RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Conditional marketing approval (China), Conditional marketing approval (European Union), Fast Track (European Union), Priority Review (United States), PRIME (European Union), Breakthrough Therapy (United States)

Structure/Sequence

Sequence Code 10256963L

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Sequence Code 315617079L

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Sequence Code 432311657H

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Sequence Code 432311660H

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Clinical Trials associated with Elranatamab

NCT06832865

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Elranatamab in Combination With Isatuximab (ELISA) in Relapsed and Refractory Multiple Myeloma

This is an open-label phase 2 study of elranatamab in combination with isatuximab administered subcutaneously in patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy and who have had previous treatment with both immunomodulatory drugs (IMiDs) and a proteasome inhibitor (PI). The subcutaneous injection method of isatuximab administration, including the device used to administer isatuximab, is investigational.

Start Date01 Aug 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+2]

NCT06421675

/ Not yet recruitingPhase 2IIT

A Study of Elranatamab Management with Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma

A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.

Start Date01 May 2025

Sponsor / Collaborator

Ontario Clinical Oncology Group

[+1]

NCT06799026

/ Not yet recruitingPhase 1IIT

A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fusions in Combination With Elranatamab in Relapsed or Refractory Multiple Myeloma

This research is being done to determine if the combination of the Dendritic Cell (DC)/ Multiple Myeloma (MM) fusion vaccine with elranatamab is safe and effective in treating Relapsed or Refractory Multiple Myeloma (MM).
The names of the study drugs and vaccine involved in this study are:
* DC/MM fusion vaccine (a personalized cancer vaccine in which harvested participant tumor cells are fused with harvested participant dendritic blood cells)
* Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) (a type of growth factor)
* Elranatamab (a type of T-cell engager antibody)

Start Date01 Apr 2025

Sponsor / Collaborator

Beth Israel Deaconess Medical Center, Inc.

[+1]

100 Clinical Results associated with Elranatamab

100 Translational Medicine associated with Elranatamab

100 Patents (Medical) associated with Elranatamab

Literatures (Medical) associated with Elranatamab

01 Apr 2025·Clinical Lymphoma Myeloma & Leukemia

Expert Opinion on Multiple Myeloma Treatment in Brazil in the Bispecific Antibody Era

Review

Author: Pericole, Fernando Vieira ; Sanku, Gayatri ; Pinto Neto, Jorge Vaz ; Hungria, Vania ; Filho, Roberto Jose Pessoa de Magalhães ; Maiolino, Angelo ; Garibaldi, Pedro Manoel Marques ; Jansen, Angela Marie

Multiple myeloma treatment has evolved rapidly with the development of novel targeted therapies. The paper outlines multiple myeloma epidemiology, current treatments, and recent advances, highlighting the role of bispecific antibodies. Brazilian authorities have approved 3 bispecific antibodies (teclistamab, elranatamab, and talquetamab) for relapsed/refractory multiple myeloma patients who have received at least three prior therapies. These therapies have shown promising efficacy in clinical trials, with 61%-74% overall response rates. However, access to these treatments varies significantly between Brazil's private and public healthcare systems. A panel of 6 Brazilian experts in multiple myeloma and bispecific antibody therapy convened for a three-day virtual conference organized and moderated by Americas Health Foundation. They addressed key questions regarding bispecific antibody therapy in multiple myeloma and developed consensus recommendations. While bispecific antibodies offer new hope for multiple myeloma patients, challenges remain in ensuring equitable access to these therapies. The paper discusses the sequencing of bispecific antibodies with other treatments, the management of adverse events, and the need for real-world data. It also highlights the disparities in multiple myeloma treatment between Brazil's public and private healthcare systems, emphasizing the need for targeted efforts to bridge this gap and improve outcomes for all multiple myeloma patients.

01 Mar 2025·Targeted Oncology

Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma

Article

Author: Lon, Hoi-Kei ; Viqueira, Andrea ; Elmeliegy, Mohamed ; Vandendries, Erik ; Wang, Diane ; Hibma, Jennifer ; Piscitelli, Joseph ; Skoura, Athanasia ; Hickman, Anne ; Soltantabar, Pooneh ; Jiang, Sibo ; Irby, Donald ; Conte, Umberto

BACKGROUND:

Elranatamab is a BCMA-CD3 bispecific antibody approved for the treatment of relapsed or refractory multiple myeloma. Cytokine release syndrome is one of the most common adverse events associated with bispecific antibodies.

OBJECTIVE:

We aimed to determine the optimal elranatamab dosing regimen for mitigating cytokine release syndrome.

PATIENTS AND METHODS:

Safety, pharmacokinetics, and exposure-response were analyzed across four clinical studies (MagnetisMM-1, MagnetisMM-2, MagnetisMM-3, and MagnetisMM-9). Different priming regimens evaluated across these studies included a one-step-up dose priming regimen of 44 mg with or without premedication, a two-step-up dose priming regimen of 12 mg on day 1 and 32 mg on day 4 with premedication, and a two-step-up dose priming regimen of 4 mg on day 1 and 20 mg on day 4 with premedication.

RESULTS:

The maximum elranatamab serum concentration on day 1 was positively associated with any-grade and grade ≥ 2 cytokine release syndrome. A slower time to maximum serum concentration and a lower dose-normalized maximum serum concentration were observed with subcutaneous versus intravenous administration, supporting subcutaneous dosing to help mitigate cytokine release syndrome.

CONCLUSIONS:

Based on the incidence, severity, and predictable profile of cytokine release syndrome, the 12/32-mg priming-dose regimen with premedication was determined to be the optimal regimen before the first full dose of 76 mg on day 8.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifiers: NCT03269136, NCT04798586, NCT04649359, and NCT05014412.

01 Feb 2025·SEMINARS IN HEMATOLOGY

Advancements in bispecific antibodies for multiple myeloma: What's new and what lies ahead

Review

Author: Mouhieddine, Tarek H ; Costa, Bruno Almeida ; Richter, Joshua

Recent advancements in multiple myeloma (MM) treatment-including immunomodulatory drugs, proteasome inhibitors, monoclonal antibodies, and T cell-redirecting therapies like chimeric antigen receptor (CAR) T cells and bispecific antibodies (BsAbs)-have significantly improved patient outcomes. However, MM remains incurable, highlighting the need for novel therapeutic strategies. BsAbs, which simultaneously target a tumor-specific antigen and CD3 on T cells, have shown promising efficacy. Three BsAbs - teclistamab, elranatamab, and talquetamab - have been approved for relapsed or refractory MM, demonstrating response rates of 60 %-74 % and median progression-free survival of approximately 1 year. This review provides a comprehensive overview of the latest advancements in BsAb therapy for MM, focusing on new therapeutic targets such as BCMA, GPRC5D, and FcRH5, recent clinical trial data, safety considerations, and future directions. We discuss tumor-intrinsic mechanisms of resistance, including antigen expression variability and antigen escape, as well as immune-related factors like T-cell exhaustion and an immunosuppressive microenvironment. Future strategies involve integrating BsAbs earlier in treatment, combining them with other agents to enhance efficacy and overcome resistance, and optimizing administration protocols to mitigate adverse effects. By examining these developments, we highlight how BsAbs are reshaping the treatment landscape of MM and underscore the importance of ongoing research to improve survival and quality of life for patients.

News (Medical) associated with Elranatamab

21 Jan 2025

·www.biospace.com

Reframing Multiple Myeloma: From Fatal to Chronic and Even Curable

iStock/ Mohammed Haneefa Nizamudeen Traditionally carrying a dire prognosis, the treatment paradigm for multiple myeloma is changing, with CAR T therapies, bispecifics and more contributing to multifaceted regimens unique to each patient’s needs. Open any medical textbook and you’ll read that multiple myeloma is incurable. However, recent advancements by Johnson and Johnson, Bristol Myers Squibb and more are shifting the paradigm to something a lot more manageable, providing new hope for the 25,000 U.S. patients diagnosed with the blood cancer each year. “[Multiple myeloma] has not been considered curable, but I think times are changing,” Saad Usmani, a myeloma specialist at Memorial Sloan Kettering Cancer Center, told BioSpace . “We are starting to call myeloma a chronically managed condition.” When Usmani started in the space 15 years ago, survival for multiple myeloma was an average of two to three years following diagnosis. Now, he said, some patients are living 15–20 years or more as treatment options have advanced and expanded. With CAR T cell therapies, antibody-drug conjugates and monoclonal, bispecific and trispecific antibodies plus other drug classes both on the market and in development pipelines, there is a growing variety of treatments to fit the unique biology of each patient’s needs—ultimately reaching for the ever-elusive cure. J&J leads the way in this space. Half of all new medicines approved for multiple myeloma have come from the company and its partners, according to Mark Wildgust, vice president of global medical affairs at J&J. But with the multiple myeloma market projected to reach $38 billion by 2034, there is plenty of room for other companies—including BMS and Pfizer—to gain strong footholds in the market. The Multiple Myeloma Market J&J’s top seller, Darzalex, is a CD38-targeted monoclonal antibody injected subcutaneously as a monotherapy or as a component of a patient’s multifaceted regimen. As of December, the drug was on track to rake in $12 billion in 2024. Sanofi is looking for a similar blockbuster in its anti-CD38 therapy Sarclisa, which was just approved in September. In addition to Darzalex, J&J markets CAR T therapy Carvykti and bispecific antibodies Tecvayli and Talvey. The company also has a novel trispecific antibody in the pipeline, for which Wildgust said it expects data this summer. Meanwhile, BMS sells CAR T therapy Abecma alongside three immunomodulators, Revlimid, Thalomid and Pomalyst, a portfolio it scooped up in its $74 billion buyout of Celgene in 2019. It also markets Empliciti, a monoclonal antibody developed with AbbVie. In competition with Tecvayli and Talvey, Pfizer sells Elrexfio, which targets BCMA CD3. Regeneron also has a BCMA CD3-targeted bispecific, linvoseltamab, in development. In a Phase III trial, treatment with the candidate elicited a 46% complete response rate with 92% of those patients s negative for minimal residual disease after 12 months. Linvoseltamab was denied FDA approval in August 2024 due to third-party issues with its manufacturing site and Regeneron is currently awaiting another inspection. While the market may seem crowded, not all of these products are in direct competition, as many are approved for different lines of treatment and diverse patient populations. In July 2024, Darzalex was approved for frontline treatment, joining proteasome inhibitors from Takeda and Amgen. Sanofi’s Sarclisa is also approved for patients newly diagnosed with the disease. CAR T therapies, on the other hand, can be used only after at least one treatment has failed, since the FDA greenlit Carvykti in the second line in April 2024. At the same time, the regulator approved Abecma in the third line, while bispecifics are still approved only for patients who have received at least four prior lines of therapy. Such a range of options is valuable because when it comes to multiple myeloma, experts agree that a multifaceted treatment regimen is key. “There is no golden bullet that will address any cancer,” Usmani said. “You will have a strategy that attacks the cancer with different components.” CAR Ts, bi- and trispecifics, antibody-drug conjugates, proteosome inhibitors, cereblon modifying agents and steroids each manipulate the immune system and target cancer in different ways. “It’s like being a cook. We’re working on how to best put them together in sequence to get the desired outcome that we need—the recipe,” Usmani said. And the recipe may be different depending on the type of myeloma, which is a heterogeneous disease with multiple molecular subgroups. The recipe could also depend on the age of the patient, he added, as multiple myeloma predominantly affects older people. Even if CAR T therapy ultimately becomes a first-line treatment, the regimen would begin with a combination of chemo-immunotherapies to bring the disease level down by 80-90%, Usmani said. Then, the CAR T would “come and clean the rest of it up.” CAR T Cell Therapies: Carvykti vs. Abecma While Darzalex may be the current money-maker for J&J, Wildgust emphasized the value of CAR T cell therapy Carvykti. “If you were to look at the singular most efficacious myeloma product developed at Johnson & Johnson, I think it’s Carvykti,” he told BioSpace . CAR T cell therapy involves extracting a patient’s own T cells and genetically modifying them in a lab to recognize and destroy cancer cells—in Carvykti and Abecma’s case, BCMA-expressing cells. Carvykti, co-developed by Legend Biotech, is in competition with BMS and 2seventy Bio’s Abecma. However, the therapies are not necessarily considered equals by practitioners. “I’m always hesitant to comment on efficacy in the absence of head-to-head data, but this is a clear case where I think even BMS would admit their product’s performance is inferior to Carvykti,” Ran Reshef, a professor of medicine and clinical lead for the CAR T Cell program at Columbia University Irving Medical Center, said during a recent William Blair investor call, adding that real-world data clearly shows Carvykti’s superiority. However, in an email to BioSpace , a BMS spokesperson said, “Data comparisons from separate trials investigating Abecma or Carvytki in certain patients with multiple myeloma are not appropriate, as each trial has different patient populations, study designs, and treatment comparators.” Carvykti and Abecma could soon have new competition from Gilead Sciences and partner Arcellx, which in November 2024 touted strong response rates and promising survival outcomes from a registrational Phase II trial of anitocabtagene autoleucel in patients with relapsed or refractory multiple myeloma. While there have been concerns and reports of delayed neurotoxicity among patients taking the therapies, particularly Carvykti, Reshef said this has not precluded him from using them in treatment. However, this has reframed the conversation, helping patients to understand the risk of potential long-term side effects that may not be reversible. So far, none of his patients have declined the therapy due to the risk. “Carvykti is the only [CAR T] that’s proven a survival benefit,” Wildgust said, adding that J&J is “figuring out” how to manage the safety concerns associated with the drug. Beyond survival benefit, CAR T therapies are at the forefront of the “treat to cure” mission, Wildgust said. He referenced a study conducted in China showing that five years after one dose of Carvykti, about 21% of patients were still alive without disease progression. J&J’s CARTITUDE-1 study is expected to read out this summer, providing a five-year progression-free survival rate. “My anticipation is, we’re going to see a proportion of those patients are indeed cured,” Wildgust said. A Shift in Expectations With these treatment advances comes a shift in expectations for patients and providers alike. In April 2024, for example, an FDA advisory committee agreed that minimal residual disease (MRD) could be a viable surrogate endpoint in place of survival for accelerated drug approval in multiple myeloma. With patients surviving for longer periods of time, it has become impractical for companies to follow trials through to a survival readout. “It’s a fancier way of measuring how deep the response is to treatment,” Usmani said. “If patients achieve MRD negativity, they get better progression-free survival, which is a surrogate for overall survival.” There’s also the possibility of prevention on the horizon, as J&J is now targeting high-risk smoldering myeloma with Darzalex. Smoldering myeloma is an early stage of the disease in which abnormal plasma cells have begun to build up in the bone marrow, but without noticeable symptoms. It’s often found incidentally in a patient’s bloodwork. About half of smoldering myeloma cases with high-risk features will develop into active myeloma within two years, Wildgust said. “Historically, patients with smoldering myeloma are watch and wait,” he said. “Actually, the patients will tell you it’s watch and worry. Watch and be scared.” That could soon change. In a Phase III trial presented last month at the American Society of Hematology’s annual meeting, treating high-risk smoldering myeloma patients with Darzalex reduced the risk of disease progression or death by 51% versus active monitoring. The need for first-line treatment was also reduced by 42% in the Darzalex group compared to the monitored group. J&J has filed applications with both the FDA and European Medicines Agency to make Darzalex the first-ever treatment option for smoldering myeloma. While it remains to be seen whether Darzalex becomes a preventive option for high-risk patients, both Usmani and Wildgust are optimistic that a cure for some multiple myeloma patients may be near. “I think that this is an amazing time to be a myeloma investigator, trying to figure out how to develop strategies that get us to that functional curability in this older patient population,” Usmani said. Meanwhile, J&J has undertaken the “audacious” mission to cure 50% of patients with myeloma, and “I don’t think we’re as far away from that as we might think,” Wildgust said. “I want a red pen, and I want to go find every medical textbook and cross out incurable because that’s where we’re going.”

Drug ApprovalClinical ResultPhase 3ImmunotherapyPhase 2

05 Dec 2024

·www.businesswire.com

Pfizer Showcases Scientific Leadership in Breast Cancer and Blood Disorders Across More than 100 Presentations at ASH and SABCS

NEW YORK--( BUSINESS WIRE )--Pfizer Inc. (NYSE: PFE) will highlight the latest advancements from its growing hematology and breast cancer portfolios at the American Society of Hematology (ASH) Annual Meeting & Exposition (December 7-10) and the San Antonio Breast Cancer Symposium (SABCS, December 10-13). Data from more than 100 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 13 oral presentations and four poster spotlights, will be shared across the company’s approved medicines and expanding portfolio of potential breakthroughs for patients with blood and breast cancers, as well as rare blood disorders. “ Our robust presence at ASH and SABCS reinforces Pfizer’s legacy of scientific innovation for people living with blood disorders and breast cancer,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. “ We are pleased to share the latest updates for some of our key approved medicines, including ADCETRIS, ELREXFIO, and IBRANCE, which continue to generate compelling data as foundations of care in their respective indications. We are also excited to present new results in hemophilia and from our expanding pipeline of innovative, next-generation therapy candidates for both blood and breast cancers, including new data on combination approaches across our core scientific modalities.” Key ASH Presentations Data from more than 75 company-sponsored, investigator-sponsored, and collaborative research abstracts will be presented at ASH, including updated analyses from the pivotal ECHELON-3 trial supporting the clinical benefit of ADCETRIS ® (brentuximab vedotin) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). New data for ELREXFIO ® (elranatamab-bcmm) in relapsed/refractory multiple myeloma (RRMM) will also be presented from the pivotal MagnetisMM-3 trial, as well as Phase 1 combination data from the MagnetisMM-20 trial. Pfizer will also present updates from its growing Hematology-Oncology pipeline, which includes next-generation CD30 antibody-drug conjugates and other novel and differentiated molecules, including the first presentation of combination data for SEA-CD70 in high-risk myelodysplastic syndromes. Additionally, Pfizer will present results across its portfolio of investigational and approved medicines in benign hematology. ADCETRIS: Additional analyses from the Phase 3 ECHELON-3 trial will be presented, highlighting the durability of complete responses and consistent benefit of ADCETRIS in combination with lenalidomide and rituximab in patients with relapsed/refractory DLBCL, including enrollment of elderly patients, those who are refractory to most recent treatment, and those who have received prior CAR-T therapy. These findings also underscore the overall survival (OS) advantage over lenalidomide and rituximab plus placebo in patients who have received at least two prior lines of therapy. In addition, updated two-year follow-up data from a Phase 2 study investigating the combination of ADCETRIS, nivolumab, doxorubicin, and dacarbazine in newly diagnosed early-stage classical Hodgkin lymphoma (cHL) will be presented highlighting promising efficacy and safety of this investigational novel combination. ELREXFIO: A post hoc analysis of the Phase 2 MagnetisMM-3 trial continues to show deep and durable responses after longer-term follow-up of nearly three years, and these responses were also maintained with a reduction to once-monthly dosing in RRMM. Data will also be shared from the ongoing Phase 1b MagnetisMM-20 trial that indicate encouraging clinical efficacy and predictable safety signals with ELREXFIO in combination with carfilzomib and dexamethasone after a median of two prior lines of therapy (range: one to three). SEA-CD70 (PF-08046040): Encouraging preliminary data from the ongoing Phase 1 study with PF-08046040, also known as SEA-CD70, a nonfucosylated monoclonal antibody targeting CD70 that is designed to enhance effector function, will be shared for the first time from the combination dose-optimization cohort with azacitidine in patients with higher-risk myelodysplastic syndromes (MDS). SEA-CD70 is being developed with the goal of being a best-in-class foundational medicine either alone or as combination treatment in myeloid malignancies. Key SABCS Presentations Data from 30 company-sponsored, investigator-sponsored, and collaborative research abstracts will be presented at SABCS, including nine real-world analyses affirming IBRANCE ® (palbociclib) as a first-line standard-of-care treatment for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The company will also present new data from its expanding pipeline of innovative, next-generation therapy candidates that have the potential to address critical unmet patient needs across all subtypes and stages of breast cancer, including new and updated Phase 1 data for atirmociclib, vepdegestrant, and the novel KAT6 inhibitor, PF-07248144. IBRANCE : In P-VERIFY, the largest-ever real-world comparative overall survival analysis of first-line CDK4/6 inhibitors plus aromatase inhibitor (AI) therapy in HR+/HER2- MBC, numerically similar overall survival rates were observed across CDK4/6 inhibitor groups at 12, 24, and 30 months. Atirmociclib (PF-07220060): Updated data will be presented from a Phase 1/2a study of atirmociclib, a next-generation, highly selective CDK4 inhibitor, in combination with letrozole as a potential first-line treatment for patients with HR+/HER2- MBC. Atirmociclib is being developed as a potential future CDK inhibitor backbone therapy in HR+ MBC, and a Phase 3 study in the first-line setting is anticipated to start by early 2025. Vepdegestrant: For the first time, initial Phase 1b data will be shared from the Phase 1b/2 TACTIVE-U trial evaluating the combination of vepdegestrant, a potential first-in-class PROteolysis TArgeting Chimera (PROTAC) estrogen receptor (ER) degrader, in combination with abemaciclib in patients with ER+/HER2- locally advanced or MBC. These data reinforce the potential of vepdegestrant as a new backbone endocrine therapy, and Pfizer and Arvinas anticipate topline Phase 3 data evaluating vepdegestrant as a monotherapy in the first quarter of 2025. KAT6 (PF-07248144) : Updated efficacy and safety data will be presented from a Phase 1 dose-expansion study of PF-07248144, a novel KAT6 inhibitor, in heavily pretreated ER+/HER2- MBC. These early data continue to provide strong clinical proof of concept for this novel target as a potential new treatment approach for ER+/HER2- MBC, and Pfizer anticipates initiating a Phase 3 study for PF-07248144 in the post-CDK4/6 inhibitor setting in mid-2025. Additional information on key Pfizer-sponsored abstracts at ASH and SABCS, including date and time of presentation, follow in the chart below. A complete list of Pfizer-sponsored accepted abstracts is available here: https://www.pfizer.com/ASH_and_SABCS_2024_Sponsored_Abstracts . Blood Cancers Updated Analysis of Brentuximab Vedotin, Nivolumab, Doxorubicin, and Dacarbazine for Nonbulky, Early-Stage Classical Hodgkin Lymphoma (Abstract #460) Abramson J Oral Presentation Sunday, December 8, 9:30-11:00 AM PST Presentation Time: 10:15 AM PST Efficacy of Elranatamab (ELRA) in Combination with Carfilzomib (CFZ) and Dexamethasone (DEX) in the Phase 1b MagnetisMM-20 Trial in Relapsed or Refractory Multiple Myeloma (RRMM) (Abstract #1024) Tomasson MH Oral Presentation Monday, December 9, 4:30-5:30 PM PST Presentation Time: 5:15 PM PST PF-08046040 (SEA-CD70), a Nonfucosylated CD70-Directed Antibody, in Combination with Azacitidine for Patients with Myelodysplastic Syndromes (MDS): A Phase 1 Dose-Finding and Dose Expansion Study (Abstract #1840) Poster Presentation Saturday, December 7, 5:30-7:30 PM PST Durability of Complete Responses in Patients from the ECHELON-3 Study (Abstract #3101) Yasenchak C Poster Presentation Sunday, December 8, 6:00-8:00 PM PST MagnetisMM-3: Long-Term Update and Efficacy and Safety of Less Frequent Dosing of Elranatamab in Patients with Relapsed or Refractory Multiple Myeloma (Abstract #4738) Prince M Poster Presentation Monday, December 9, 6:00-8:00 PM PST Outcomes in Older Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study (Abstract #4483) Bartlett N Poster Presentation Monday, December 9, 6:00-8:00 PM PST Outcomes by Refractory Status and Prior Therapies Received in Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) from the ECHELON-3 Study (Abstract #4489) Hahn U Poster Presentation Monday, December 9, 6:00-8:00 PM PST Hemophilia Efficacy and Safety of Giroctocogene Fitelparvovec in Adults with Moderately Severe to Severe Hemophilia Α: Primary Analysis Results from the Phase 3 AFFINE Gene Therapy Trial (Abstract #1053) Leavitt AD Oral Presentation Monday, December 9, 4:30-6:00 PM PST Presentation Time: 5:00 PM PST Descriptive Characterization of Bleeding Events in Participants with Severe Hemophilia Α or B without Inhibitors, Receiving Prophylactic Marstacimab Treatment (Abstract #716) Matino D Oral Presentation Monday, December 9, 10:30 AM-12:00 PM PST Presentation Time: 10:45 AM PST Sickle Cell Disease Qualitative Interview Study to Characterize the Treatment Experiences of Participants with Sickle Cell Disease and Assess Perceptions of Red Blood Cell Transfusions (Abstract #3691) Kosa K Poster Presentation Sunday, December 8, 6:00-8:00 PM PST Breast Cancer Comparative overall survival of CDK4/6is plus an aromatase inhibitor (AI) in HR+/HER2- MBC in the US real-world setting Rugo et al Poster Spotlight Presentation (PS2-03) Thursday, December 12, 7:00-8:30 AM CST PF-07248144, a first-in-class KAT6 inhibitor, in patients with HR+ HER2− metastatic breast cancer: Updated results from phase 1 dose expansion study Mukohara et al Poster Presentation (P4-10-28) Thursday, December 12, 5:30-7:00 PM CST Vepdegestrant, a PROteolysis TArgeting Chimera (PROTAC) Estrogen Receptor (ER) Degrader, Plus Abemaciclib in ER-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced or Metastatic Breast Cancer: TACTIVE-U Preliminary Phase 1b Results Hilton et al Poster Presentation (P4-12-03) Thursday, December 12, 5:30-7:00 PM CST The next-generation CDK4-selective inhibitor atirmociclib (PF-07220060) in combination with letrozole as first-line treatment in patients with HR+/HER2+ metastatic breast cancer Giordana et al Poster Presentation (P5-07-28) Friday, December 13, 12:30-2:00 PM CST About Pfizer Oncology At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics. We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives. About Pfizer Rare Disease There are over 10,000 known rare diseases that affect approximately 400 million people worldwide. 80% of these diseases have genetic origins and 50% affect children. Collectively, people living with a rare disease represent one of the largest underserved patient communities in the world, with less than 10% of known rare diseases having one or more approved treatments. At Pfizer, we believe that people living with a rare disease, along with the untold number of family members and caregivers who support them, deserve more. For more than 40 years, we have provided critical treatment options for patients with rare diseases including 11 Pfizer Rare Disease medicines that have received regulatory approval. Prescribing Information for Pfizer Medicines Please read full Prescribing Information , including BOXED WARNING, for ADCETRIS. Please read full Prescribing Information , including BOXED WARNING, for ELREXFIO. Please read full Prescribing Information for HYMPAVZI. Please see full Prescribing Information for IBRANCE ® (palbociclib) tablets and IBRANCE ® (palbociclib) capsules . About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of healthcare products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with healthcare providers, governments, and local communities to support and expand access to reliable, affordable healthcare around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer_News , LinkedIn , YouTube , and like us on Facebook at www.facebook.com/Pfizer/ . Disclosure notice The information contained in this release is as of December 5, 2024. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s hematology and breast cancer portfolio and pipeline, ADCETRIS (brentuximab vedotin), ELREXFIO (elranatamab-bcmm), SEA-CD70 (PF-08046040), IBRANCE (palbociclib), atirmociclib (PF-07220060), vepdegestrant, and the novel KAT6 inhibitor, PF-07248144 , including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s breast cancer and hematology products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any applications may be filed with any regulatory authorities for any potential indications for brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any other product candidates; whether and when any applications that may be pending or filed for brentuximab vedotin, elranatamab-bcmm, PF-08046040 or any such other product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any such other product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of brentuximab vedotin, elranatamab-bcmm, PF-08046040, palbociclib, PF-07220060, vepdegestrant, and PF-07248144, or any such other product candidates; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “ Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com .

Phase 1Clinical ResultPhase 2Phase 3Immunotherapy

03 Dec 2024

·www.prnewswire.com

Imre Welcomes Haifa Barbari and Joe Macera, Reinforcing the Agency's Momentum as Healthcare AOR of Choice

Senior Leader Additions Deepen Excellence in Strategy and CreativeNEW YORK, Dec. 3, 2024 /PRNewswire/ -- Imre welcomes two new leaders reinforcing its Strategy and Creative functions as it continues to focus on deepening its healthcare agency-of-record engagements. Haifa Barbari joins in the new role of Executive Vice President of Strategy and Customer Experience, along with Senior Vice President, Group Creative Director of Copy, Joe Macera. Continue Reading Imre Welcomes Haifa Barbari and Joe Macera, Reinforcing the Agency’s Momentum as Healthcare AOR of Choice "We're excited to welcome Haifa and Joe to the Imre team," said Anna Kotis, President. "Haifa's strategic expertise in global healthcare and her drive for innovation align perfectly with our mission to deliver impactful, future-focused solutions. Joe's proven creative leadership in launching major health campaigns strengthens our ability to craft resonant narratives for both healthcare professionals and patients. These two leaders will be instrumental in advancing the work we do for our client partners." Haifa Barbari, an award-winning strategist and futurist with 18 years of global experience, specializes in health, tech, and emerging markets. She has worked across the UK, US, and Asia-Pacific with pharma, health tech, startups, and nonprofits, creating unified brand and customer experience strategies. Passionate about solving business problems, Haifa thrives in uncertain environments and is eager to collaborate on innovative solutions. As EVP of Strategy and Customer Experience at Imre, she will lead and enhance the agency's strategic offerings connecting behavior change with the impact of AI. She'll co-create how we bring mutual meaning and value to our clients and the rising empowered patient and HCP, and build programs and services that impact healthcare, one brand and experience at a time. "We're living through unprecedented change, and I'm excited to join Imre at this pivotal time to bring my expertise in health, tech, and emerging trends, to strategically partner with our clients, and guide how to win in market now, and future proof their business," said Barbari. "I'm excited to partner with the team to reimagine creative and engagement approaches, driving progress for our clients in an ever-evolving world."Additionally, Joe Macera joins the agency with more than 12 years of healthcare advertising experience. Through his career, Macera has crafted impactful campaigns across oncology, cardiology, CNS, and infectious diseases, leading major launches for brands such as Pfizer's Elrexfio, Novartis' Entresto, and Sanofi/Regeneron's Praluent. At Imre, he will leverage his experience to tackle challenges with innovative solutions and guide creative strategy."I'm honored to join Imre and collaborate with a team of leaders I greatly admire," said Macera. "It's exciting to be part of an agency driven by shared values and a clear vision. I look forward to supporting our creative team, fostering inclusivity, and helping expand our portfolio of healthcare AOR experience, creating meaningful work that impacts healthcare professionals and patients." About Imre: Imre is a brand engagement agency that reaches people at pivotal moments through modern communications, new technologies and cutting-edge creativity. Imre works with many of the world's leading companies and high-growth brands. Driven by innovation and rooted in earned and social media, the agency's integrated suite of marketing communications services includes brand strategy, creative, omnichannel marketing, modern earned and paid media and data and analytics. Imre partners with a diversified and growing portfolio of healthcare and consumer organizations. The agency maintains offices in New York, Baltimore, and Philadelphia in addition to a group of employees who work from anywhere. Imre is an LGBTQ-founded company. SOURCE imre WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Executive Change

100 Deals associated with Elranatamab

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KEGG	Wiki	ATC	Drug Bank
D12058	-	-	DB15395

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Pfizer Inc.	14 Aug 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapse multiple myeloma	Phase 3	United States	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Japan	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Argentina	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Belgium	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Brazil	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Canada	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Czechia	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Denmark	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	Finland	Pfizer Inc.	08 Feb 2024
Relapse multiple myeloma	Phase 3	France	Pfizer Inc.	08 Feb 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024 Manual	Not Applicable	Multiple Myeloma	-	Teclistamab	bftpgleows(atmjdnllka) = ayafpgvhpl dpshtfigrv (ejufztduqs ) View more	Positive	09 Dec 2024
				Elranatamab	bftpgleows(atmjdnllka) = ogulggxngb dpshtfigrv (ejufztduqs ) View more
ASH2024 Manual	Not Applicable	Immunoglobulin Light-Chain Amyloidosis	3	Elranatamab	ibmrlwynfm(pjwqohofdt) = Two patients developed CRS, and all were grade 2. CRS occurred within 24 hours of the first priming dose, lasted two days, and resolved with IV fluids, tocilizumab, and dexamethasone without recurrence sqakopnoov (zhrnttblwt ) View more	Positive	08 Dec 2024
ASH2024	Not Applicable	Relapse multiple myeloma	-	Linvoseltamab	mbicbgglif(pefhqnupzu) = rohlrfhoft kuqirdugqf (gbulagedvu )	-	07 Dec 2024
				Teclistamab	mbicbgglif(pefhqnupzu) = udnujupdrj kuqirdugqf (gbulagedvu )
NCT04798586 (CTgov)	Phase 1	Multiple Myeloma	4	Elranatamab	sblsuinxef = rsjphytyqx cndookzujy (ghopnaxwcf, aviunnemlf - eslojygewz) View more	-	27 Sep 2024
NCT05228470 (CTgov)	Phase 1/2	Multiple Myeloma \| Refractory Multiple Myeloma	39	C1D1+elranatamab (Phase 1b)	pbowwucmaf = uheywjvaed zvxaijgtzp (ocbwjiqvir, wcnynqgzou - pwvmfwzkef) View more	-	19 Sep 2024
				C1D1+elranatamab (Phase 2)	cdteqcroyy = ejnzkudfvh pldxxvkmcm (hondywrgre, wzkrtyioak - pcuoqgrscm) View more
MM-466 (SOHO2024)	Not Applicable	Refractory Multiple Myeloma BCMA	6	Elranatamab 76 mg QW	acoenzgkag(uldnxthefq) = txqkedzrae bpeqdeekrp (bshgpgvbnf ) View more	Positive	04 Sep 2024
NCT04649359 (MagnetisMM-3, EHA 12024 \| EHA 22024) Manual	Phase 2	Refractory Multiple Myeloma Second line \| Last line	123	Elranatamab (2-3 prior LOTs)	uxjbdhefcm(plpbrovful) = kjxidfdzkw kafqhklqqy (thltrqglvi ) View more	Positive	13 Jun 2024
				Elranatamab (≥4 prior LOTs)	uxjbdhefcm(plpbrovful) = aejjvvmmbi kafqhklqqy (thltrqglvi ) View more
NCT05014412 (MagnetisMM-9, ASCO2024)	Phase 1/2	Multiple Myeloma BCMA-CD3	85	ELRA 4/20 mg step-up priming regimen	nsxfffaxat(itfzwwydfd) = xeesbqmhjx adioiboupr (izurcmdyks ) View more	Positive	24 May 2024
NCT05014412 (MagnetisMM-9, EHA2024) Manual	Phase 1/2	Multiple Myeloma BCMA \| CD3	85	Elranatamab	ocxdbisski(ejcuncellw) = ukqspztvvn uyccunnerg (ucqhpuuqkg, 8.4 - 21.9) View more	Positive	14 May 2024
				ELRA 76 mg once weekly	ocxdbisski(dhlawjwnhk) = tonerydtre rmrygqvoqr (liwrexyysl ) View more
EHA2024 Manual	Phase 2	Multiple Myeloma del(17p)	101	Elranatamab 12 mg	uaoiqtfbup(hbrrgyoppe) = jmevhzpbdb sjogxmzaac (imqdwppjup ) View more	Positive	14 May 2024

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