a regenerative medicine, specifically a CAR T-cell therapy, offers the potential to overcome barriers for other drug modalities to be effective in addressing DIPG, including the precarious location of the DIPG tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains intact during tumor progression. BrainChild Bio has designed BCB-276 to be administered by locoregional delivery of targeted CAR T-cells directly into the cerebrospinal fluid, permitting infused CAR T-cells to directly access the tumor bed, using an indwelling reservoir-catheter device.

This approach to administering an autologous B7-H3 CAR T-cell therapy has been successfully implemented and resulted in the promising overall survival benefit in patients with brain tumors observed in the BrainChild-03 Phase 1 trial (NCT04185038), conducted by BrainChild Bio’s academic partner, Seattle Children’s Research Institute, and recently published in Nature Medicine.

"We are very pleased to now also receive RMAT designation, less than one month after being granted Breakthrough Therapy designation from FDA for our lead CAR T therapy, BCB-276, for the treatment of DIPG. Receiving designations from two independent reviews within FDA further validates the positive CAR-T clinical results achieved by our team to date and the urgent need for a treatment for DIPG," stated Michael Jensen, MD, Founder and Chief Scientific Officer of BrainChild Bio. "Our team is keenly focused on initiating the pivotal Phase 2 trial by the end of this year and look forward to continuing to work with the FDA on an accelerated path forward to bring potential new CAR-T treatments for CNS brain tumors in children and adults."

FDA grants RMAT designation to investigational regenerative medicine therapies, including cell therapies, that are aimed at treating serious or life-threatening diseases have shown preliminary clinical evidence that the drug has the potential to address unmet medical needs for the disease. Investigational medicines with RMAT are provided intensive interactions with the FDA during the product candidate’s development process in addition to being eligible for rolling submission and priority review of the marketing application.

"It’s gratifying to see another important benchmark reached in our work to combat pediatric brain cancer," said Dr. Jeff Sperring, Chief Executive Officer at Seattle Children’s. "Our research is the foundation of progress to bring potential therapies to kids as fast as we can – and we’re excited about the possibilities afforded by this designation."

BrainChild Bio is preparing to advance BCB-276 in a Phase 2 multi-center, pivotal registration trial to support a potential Biologics License Application (BLA) to the FDA for the treatment of children and young adults with DIPG. This clinical plan is based on alignment between BrainChild Bio and FDA at a Type B meeting in late 2024.

About Diffuse Intrinsic Pontine Glioma (DIPG) and Application of CAR T-cell Therapies

Diffuse intrinsic pontine glioma (DIPG) is a primary high-grade brain tumor that arises in the pons and is uniformly fatal. DIPG affects approximately 300 children per year in the U.S. with the majority of diagnoses made in children between 5 and 10 years of age. Current standard-of-care treatment remains limited to palliative focal radiation therapy which results in a median overall survival of only about 11 months from diagnosis.1 Barriers to effective therapies for DIPG include the precarious location of the tumor in the brainstem, the infiltrative growth of the tumor throughout normal brainstem functional anatomy, and the blood brain barrier that remains relatively intact during tumor progression preventing therapies from gaining access to the cancer.

The barriers to effective therapies for DIPG can be effectively overcome by the locoregional delivery of appropriately targeted CAR T-cells directly into the cerebrospinal fluid via intracerebroventricular (ICV) dosing with an indwelling reservoir-catheter device. This enables the potential for extensive exposure of the pons to cerebrospinal fluid flow from the ventricular system, thus permitting infused CAR T-cells to directly access the tumor bed. This also allows for repetitive infusions of CAR T-cells to replenish the tumor bed, offering the potential for more durable and sustained efficacy. Additionally, with the blood brain barrier intact, this therapeutic approach can also minimize any on-target, off-tumor toxicities resulting from systemic exposure of CAR T-cells.

On May 15, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that an abstract regarding IPH6501, its ANKET targeting CD20 B cells currently developed in relapsed and/or refractory Non-Hodgkin Lymphoma, has been selected for the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2025, taking place June 12-15 in Milan, Italy (Press release, Innate Pharma, MAY 15, 2025, View Source [SID1234653170]).

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Abstract details
Antitumor characterization of IPH6501, a novel il2v-armed tetraspecific NK cell engager targeting CD20 B cells, in DLBCL and FL patient samples, and in preclinical combination with R-CHOP
•Abstract Code: PS2004
•Session: Poster session 2
•Session Date/Time: Saturday, June 14, 2025, 18:30 – 19:30 CEST
•More information can be found on the EHA (Free EHA Whitepaper) website.

In addition, an abstract related to SAR’514/IPH6401 (developed by Sanofi) was accepted for online publication.

The BCMA NK Cell Engager SAR’514 Induces Macrophage-Mediated Phagocytosis which is improved by combination with Evorpacept, a CD47 Blocker, in Multiple Myeloma
•Abstract Code: PB2850

About ANKET
ANKET (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. This versatile, fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6501
IPH6501 is the first Antibody-based NK cell Engager Therapeutic to co-engage activating receptors on NK cells (NKp46 and CD16), IL-2R (but not the alpha subunit) through a variant of human IL-2, and a tumor antigen (CD20) via a single molecule, hence providing proliferation and activation signals targeted to NK cells and promoting their cytotoxic activity against CD20 expressing malignant cells.

IPH6501 has shown better anti-tumor efficacy than approved benchmark antibodies in preclinical tumor models (Demaria, EHA (Free EHA Whitepaper) 2023, Carrette, SITC (Free SITC Whitepaper) 2024, Demaria et al, Science Immunology 2024).

IPH6501 is currently being evaluated in a Phase 1/2 multicenter trial (NCT06088654), investigating the safety and tolerability of IPH6501 in patients with relapsed and/or refractory CD20-expressing B-cell Non-Hodgkin’s Lymphoma.

On May 15, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported that it will present more than 20 abstracts across both Gilead and Kite at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting May 30 – June 3 and the 2025 European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress June 12 – 15 (Press release, Gilead Sciences, MAY 15, 2025, View Source [SID1234653188]). 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).

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At ASCO (Free ASCO Whitepaper), Gilead will present detailed late-breaking results from the Phase 3 ASCENT-04 study showing a statistically significant and clinically meaningful benefit in progression-free survival for Trodelvy plus Keytruda versus Keytruda and standard of care chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (Abstract #LBA109). Additionally, Kite research collaborators at the University of Pennsylvania Perelman School of Medicine will present Phase 1 results evaluating a novel investigational CAR T-cell therapy using a dual-target approach in patients with recurrent glioblastoma during an oral session at ASCO (Free ASCO Whitepaper) (Abstract #102).

At EHA (Free EHA Whitepaper), Kite and its partner Arcellx will present updated findings from the Phase 2 registrational iMMagine-1 study of anitocabtagene-autoleucel (anito-cel) 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 orals across ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper).

"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," said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. "Data at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) will feature novel pipeline approaches with antibody-drug conjugate therapy and cell therapy, helping to drive oncology innovation and change medical practice."

Summary of Presentations

Accepted abstracts at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting include:

Tumor Types

Abstract Title

Metastatic Triple-Negative Breast Cancer

Abstract #LBA109

May 31, 2025

3:35 – 3:47 PM CDT

(Oral Presentation)

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

Abstract #511

June 1, 2025

8:12 – 8:18 AM CDT

(Oral Presentation)

A Phase 2 Study of Response-Guided Neoadjuvant Sacituzumab Govitecan and Pembrolizumab (SG/P) in Patients with Early-Stage Triple-Negative Breast Cancer: Results from the NeoSTAR Trial*

Lung Cancer

Abstract #8599

May 31, 2025

1:30 – 4:30 PM CDT

(Poster)

Longer Follow-up for Survival and Safety from the EVOKE-01 Trial of Sacituzumab Govitecan (SG) vs Docetaxel in Patients (pts) with Metastatic Non-small Cell Lung Cancer

Abstract #8522

May 31, 2025

1:30 – 4:30 PM CDT

(Poster)

Exploratory ctDNA Analyses for the EVOKE-1 Study in Metastatic Non-small Cell Lung Cancer

Abstract #11154

May 31, 2025

1:30 – 4:30 PM CDT

(Poster)

Characterizing Health Related Quality of Life Among Individuals Living with Non-Small Cell Lung Cancer in the United States: Findings from the Cancer Experience Registry

Endometrial Cancer

Abstract # e17624

May 22, 2025

4:00 PM CDT

(Online Publication Only)

Trop-2 Expression and its Prognostic Impact on Endometrial Cancer: A Real-world Data Analysis

Glioblastoma

Abstract #102

June 1, 2025

10:09 – 10:21 AM CDT

(Oral Presentation)

A Phase 1 Study of Intracerebroventricular Delivery of Bivalent CAR T-Cells Targeting EGFR and IL13Rα2 in Patients with Recurrent Glioblastoma**

Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas

Abstract #4033

May 31, 2025

9:00 AM – 12:00 PM CDT

(Poster)

Real-world Analyses to Evaluate the Role of TIGIT as a Target in First-line (1L) Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas

Head and Neck Squamous Cell Carcinoma (HNSCC)

Abstract # e18011

May 22, 2025

4:00 PM CDT

(Trial in Progress [TiP], Online Publication Only)

A Phase 2 Study of First-line Domvanalimab, Zimberelimab, and Chemotherapy in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Substudy-01 of the VELOCITY-HNSCC Platform Trial

B-cell Lymphoma

Abstract #7003

May 30, 2025

3:45 – 3:57 PM CDT

(Oral Presentation)

A Phase 1 Study of KITE-363 Anti-CD19/CD20 Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients (pts) with Relapsed/Refractory (R/R) B-cell Lymphoma

Large B-cell Lymphoma

Abstract #7023

June 1, 2025

9:00 AM – 12:00 PM CDT

(Poster)

Trends and Outcomes by Inpatient and Outpatient Infusion of Axicabtagene Ciloleucel (Axi-cel) in the US for Patients (Pts) with Relapsed / Refractory Large B-Cell Lymphoma

Secondary Central Nervous System Lymphoma

Abstract #2020

May 31, 2025

4:12 – 4:18 PM CDT

(Oral Presentation)

Using Single-Cell Transcriptomics to Reveal CD226 Upregulation and Enhancement of CD19-CAR-T Function in the Inhibitory CNS Microenvironment of Refractory CNS Lymphoma***

Abstract #7024

June 1, 2025

9:00 AM – 12:00 PM CDT

(Poster)

Real-world Outcomes of Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapsed/Refractory (R/R) Secondary Central Nervous System Lymphoma

*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 (Free EHA Whitepaper) 2025 Annual Congress include:

Tumor Types

Abstract Title

Acute Lymphoblastic Leukemia

Abstract #PF374

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Five-year Survival Outcomes of Patients (Pts) With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (R/R B-ALL) Treated with Brexucabtagene Autoleucel (Brexu-cel) In ZUMA-3

Large B-cell Lymphoma

Abstract #PF1168

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Cost-effectiveness of Real-world Axicabtagene Ciloleucel Use in Relapsed/Refractory 2L LBCL Based on a Multi-center US Registry

Abstract #PF1002

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Prognostic Value of Circulating Tumor DNA (ctDNA) Detection by PhasED-Seq after Axicabtagene Ciloleucel (Axi-cel) Therapy in Relapsed/Refractory Large B-cell Lymphoma

Abstract #PF1304

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Health Impact of Chimeric Antigen Receptor T-Cell Vein-to-Vein Time in Second-Line Large B-Cell Lymphoma Patients: An Exploratory Modelling Analysis for Italy

Abstract #S237

June 13, 2025

5:00 – 6:15 PM CEST

(Oral Presentation)

Real-world Effectiveness and Safety Outcomes Among Key Subgroups of Second-line (2L) Axicabtagene Ciloleucel (Axi-cel) for Patients with Relapsed/Refractory (R/R) Large B-cell Lymphoma (LBCL)

Abstract # PB3232

May 14, 2025

(Publication Only)

The Italian Commercial Axi-cel Manufacturing Performance: A Retrospective Analysis of an Efficient and Reliable Process Over Time

Abstract # PB3238

May 14, 2025

(Publication Only)

Clinical, Economic, and Humanistic Outcomes of First-line High-Risk Large B-Cell Lymphoma: A Series of Systematic Literature Reviews

Mantle Cell Lymphoma

Abstract #PF954

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) in Patients (Pts) with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): A Systematic Literature Review (SLR) And Meta-analysis

Multiple Myeloma

Abstract #S201

June 14, 2025

5:00 – 6:15 PM CEST

(Oral Presentation)

Phase 2 Registrational Study of Anitocabtagene-Autoleucel for Relapsed and/or Refractory Multiple Myeloma (RRMM): Updated Results from iMMagine-1

Abstract #PF1294

June 13, 2025

6:30 – 7:30 PM CEST

(Poster)

Understanding Caregiver Challenges in Multiple Myeloma (MM): A Systematic Literature Review (SLR) of the Qualitative and Quantitative Literature

Anitocabtagene autoleucel is an investigational therapy. Neither Kite or Arcellx has received approval from any regulatory authority for any use of this therapy, and its safety and efficacy has not been established.

The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic TNBC is investigational, and the safety and efficacy of this use have not been established. Trodelvy has a Boxed Warning for severe or life-threatening neutropenia and severe diarrhea; please see below for the approved U.S. Indications and additional Important Safety Information.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Trodelvy

Trodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect.

Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer.

Trodelvy is currently being evaluated in multiple ongoing Phase 3 trials across a range of tumor types with high Trop-2 expression. These studies with Trodelvy, both in monotherapy and in combination with pembrolizumab, involve earlier lines of treatment for TNBC and HR+/HER2- breast cancer—including in curative settings—as well as in lung and gynecologic cancers, where previous proof-of-concept studies have demonstrated clinical activity.

Indications for Trodelvy

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Important Safety Information for Trodelvy

BOXED WARNING: NEUTROPENIA AND DIARRHEA

TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay.
TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.
CONTRAINDICATIONS

Severe hypersensitivity reaction to TRODELVY.
WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI.

Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions.

Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting. Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%).

In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes.

In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY.

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