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Last update 09 May 2025

Lenalidomide

Last update 09 May 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Degradable Molecular Glue

Synonyms

1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline, 3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione, CMIO-LLD

+ [18]

Target

CK1α x CRBN x IKZF1 x IKZF3

Action

inhibitors, modulators

Mechanism

CK1α inhibitors(casein kinase 1 alpha 1 inhibitors), CRBN modulators(Cereblon modulators), IKZF1 inhibitors(DNA-binding protein Ikaros inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesCardiovascular Diseases+ [7]

Active Indication

Large B-cell lymphomaMarginal Zone B-Cell LymphomaAdult T-Cell Leukemia-Lymphoma+ [66]

Inactive Indication

Aase Smith Syndrome 2acute leukemiaAcute Lymphoblastic Leukemia+ [110]

Originator Organization

Celgene Corp.

Active Organization

Janssen Pharmaceuticals, Inc.Janssen Research & Development LLC

Incyte Corp.

+ [33]

Inactive Organization

Janssen-Cilag International NV

Cephalon, Inc.

Novartis Pharmaceuticals Corp.

+ [8]

License Organization

Xencor, Inc.

MorphoSys AG

Drug Highest PhaseApproved

First Approval Date

United States (27 Dec 2005),

Myelodysplastic Syndromes

RegulationOrphan Drug (United States), Priority Review (China), Special Review Project (China), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC13H13N3O3

InChIKeyGOTYRUGSSMKFNF-UHFFFAOYSA-N

CAS Registry191732-72-6

1,303

Clinical Trials associated with Lenalidomide

NCT06461988

/ Not yet recruitingPhase 2IIT

An Open-Label, Non-Randomized, Phase II Study to Study the Efficacy of Talquetamab (JNJ-64407564) and Lenalidomide as Post Stem Cell Transplant Maintenance in Multiple Myeloma (OPTIMMAL)

Multiple myeloma (MM) is a heterogenous plasma cell malignancy characterized by clonal proliferation of plasma cells and organ damage. Autologous transplantation with high dose chemotherapy is the standard of care in frontline treatment of eligible patients with MM.

Start Date01 Nov 2025

Sponsor / Collaborator

Stanford University

[+1]

NCT06932562

/ Not yet recruitingPhase 3IIT

A Randomized, Open-Label, Controlled Phase 3 Study of Comparing Daratumumab, Lenalidomide and Dexamethasone Induction Followed by Linvoseltamab Versus Continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients

This study is researching an experimental drug called linvoseltamab. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (transplant-ineligible).
The main purpose of this study is to compare the effect and safety of linvoseltamab with the effect and safety of the standard treatment.

Start Date01 Sep 2025

Sponsor / Collaborator

European Myeloma Network

[+1]

NCT06792825

/ Not yet recruitingPhase 2IIT

HM2023-43: A Phase 2 Trial of Tafasitamab in Combination With Lenalidomide+Rituximab in Treatment-naive Follicular Lymphoma and Marginal Zone Lymphoma

The study follows a Simon's two-stage phase II trial design to evaluate the safety and efficacy of tafasitamab added to rituximab and lenalidomide for two treatment-naïve, parallel, independent cohorts: follicular lymphoma (FL) and marginal zone lymphoma (MZ). Each cohort, FL and MZ, will be evaluated separately. This study is presented to the patient and consent is signed prior to the initiation of treatment for their primary malignancy.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Minnesota Masonic Cancer Center

[+1]

100 Clinical Results associated with Lenalidomide

100 Translational Medicine associated with Lenalidomide

100 Patents (Medical) associated with Lenalidomide

9,253

Literatures (Medical) associated with Lenalidomide

31 Dec 2025·Hematology

Review

Author: Kollsete Gjelberg, Hilde ; Dahl Hamnvik, Lars Henrik ; Sefland, Øystein ; Sandnes, Miriam ; Reikvam, Håkon ; Ktoridou-Valen, Irini ; Andersson Tvedt, Tor Henrik ; Brendsdal Forthun, Rakel

OBJECTIVES:

Myeloid neoplasms occurring after cytotoxic therapy (MN-pCT), previously termed therapy-related myelodysplastic neoplasia (MDS) or therapy-related acute myelogenous leukemia (AML), pose significant treatment challenges due to high resistance, poor chemotherapy tolerance, and relapse.

METHODS:

We present a 73-year-old woman with therapy-related AML following treatment for myxofibrosarcoma, characterized by the rare RUNX1::MECOM fusion resulting from a t(3;21)(q26;q22) chromosomal translocation. We also review the current literature regarding cases of this rare translocation.

RESULTS:

The patient, previously treated with chemotherapy and radiotherapy for sarcoma, was diagnosed with pancytopenia and hypoplastic bone marrow with increased blasts. Cytogenetic analysis confirmed RUNX1::MECOM fusion. Furthermore, we discuss the molecular mechanisms underlying MECOM rearrangements, specifically the role of the EVI1 oncogene. AML associated with MECOM rearrangements is associated with poor prognosis and resistance to conventional therapies. While allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only potential curative treatment, the high relapse rate limits its efficacy. Recent advancements in understanding the molecular drivers of MECOM-related AML suggest potential therapeutic strategies, including hypomethylating agents and novel combinations such as lenalidomide.

CONCLUSION:

this case and literature review emphasizes the importance of long-term monitoring of cancer survivors treated with cytotoxic therapies, as well as awareness of rare translocations in MN-pCT.

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Budget impact of introducing glofitamab for treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy in the United States

Article

Author: Li, Jia ; Mahmoudjafari, Zahra ; Masaquel, Anthony ; Parisé, Hélène ; Bercaw, Eric ; Bognar, Katalin ; Wang, Si-Tien

BACKGROUND:

Glofitamab is a T-cell engaging bispecific monoclonal antibody that was granted accelerated approval from the United States Food and Drug Administration for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after ≥2 lines of systemic therapy (3L+).

METHODS:

A budget impact model was developed for a hypothetical blended commercial/Medicare health plan with 1,000,000 members. Comparators were axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), loncastuximab tesirine, polatuzumab vedotin + bendamustine + rituximab, rituximab + gemcitabine + oxaliplatin, tafasitamab + lenalidomide, and epcoritamab (Epcor). Total costs included those for drugs, wastage, administration, grade ≥3 adverse reactions, and all-grade cytokine release syndrome) and routine care. Market shares were based on internal projections and expert opinions. Total and per-member per-month (PMPM) net budget impacts over 3 years were calculated.

RESULTS:

Approximately nine patients were projected to be eligible for 3L + DLBCL treatment in a health plan of 1,000,000 members. The introduction of glofitamab as a treatment option resulted in estimated total and PMPM cost savings of $728,697 and -$0.0202, respectively, over 3 years. Costs were reduced across all cost categories but particularly in drug costs. Among the newer therapies, total 3-year cost per treated patient was lowest for glofitamab: $226,658 versus Tisa-cel = $564,113; Axi-cel = $540,002; Liso-cel = $516,272; and Epcor = $335,293. Across all sensitivity analyses, the inclusion of glofitamab had minimal PMPM budget impact, ranging from -$0.0256 to -$0.0108.

CONCLUSIONS:

With the lowest 3-year total cost per treated patient among the newer therapies, glofitamab being an available option in the 3L + DLBCL market is estimated to save a hypothetical 1,000,000-member health plan $728,697 in cumulative total costs and $0.0202 in PMPM costs over 3 years.

31 Dec 2025·Hematology

Bortezomib, thalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone in transplant-eligible newly diagnosed multiple myeloma: a systemic review and meta-analysis

Review

Author: Lin, Cheng-Hsien ; Teng, Chieh-Lin Jerry ; Su, Yu-Chen ; Wang, Yin-Che

BACKGROUND:

The current study aimed to compare treatment responses, the incidence of the need for auto-HSCT, and the occurrence of specific adverse events (AEs) between VTD and velcade, VRD induction regimens in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM).

METHODS:

This systematic review and meta-analysis included 15 studies: six evaluating the VTD regimen and nine evaluating the VRD one. The primary endpoints were response rates after induction therapy and the incidence of a need for autologous hematopoietic stem cell transplantion (auto-HSCT) between the groups. We also examined the occurrence of grade 3 or 4 hematological, infection, and thrombotic AEs in both groups.

RESULTS:

The VTD group showed an overall response rate (ORR) of 93%, while the VRD group had an ORR of 86%. The very good partial response (VGPR) rates were 61% in the VTD group and 60% in the VRD one. The auto-HSCT rate was higher in the VTD group, averaging 93% compared to 70% in the VRD one. The incidence of grade 3 or 4 hematological AEs was 31% for VTD and 33% for VRD. The rates of grade 3 or 4 infection-related AEs were 9% in the VTD group and 14% in the VRD one. The incidence of grade 3 or 4 thrombotic AEs was 4% for VTD and 3% for VRD.

CONCLUSIONS:

With comparable safety profiles, VTD and VRD induction therapies are similarly effective for transplant-eligible NDMM, showing similar ORRs and VGPR rates.

881

News (Medical) associated with Lenalidomide

08 May 2025

·ir.alxoncology.com

ALX Oncology Reports First Quarter 2025 Financial Results and Provides Corporate Update

Following announcement of prioritized development strategy for evorpacept in combination with anti-cancer antibodies at R&D Day in March, Company is on track to initiate Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC studies in mid-2025 IND clearance received from U.S. FDA for novel EGFR-targeted antibody-drug conjugate (ADC), ALX2004, paving way for mid-year clinical program initiation; Company to host webcast focused on ALX2004 research program on May 20 Company will not pursue U.S. registrational path in gastric cancer following receipt of FDA feedback that accelerated approval pathway is not feasible based on ASPEN-06 due to standard-of-care evolving to ENHERTU® Data milestones expected across Company’s three clinical programs in 2026 Cash runway has been extended into Q4 2026 SOUTH SAN FRANCISCO, Calif., May 08, 2025 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc., ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today reported financial results for the first quarter ended March 31, 2025, and provided a corporate update. "In the first quarter of the year, we focused our development strategy for evorpacept on the anti-cancer antibody combinations, as we now have proof-of-concept for this mechanism in gastric cancer, breast cancer and NHL," said Jason Lettmann, Chief Executive Officer of ALX Oncology. "In addition to the evorpacept program, we diversified our pipeline by moving our in-house ADC candidate, ALX2004, through IND clearance and look forward to beginning clinical trial enrollment by mid-year for this potentially first- and best-in-class EGFR ADC. We also made the difficult but critical decision to streamline the company and, by doing so, extended cash runway into Q4 2026. We are now hyper-focused on pursuing the validated mechanism of action for evorpacept in combination with anti-cancer antibodies and delivering data in breast cancer in combination with HERCEPTIN®, in colorectal cancer in combination with ERBITUX®, as well as from ALX2004, in 2026." ALX Oncology Q1 2025 Highlights and Recent Developments Received Investigational New Drug (IND) clearance for ALX2004 from the U.S. Food and Drug Administration (FDA). ALX2004 is a potential best- and first-in-class ADC for the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors that was fully designed and developed in-house by ALX Oncology scientists utilizing the Company’s proprietary linker-payload platform. Phase 1 clinical trials of ALX2004 are expected to initiate in mid-2025, with initial safety data available in 1H 2026. ALX Oncology will host a webcast highlighting the research program, clinical progress and novel mechanism of action for ALX2004 on May 20, 2025. Continued progress with the Phase 2 ASPEN-Breast and Phase 1 ASPEN-CRC clinical studies evaluating evorpacept in combination with anti-cancer antibodies and chemotherapy in breast and colorectal cancers based on strong supporting data that, when combined with an anti-cancer antibody, evorpacept generates durable responses and a consistent safety profile. First patient dosing for both trials is anticipated mid-year 2025. The randomized Phase 2 ASPEN-Breast clinical trial will evaluate evorpacept with HERCEPTIN® (trastuzumab) and single-agent chemotherapy in patients with HER2-positive metastatic breast cancer after prior treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki). The Phase 1 ASPEN-CRC clinical trial will evaluate evorpacept with ERBITUX® (cetuximab) and FOLFIRI in patients with second-line metastatic colorectal cancer. Announced encouraging final results from the Phase 1 trial evaluating evorpacept with standard-of-care RITUXAN® (rituximab) and lenalidomide (R2) treatment in patients with B-cell non-Hodgkin Lymphoma (B-NHL) presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. The trial was conducted by Paolo Strati, M.D., Associate Professor of Lymphoma-Myeloma at The University of Texas MD Anderson Cancer Center, and colleagues at MD Anderson. As previously published, the combination of evorpacept plus R2 was well tolerated and demonstrated promising anti-tumor activity, generating complete responses (CR) in 83% of patients with indolent relapsed or refractory B-NHL comparing favorably to the 34% historical CR rate with R2 alone. The Phase 2 portion of the trial in patients with previously untreated indolent NHL is ongoing and has completed enrollment. Reported topline results from the ASPEN-03 and ASPEN-04 Phase 2 trials evaluating evorpacept with a checkpoint inhibitor, which did not meet their primary endpoints. In the trials, efficacy data did not support advancing evorpacept in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), into a registrational study. The combination of evorpacept and pembrolizumab with or without chemotherapy in ASPEN-03 and ASPEN-04 demonstrated a manageable safety profile and was consistent with what has been previously reported for pembrolizumab and chemotherapy in this setting. Received guidance from the U.S. FDA that the ASPEN-06 Phase 2 trial data evaluating evorpacept in combination with trastuzumab, ramucirumab and paclitaxel was not eligible for submission for accelerated approval given the availability of ENHERTU®. A Phase 3 versus ENHERTU® trial would be needed to pursue a regulatory approval of evorpacept in the second-line setting for HER2-positive gastric and gastroesophageal cancers. Given the Company’s disciplined focus and the allocation of its resources, ALX Oncology will not pursue a U.S. registrational path with a Phase 3 trial in gastric cancer and will consider exploring development partnerships to advance this program in gastric cancer. The Company made the decision to discontinue its evaluation of evorpacept in combination with PADCEV® (enfortumab vedotin-ejfv) in urothelial cancer based on the final data analysis showing that, in the ASPEN-07 trial, the addition of evorpacept to treatment with PADCEV® did not meet the bar for improved efficacy. Aligned to these data and consistent with recent guidance, ALX Oncology maintains its focus on continuing to progress its trials of evorpacept with anti-cancer antibodies, where there is demonstrated proof-of-concept across multiple clinical settings. Through previously announced strategic reprioritization efforts, the Company extended its cash runway into Q4 2026. Data milestones that are expected across the three studies evaluating evorpacept and ALX2004 are included in cash runway. The randomized Phase 2 ASPEN-Breast clinical trial will evaluate evorpacept with HERCEPTIN® (trastuzumab) and single-agent chemotherapy in patients with HER2-positive metastatic breast cancer after prior treatment with ENHERTU® (fam-trastuzumab deruxtecan-nxki). The Phase 1 ASPEN-CRC clinical trial will evaluate evorpacept with ERBITUX® (cetuximab) and FOLFIRI in patients with second-line metastatic colorectal cancer. As previously published, the combination of evorpacept plus R2 was well tolerated and demonstrated promising anti-tumor activity, generating complete responses (CR) in 83% of patients with indolent relapsed or refractory B-NHL comparing favorably to the 34% historical CR rate with R2 alone. The Phase 2 portion of the trial in patients with previously untreated indolent NHL is ongoing and has completed enrollment. Upcoming Clinical Milestones Breast Cancer: Patient dosing anticipated to initiate for ASPEN-BREAST Phase 2 clinical trial in mid-year 2025. Interim results from this trial are anticipated in 2H 2026. Colorectal Cancer: Patient dosing anticipated to initiate for ASPEN-CRC Phase 1b clinical trial in mid-year 2025. Safety and early efficacy data are anticipated in 1H 2026. ALX2004: Patient dosing anticipated to initiate in mid-2025, following IND clearance from the FDA in April 2025. Safety data are anticipated in 1H 2026. Breast Cancer: Topline results from Phase 1b I-SPY clinical trial of evorpacept with ENHERTU® are anticipated in 2H 2025. First Quarter 2025 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments as of March 31, 2025, were $107.0 million. The Company believes its cash, cash equivalents and investments are sufficient to fund planned operations into Q4 of 2026. Research and Development (“R&D”) Expenses: R&D expenses consist primarily of preclinical, clinical and development costs related to the development of the Company’s current lead product candidate, evorpacept, and R&D personnel-related expenses including stock-based compensation. R&D expenses for the three months ended March 31, 2025, were $23.9 million compared to $31.7 million for the prior-year period or a decrease of $7.8 million. This decrease was primarily attributable to a decrease of $7.0 million in clinical and development costs primarily due to less manufacturing of clinical trial materials to support active clinical trials for our lead product candidate, evorpacept, and a decrease in stock-based compensation expense slightly offset by increased personnel and related costs. General and Administrative (“G&A”) Expenses: G&A expenses consist primarily of administrative personnel-related expenses, including stock-based compensation and other costs such as legal and other professional fees, patent filing and maintenance fees, and insurance. G&A expenses for the three months ended March 31, 2025, were $7.9 million compared to $6.0 million for the prior year period or an increase of $1.9 million. This increase was primarily attributable to an increase in personnel and related costs. Net loss: GAAP net loss was ($30.8) million for the three months ended March 31, 2025, or ($0.58) per basic and diluted share, as compared to a GAAP net loss of ($35.6) million for the three months ended March 31, 2024, or ($0.71) per basic and diluted share. The lower net loss is primarily attributed to lower R&D expenses. Non-GAAP net loss was ($25.5) million for the three months ended March 31, 2025, as compared to a non-GAAP net loss of ($28.5) million for the three months ended March 31, 2024. A reconciliation of GAAP to non-GAAP financial results can be found at the end of this news release. About ALX Oncology ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives. ALX Oncology’s lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built. Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications. ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action and is anticipated to enter Phase 1 trials mid-2025. More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. Forward-looking statements include statements regarding future results of operations and financial position, business strategy, product candidates, planned preclinical studies and clinical trials, results of clinical trials, research and development costs, regulatory approvals, timing and likelihood of success, plans and objectives of management for future operations, as well as statements regarding industry trends. Such forward-looking statements are based on ALX Oncology’s beliefs and assumptions and on information currently available to it on the date of this press release. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause ALX Oncology’s actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. These and other risks are described more fully in ALX Oncology’s filings with the Securities and Exchange Commission ("SEC"), including ALX Oncology’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents ALX Oncology files with the SEC from time to time. Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Use of Non-GAAP Financial Measures We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered "non-GAAP" financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net loss, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP. "Non-GAAP net loss" is not based on any standardized methodology prescribed by GAAP and represents GAAP net loss adjusted to exclude stock-based compensation expense and accretion of term loan discount and issuance costs. Non-GAAP financial measures used by ALX Oncology may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies. Investor Relations Contact: Elhan Webb, CFA, IR Consultant ewebb@alxoncology.com Media Contact: Audra Friis, Sam Brown LLC audrafriis@sambrown.com (917) 519-9577

Phase 2Clinical ResultPhase 1

08 May 2025

·www.echemi.com

Big Pharma Q1 2025 Revenues Top $60B Despite Slumps in China and Generic Pressures

As patent cliffs loom and pricing scrutiny intensifies, pharmaceutical giants are doubling down on innovation pipelines and international expansion. The first quarter of 2025 saw mixed results among major players like Merck, Roche, Sanofi, Bristol Myers Squibb (BMS), and Johnson & Johnson, with several breakthrough drugs pulling weight while legacy products faltered. Merck reported $15.53 billion in total revenue, a 2% year-over-year decline, largely driven by a steep 62% drop in China sales. Its blockbuster immunotherapy Keytruda remains dominant, bringing in $7.21 billion (up 4%), nearly half of the company’s total revenue. A new subcutaneous formulation—which cuts injection time to just two minutes—is currently under U.S. and EU review. Meanwhile, Gardasil vaccine sales slid 41%, mostly due to China’s lingering stockpiles. Roche posted $17.24 billion in Q1 revenue, with pharma growing 8% to $13.34 billion. China was a highlight, showing double-digit growth. Biologics like Phesgo, Vabysmo, Xolair, and Hemlibra crossed the billion-dollar mark. The company also announced the start of a Phase III Alzheimer’s trial while axing three other pipeline projects. Sanofi’s revenue reached $10.46 billion, growing nearly 10%, led by strong U.S. performance (+15.4%). China revenues, however, slipped 1.7%. Its R&D spend was nearly $1.91 billion, funding major regulatory milestones in asthma, autoimmune, and neurodegenerative diseases, with seven pivotal trial updates expected in the second half of 2025. BMS faced a 6% decline, totaling $11.2 billion in Q1. However, its new portfolio outperformed: Opdivo, Breyanzi, and Camzyos led a 16% growth in newer therapies. The company is now forecasting up to $46.8 billion in 2025 revenue. CAR-T product Breyanzi and KRAS inhibitor Krazati were top growers, while legacy drugs like Abraxane and Revlimid fell sharply. Johnson & Johnson exceeded expectations with $21.9 billion in revenue (+2.4%). Strong gains from Darzalex, Carvykti, and Tremfya compensated for steep declines in Stelara (-34%) due to generic erosion. New combo therapies and oral biologic alternatives in late-stage development are expected to fuel momentum into 2026. From regulatory wins to strategic pipeline shifts, Big Pharma is moving fast to realign for post-patent growth. But China’s sluggish demand and trade-related tariffs will remain drag factors as the year unfolds.

VaccinePhase 3Financial Statement

07 May 2025

·www.businesswire.com

Xencor Reports First Quarter 2025 Financial Results

PASADENA, Calif.--(BUSINESS WIRE)--Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, today reported financial results for the first quarter ended March 31, 2025 and provided a review of recent business and program updates. “Recently presented interim Phase 1 results support XmAb942 as a high potency investigational anti-TL1A antibody and an every 12-week subcutaneous dosing regimen during the maintenance treatment period, which is a more convenient regimen for patients when compared to first-generation anti-TL1A antibodies. We are on track to initiate the Phase 2b XENITH-UC study of XmAb942 in ulcerative colitis later this year. We also expect to advance an XmAb TL1A x IL23p19 bispecific antibody candidate into Phase 1 in 2026,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Throughout 2025, we will continue to have a number of updates across our oncology and autoimmune pipelines.” Additionally, Nancy Valente, M.D., is retiring from her role as chief development officer (CDO) and transitioning to a senior advisor role in June 2025. Following her career in biopharmaceutical product development at Genentech, Dr. Valente was appointed to Xencor’s Board of Directors in September 2022 and then joined the management team as CDO in May 2023 to advance the Company’s clinical development strategy and organization and to lead the long-term positioning of its oncology programs. The Company’s senior leaders for oncology and autoimmune clinical development will continue in their roles and report to the CEO. “I would like to thank Nancy on behalf of the entire company for her many contributions to Xencor as a Board member and CDO. She has reshaped our clinical strategy for our oncology programs and recruited a strong team to lead the work. We are delighted she will remain active as a senior advisor and will continue to help guide us,” said Dr. Dahiyat. Recent Program Updates XmAb942 (Xtend™ TL1A): XmAb942 is a high-potency, extended half-life, investigational anti-TL1A antibody in clinical development for patients with inflammatory bowel disease (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD). The first generation of anti-TL1A antibodies have reduced disease activity in patients with UC and CD in multiple clinical studies, demonstrating the potential of this new drug class. Interim Phase 1 results for XmAb942 from a dose-escalation study in healthy volunteers were announced in April 2025. The results showed that XmAb942 was well tolerated at single and multiple doses. Pharmacokinetic analysis of the single dose cohorts estimated a human half-life of greater than 71 days, which supports a 12-week dosing interval during maintenance treatment. Xencor expects to start the XENITH-UC Study, a Phase 2b study of XmAb942 in UC, in the second half of 2025. XENITH-UC will be a randomized, double-blind, placebo-controlled trial in patients with moderate-to-severe UC, whose disease has progressed after at least one conventional or advanced therapy. XmAb TL1A x IL23p19: Xencor is conducting lead selection studies and has begun good manufacturing practice (GMP) production campaigns for a TL1A x IL-23p19 bispecific antibody, that is designed to target two important inflammatory pathways for autoimmune and inflammatory disease while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. In vitro studies show that several lead candidates match the target inhibition potency of monospecific antibodies to these targets, in a simple IgG bispecific format. Xencor anticipates initiating first-in-human studies during 2026. Recent Partnership Developments Incyte Corporation: In December 2024, Incyte announced positive full results from the pivotal study of tafasitamab in combination with lenalidomide and rituximab in relapsed or refractory follicular lymphoma and submitted a supplemental Biologics License Application, which was accepted for review by the U.S. Food and Drug Administration in February 2025. Xencor earned a $12.5 million regulatory milestone payment in addition to non-cash royalty revenue from sales of Monjuvi®/Minjuvi® for the first quarter of 2025. Monjuvi® and Minjuvi® are registered trademarks of Incyte. Vir Biotechnology, Inc.: Vir is developing tobevibart, a neutralizing antibody that uses XmAb Fc technologies, for the treatment of patients with chronic hepatitis delta (CHD) and patients with chronic hepatitis B. In March 2025, Vir initiated a Phase 3 study of tobevibart in combination for people living with CHD. We earned a $2.0 million development milestone payment from Vir for the first quarter of 2025. Additional Corporate Updates In March, Xencor appointed Todd Simpson to its board of directors. Mr. Simpson is an accomplished finance and operations executive with broad experience in corporate strategy. He has more than 40 years of experience in chief financial officer (CFO) roles at multiple biopharmaceutical companies and in public accounting, and most recently he served as CFO at Seagen through its acquisition by Pfizer in 2023. Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $535 million and $585 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028. Financial Results for the First Quarter Ended March 31, 2025 Cash, cash equivalents and marketable debt securities totaled $693.5 million as of March 31, 2025, compared to $706.7 million as of December 31, 2024. Revenue for the first quarter ended March 31, 2025 was $32.7 million, compared to $16.0 million for the same period in 2024. Revenue earned in the first quarter of 2025 was primarily non-cash royalty revenue from Alexion and Incyte and milestone revenue from Incyte and Vir, compared to the same period in 2024, which was primarily non-cash royalty revenue from Alexion and Incyte. Research and development (R&D) expenses for the first quarter ended March 31, 2025 were $58.6 million, compared to $56.9 million for the same period in 2024. Increased R&D spending for the first quarter of 2025 compared to 2024 is primarily due to increased spending on XmAb819 (ENPP3 x CD3), XmAb541 (CLDN6 x CD3) and XmAb657 (CD19 x CD3), partially offset by reduced wind-down costs on terminated programs. General and administrative (G&A) expenses for the first quarter ended March 31, 2025 were $17.3 million, compared to $13.8 million for the same period in 2024. Increased G&A spending for the first quarter of 2025 compared to 2024 is primarily due to increased spending on professional fees. Other expense, net, for the first quarter ended March 31, 2025 was $5.1 million, compared to $19.5 million for the same period in 2024. Decreased other expense, net, for the first quarter of 2025, compared to 2024, is primarily due to lower asset impairment charges. Net loss attributable to Xencor for the first quarter ended March 31, 2025 was $48.4 million, or $(0.66) on a fully diluted per share basis, compared to net loss of $73.4 million, or $(1.20) on a fully diluted per share basis, for the same period in 2024. Upcoming Investor Conferences Company management will participate at multiple upcoming investor conferences: BofA Securities Health Care Conference Date: Tuesday, May 13, 2025 Presentation Time: 6:40 p.m. ET / 3:40 p.m. PT RBC Capital Markets Global Healthcare Conference Date: Tuesday, May 20, 2025 Presentation Time: 9:00 a.m. ET / 6:00 a.m. PT Live webcasts of the presentations will be available under “Events & Presentations” in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations. About Xencor Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and autoimmune diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and multiple XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a protein’s structure that result in new mechanisms of therapeutic action. For more information, please visit www.xencor.com. Forward-Looking Statements Certain statements contained in this press release may constitute forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “indicates,” “supports,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding expectations for clinical progress, planned presentations of clinical data, new XmAb candidates and programs, planned and in process clinical trials, financial guidance, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics, the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, the risk of loss of key members of management and the risks, uncertainties and other factors described under the heading “Risk Factors” in Xencor's annual report on Form 10-K for the year ended December 31, 2024 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Xencor undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. 2025 2024 $ 420,696 $ 449,846 100,575 127,755 272,815 256,833 110,603 117,511 $ 904,689 $ 951,945 $ 88,436 $ 87,432 101,837 115,159 74,542 75,328 264,815 277,919 639,874 674,026 $ 904,689 $ 951,945 2025 2024 $ 32,732 $ 15,997 58,578 56,873 17,337 13,787 75,915 70,660 (43,183 ) (54,663 ) (5,082 ) (19,453 ) (48,265 ) (74,116 ) 367 — (48,632 ) (74,116 ) (214 ) (676 ) (48,418 ) (73,440 ) $ (0.66 ) $ (1.20 ) 73,667,179 61,212,324 1,018 (1,445 ) $ (47,614 ) $ (75,561 ) (214 ) (676 ) $ (47,400 ) $ (74,885 )

Phase 1Phase 2Executive ChangeClinical ResultFinancial Statement

100 Deals associated with Lenalidomide

External Link

KEGG	Wiki	ATC	Drug Bank
D04687	Lenalidomide	L04AX04	DB00480

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Large B-cell lymphoma	United States	Seagen, Inc.	11 Feb 2025
Marginal Zone B-Cell Lymphoma	United States	Bristol Myers Squibb Co.	28 May 2019
Adult T-Cell Leukemia-Lymphoma	Japan	Bristol-Myers Squibb KK	02 Mar 2017
Chromosome 5q Deletion Syndrome	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Chromosome 5q Deletion Syndrome	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Follicular Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Mantle-Cell Lymphoma	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	European Union	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Iceland	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Liechtenstein	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Transfusion dependent anaemia	Norway	Bristol-Myers Squibb Pharma EEIG	14 Jun 2007
Multiple Myeloma	United States	Bristol Myers Squibb Co.	29 Jun 2006

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Residual Neoplasm	Phase 3	United States	Janssen LP	13 Aug 2019
Residual Neoplasm	Phase 3	Canada	Janssen LP	13 Aug 2019
Plasmacytoma	Phase 3	United States	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	United States	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	China	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Japan	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Australia	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Belgium	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Canada	Celgene Corp.	17 Feb 2015
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type	Phase 3	Czechia	Celgene Corp.	17 Feb 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Phase 1	Relapse multiple myeloma	6	Continuous subcutaneous lenalidomide delivery	tpalmkifqj(eosfelwtzw) = bqjjezspui zzgxuparbr (ihlympndvz, 630 - 1503) View more	Positive	28 Apr 2025
NCT02523040 (CTgov)	Phase 2	Erdheim-Chester Disease \| Histiocytosis, Langerhans-Cell \| Histiocytic Sarcoma	12	Lenalidomide	vhqbuapnnx = mteoxocdna eezbskuply (plavnshdjn, rebrdicjxs - rfaztnohol) View more	-	25 Apr 2025
NCT03703167 (Pubmed \| Neuro Oncol)	Phase 1	Primary Central Nervous System Lymphoma	25	Ibrutinib 560mg	vxvchxzyvv(jyuvrqudeo) = No aspergillosis observed ulxrcoznyg (etdwjjrcmv ) View more	Positive	22 Apr 2025
NCT05788289 (CTgov)	Phase 2	Mantle cell lymphoma refractory	4	Lenalidomide+Tafasitamab	ogjvuknbvb = ipskchxxus kksdavyptb (lmbvemqbze, yhlobdbeae - heytvwaqvr) View more	-	20 Apr 2025
NCT02916771 (###DELETE \| NCT02916771, CTgov)	Phase 2	Smoldering Multiple Myeloma	55	Lenalidomide+Ixazomib+Dexamethasone	vslkquhivq = hhtldwtpoi ogzwlyaurg (uejswnwnoq, ozpwtbqtrm - kreallegqa) View more	-	05 Mar 2025
NCT04113018 (MRD-driven phase 2 study, Pubmed \| Blood Adv)	Phase 2	Multiple Myeloma next-generation sequencing-based MRD	39	Daratumumab, Carfilzomib, Lenalidomide, Dexamethasone	wptxdoqnvh(udhvmawtfz) = irzlzcpwsl hsqhtwwunz (hqgtzbxspa, 10^ - 5)	Positive	11 Feb 2025
NCT01718743 (CTgov)	Phase 2	Multiple Myeloma \| Hematopoietic stem cell transplantation	64	Questionnaire Administration+Lenalidomide+Ixazomib Citrate	jbxxtowoic(thgkaqgwst) = yxiiwoefgh nsmmoxqhoa (nquyqmotam, mztfnyueem - tcfjjucgqd) View more	-	28 Jan 2025
NCT05564052 (VEGA, CTgov)	Phase 2	Mantle cell lymphoma refractory	36	Ibrutinib+Rituximab (Arm A1: Ibrutinib 560 mg + Rituximab 375 mg/m^2)	udvgvxccbb = qesczdoene zajcyrhphl (xcbbtdlukc, qqkxmrvcxo - yyydroeaai) View more	-	13 Jan 2025
NCT05564052 (VEGA, CTgov)	Phase 2	Mantle cell lymphoma refractory	36	Ibrutinib+Rituximab (Arm A2: Ibrutinib 420 mg + Rituximab 375 mg/m^2)	udvgvxccbb = sifdumqtro zajcyrhphl (xcbbtdlukc, bknvoalfta - rrdiygwofq) View more	-	13 Jan 2025
NCT04680052 (inMIND, ASH2024) Manual	Phase 3	Follicular Lymphoma	548	Tafasitamab + Lenalidomide + Rituximab	tffalfzudr(zxuxiancko) = weyckoshwo dypcomfaml (ibpcflmipx ) View more	Positive	10 Dec 2024
NCT04680052 (inMIND, ASH2024) Manual	Phase 3	Follicular Lymphoma	548	Placebo + Lenalidomide + Rituximab	tffalfzudr(zxuxiancko) = hobnlxpmzz dypcomfaml (ibpcflmipx ) View more	Positive	10 Dec 2024
NCT03223610 (ASH2024) Manual	Phase 1/2	Mantle-Cell Lymphoma	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	kausdipsid(bedsqwxjpt) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) cxrxxdpunm (hautflnqzi ) View more	Positive	09 Dec 2024
NCT03223610 (ASH2024) Manual	Phase 1/2	Mantle-Cell Lymphoma	36	Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide		Positive	09 Dec 2024

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