RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (Australia)

Structure/Sequence

Sequence Code 166136L

Source: *****

Sequence Code 10219401H

Source: *****

293

Clinical Trials associated with Avelumab

NCT05687721

/ Not yet recruitingPhase 1/2IIT

A Phase II Trial With Copanlisib Plus Avelumab as a Maintenance Therapy for Metastatic Bladder Cancer After Platinum-based Chemotherapy

Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

Start Date02 Jun 2025

Sponsor / Collaborator

VA Office of Research and Development

[+1]

NCT06939036

/ RecruitingPhase 1/2

A Multicentre, Open-label, Phase I/II Study Investigating the Safety, Tolerability, and Preliminary Efficacy of 225Ac-SSO110 in Participants With Extensive Stage Small Cell Lung Cancer (ES-SCLC) or Merkel Cell Carcinoma (MCC) Receiving Standard of Care (SoC)

This study aims to determine safety, tolerability, recommended phase 2 dose (RP2D), and preliminary antitumor activity of 225Ac-SSO110 with standard of care (SoC) therapy in patients with somatostatin receptor 2 expressing (SSTR2+) extensive-stage small cell lung cancer (ES-SCLC) and recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).

Start Date01 Apr 2025

Sponsor / Collaborator

Ariceum Therapeutics GmbH

NCT06869473

/ RecruitingPhase 2IIT

A Single-arm Phase II Study of Cetuximab Plus Platinum and Taxane-based Chemotherapy Followed by AVElumab and Cetuximab as First-line Therapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) Patients With PD-L1 Combined Positive Score (CPS)≥1≤19: the Immunotherapy Sequenc

This phase II interventional clinical trial aims to evaluate whether combining cetuximab and avelumab, after three cycles of platinum and taxane-based chemotherapy, can improve treatment outcomes for patients with recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) with a PD-L1 combined positive score (CPS) between 1 and 19. Specifically, the study seeks to determine if this approach can increase the 6-month progression-free survival (PFS) rate from 40% to 55%.
The trial will include adult patients with confirmed R/M HNSCC, who have not previously received systemic therapy for their advanced disease. By testing this sequential treatment strategy, researchers hope to improve outcomes for this specific patient population, which has shown poorer responses to existing immunotherapy options compared to those with higher PD-L1 expression levels.
Participants will first undergo an induction phase, consisting of three cycles of chemotherapy with paclitaxel, platinum (cisplatin or carboplatin), and cetuximab. After this initial treatment, they will move to a maintenance phase, where they will receive avelumab and cetuximab every two weeks until disease progression or the occurrence of unacceptable side effects.
The study aims to answer several key questions:
Can this treatment approach improve progression-free survival at 6 months? What impact does it have on overall survival, response rates, and the duration of response? Is this combination therapy safe and well-tolerated? In addition to the treatment itself, participants will be asked to provide blood and tumor tissue samples for translational research, helping scientists better understand how biomarkers influence treatment response. Regular follow-up assessments will also be conducted to monitor disease progression and overall health.
By testing this innovative treatment sequence, researchers hope to bridge the gap between different PD-L1 subgroups, potentially offering a more effective and personalized approach for patients with R/M HNSCC.

Start Date20 Feb 2025

Sponsor / Collaborator

Gruppo Oncologico del Nord-Ovest

[+2]

100 Clinical Results associated with Avelumab

100 Translational Medicine associated with Avelumab

100 Patents (Medical) associated with Avelumab

1,135

Literatures (Medical) associated with Avelumab

31 Dec 2025·OncoImmunology

Avelumab induces greater Fc-Fc receptor-dependent natural killer cell activation and dendritic cell crosstalk compared to durvalumab

Article

Author: Makarov, Vladimir ; Srivastava, Raghvendra M ; Rupani, Amit ; Chan, Timothy A ; Osborne, Nicole

Several FDA-approved anti-PD-L1 (programmed cell death ligand-1) monoclonal antibodies (mAbs) are used to treat cancer. While these mAbs primarily target and intercept PD-L1:PD-1 inhibitory signaling in T-cells, the Fc-domains of these mAbs are distinct, and the unique cellular cascades triggered by differing Fc-domains of PD-L1 mAbs have not been directly investigated. In this study, we compared the innate immune effects of two widely used anti-PD-L1 IgG1 mAbs which bear distinct Fc-domains, avelumab (native-Fc) and durvalumab (mutated-Fc), using two-cell and three-cell co-culture systems containing Natural Killer cells (NK-cells), dendritic cells (DCs) and various tumor cell lines of multiple cancer origins. We show a robust enhancement in NK-cell effector function, DC maturation, reciprocal NK:DC crosstalk and DC editing that is unique to avelumab treatment using multiple functional immune assays. By transcriptomic analysis, we show for the first time pivotal differences in gene sets involved in NK-cell effector function, DC maturation, immunoregulatory interactions, and cytokine production between innate immune cells treated with avelumab versus durvalumab. Furthermore, we report several previously unknown Fc-receptor-associated biological pathways uniquely triggered by avelumab. Our findings elucidate novel mechanisms of Fc-dependent actions of PD-L1 mAbs which may inform their use in future clinical trials.

01 Jul 2025·GYNECOLOGIC ONCOLOGY

Phase 2, two-stage study of avelumab and axitinib in patients with mismatch repair proficient recurrent or persistent endometrial cancer

Article

Author: Fleming, Gini F ; Zhou, Ningxuan ; Xiong, Niya ; Sawyer, Hannah ; Matulonis, Ursula A ; Cheng, Su-Chun ; Moroney, John ; Konstantinopoulos, Panagiotis A ; Yeku, Oladapo ; Bouberhan, Sara ; Smith, Josephine ; Liu, Joyce F ; Penson, Richard T ; Shea, Meghan ; Rodig, Scott J ; Wright, Alexi A ; Hayes, Martin ; Lee, Elizabeth K ; Krasner, Carolyn ; Pfaff, Kathleen L ; Koppermann, Lani ; Campos, Susana ; Jones, Stephanie ; Stover, Elizabeth H ; Castro, Cesar ; Porter, Rebecca ; Polak, Madeline

OBJECTIVE:

Combinations of immune checkpoint inhibitors (ICIs) and antiangiogenic agents have demonstrated potent clinical activity across multiple tumor types. We hypothesized that the combination of axitinib, a highly potent inhibitor of VEGFR1-3, with the anti-PD-L1 antibody avelumab would be well tolerated and effective in the treatment of recurrent MMRP EC.

METHODS:

We conducted an investigator-initiated, single-arm phase 2 study of avelumab/axitinib in MMRP EC (NCT02912572). Eligible participants had recurrent EC of any histology that was MMRP, measurable disease, no upper limit of prior therapies and no prior ICI treatment. Co-primary endpoints were objective response rate (ORR) and progression-free survival rate at 6 months (PFS6). Targeted next-generation sequencing and multiplexed immunofluorescence were performed.

RESULTS:

Thirty-five patients initiated protocol therapy. There were 14 objective responses (ORR 40 %, 95 % CI 23.9 %-57.9 %), including 1 confirmed CR, 1 unconfirmed CR, 8 confirmed PRs, and 4 unconfirmed PRs. Thirteen patients (37.1 %) had stable disease (SD), and 6 (17.1 %) patients had progressive disease (PD). The confirmed objective response rate (ORR) was 25.7 % (95 % CI 12.5 % to 43.3 %), estimated median DOR was 13.8 months, PFS at 6 months was 55.8 %, and the estimated median PFS was 7 months. The most common G3+ treatment-related toxicities were hypertension (37.1 %), ALT increased (5.7 %) and AST increased (5.7 %); 5 (14.3 %) patients discontinued protocol therapy because of toxicity. Objective response rate was 48 % in TP53 mutated tumors and 28.6 % in NSMP tumors.

CONCLUSIONS:

Avelumab and axitinib had an acceptable safety profile and demonstrated encouraging activity in recurrent MMRP EC.

01 Jun 2025·Laryngoscope Investigative Otolaryngology

Association of Sinonasal Symptoms and Disease With Immune Checkpoint Inhibitor Therapy

Article

Author: Gao, Jaynelle ; Hur, Kevin ; Chwa, Jason ; Chung, Ryan S.

ABSTRACT:

Background:

Immune checkpoint inhibitors (ICIs) are widely used for cancer therapy and are associated with immune‐related adverse events (irAEs) in various organ systems. However, data on sinonasal irAEs remain limited. This study investigates the association between ICI therapy and sinonasal conditions, including chronic rhinosinusitis (CRS) and nasal polyps, using a national health database.

Methods:

This retrospective cohort study utilized the TriNetX US Network to analyze adults diagnosed with malignant neoplasms for which ICIs are an accepted treatment option. Patients treated with FDA‐approved ICIs (pembrolizumab, nivolumab, cemiplimab, atezolizumab, durvalumab, avelumab, or ipilimumab) were compared to those not receiving ICIs. Exclusion criteria included sinonasal neoplasms and prior sinus surgery. Propensity score matching on age, race, sex, and asthma diagnosis was performed. Outcomes included first‐time diagnoses of CRS, nasal polyps, and cardinal symptoms of CRS. Subgroup analyses by ICI mechanism of action and a post hoc analysis of all‐cause mortality were conducted.

Results:

ICI therapy was associated with a decreased likelihood of CRS diagnosis (OR 0.90, 95% CI 0.85–0.96), nasal polyp diagnosis (OR 0.65, 95% CI 0.51–0.83), and facial pain (OR 0.74, 95% CI 0.56–0.99). Conversely, patients receiving ICIs had an increased likelihood of anosmia/parosmia or parageusia (OR 1.86, 95% CI 1.68–2.07), and rhinorrhea (OR 1.16, 95% CI 1.10–1.22). Subgroup analyses supported these findings across different ICI categories. Risk of mortality was higher among ICI‐treated patients (HR 4.09, 95% CI 4.02–4.16).

Conclusion:

This is the first propensity‐matched study to evaluate the relationship between ICI therapy and sinonasal conditions, revealing a decreased risk of CRS and nasal polyps in patients undergoing ICI therapy. Future studies are needed to explore the clinical significance and mechanism of ICI‐related sinonasal symptoms.

Level of Evidence:

355

News (Medical) associated with Avelumab

27 May 2025

·www.einpresswire.com

Vaccinex to Report Promising New Clinical Results of Neoadjuvant Treatment with Pepinemab to Enhance Immunotherapy in Patients with Head and Neck Cancer at ASCO Annual Meeting

Neoadjuvant treatment with pepinemab appears to induce abundant, mature lymphoid structures that correlate with improved pathologic response. ROCHESTER, N.Y., May 27, 2025 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies in the neoadjuvant setting that are associated with improved pathologic response in patients with head and neck cancer . Lead investigator and collaborator, Conor Steuer, MD from Winship Cancer Center at Emory University, will present results at the 2025 Annual Meeting of Clinical Oncology (ASCO) in Chicago on June 1, 2025 . ASCO Conference Information: Date: Sunday, June 1, 2025 Presentation title: Neoadjuvant biomarker trial of pepinemab to enhance nivolumab or ipilimumab activity in resectable head and neck cancer. Abstract 103. Time: 9:45-11:15 AM CST/10:45 AM – 12:15 PM EST. Session Title: Clinical Science Symposium – Turning “Cold” Tumors “Hot” Previously reported data from our collaboration with Emory University suggest a crucial role of pepinemab treatment in melanoma patients to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS . By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses. New data presented at ASCO will characterize the mechanisms of neoadjuvant treatment with pepinemab in patients with resectable head and neck cancer (HNSCC). Standard of care for these patients often involves toxic chemotherapy and/or radiotherapy, in addition to surgery, which can significantly impact their quality of life. Peri-operative treatment with immunotherapy has recently reported promising and potentially practice-changing results. Certain HNSCC with hot beds of immune cells organized into TLS have been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. However, many HNSCC are considered immunologically “cold” tumors, due to exclusion of immune cells from tumor and/or high levels of immune suppressor cells, making them resistant to immune checkpoint therapy. Pepinemab has potential to be a major advance for HNSCC patients with cold and resistant disease , with capacity of a well-tolerated and effective treatment that can induce formation and harness the power of TLS to optimize the clinical benefit of immunotherapy. Our data demonstrate that the addition of pepinemab to neoadjuvant immune checkpoint treatments did not compound toxicities, yet it enhanced TLS maturity that correlated with improved pathologic response. Collectively, these results highlight the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative head and neck cancer, into hot immune centers by inducing robust and mature TLS. About Pepinemab Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications. About Vaccinex Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes prevents infiltration and activation of immune cells in tumors and triggers damaging inflammation in neurodegenerative diseases. In oncology, pepinemab is also being evaluated in combination with KEYTRUDA ® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO ® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. We believe pepinemab has also given promising results as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data suggesting a slowing of cognitive decline in Huntington’s disease. Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO ® /avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 and SIGNAL-AD clinical trials; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA ® or BAVENCIO ® ; expectations with respect to the collaboration of Merck,; and other statements identified by words such as “anticipate,” “believe,” “plans,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “promising,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our previous reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s 2024 year-end Form 10-K filed with the SEC. Investor Contact Elizabeth Evans, PhD Chief Operating Officer Senior Vice President, Vaccinex, Inc. (585) 271-2700 eevans@vaccinex.com Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

ImmunotherapyASCOPhase 2Clinical Result

27 May 2025

·ir.vaccinex.com

Vaccinex to Report Promising New Clinical Results of Neoadjuvant Treatment with Pepinemab to Enhance Immunotherapy in Patients with Head and Neck Cancer at ASCO Annual Meeting | Vaccinex, Inc.

ROCHESTER, N.Y., May 27, 2025 (GLOBE NEWSWIRE) -- Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and Alzheimer’s disease (AD) through the inhibition of Semaphorin 4D (SEMA4D), today announced that it will present new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies in the neoadjuvant setting that are associated with improved pathologic response in patients with head and neck cancer. Lead investigator and collaborator, Conor Steuer, MD from Winship Cancer Center at Emory University, will present results at the 2025 Annual Meeting of Clinical Oncology (ASCO) in Chicago on June 1, 2025. ASCO Conference Information: Previously reported data from our collaboration with Emory University suggest a crucial role of pepinemab treatment in melanoma patients to facilitate immune cell interactions within highly organized and robust centers of immunity, called tertiary lymphoid structures, or TLS. By blocking the SEMA4D inhibitory signal to Dendritic Cells (DC), pepinemab allows productive, coordinated interactions between SEMA4D+ T cells, key effector cells capable of eradicating tumors, and DC, regulatory cells that promote immune cell interactions within TLS so as to amplify mature T cell responses. New data presented at ASCO will characterize the mechanisms of neoadjuvant treatment with pepinemab in patients with resectable head and neck cancer (HNSCC). Standard of care for these patients often involves toxic chemotherapy and/or radiotherapy, in addition to surgery, which can significantly impact their quality of life. Peri-operative treatment with immunotherapy has recently reported promising and potentially practice-changing results. Certain HNSCC with hot beds of immune cells organized into TLS have been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. However, many HNSCC are considered immunologically “cold” tumors, due to exclusion of immune cells from tumor and/or high levels of immune suppressor cells, making them resistant to immune checkpoint therapy. Pepinemab has potential to be a major advance for HNSCC patients with cold and resistant disease, with capacity of a well-tolerated and effective treatment that can induce formation and harness the power of TLS to optimize the clinical benefit of immunotherapy. Our data demonstrate that the addition of pepinemab to neoadjuvant immune checkpoint treatments did not compound toxicities, yet it enhanced TLS maturity that correlated with improved pathologic response. Collectively, these results highlight the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative head and neck cancer, into hot immune centers by inducing robust and mature TLS. About Pepinemab Pepinemab is a humanized IgG4 monoclonal antibody designed to block SEMA4D, which can otherwise bind to plexin-B1 receptors to trigger collapse of the actin cytoskeleton and lead to loss of homeostatic functions of dendritic cells in immune tissue and of astrocytes and other glial cells in the brain. Pepinemab appears to be well-tolerated with a favorable safety profile in multiple clinical trials in different cancer and neurological indications. About Vaccinex Inc. Vaccinex, Inc. is pioneering a differentiated approach to treating cancer and slowly progressive neurodegenerative diseases through the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent biological effector that it believes prevents infiltration and activation of immune cells in tumors and triggers damaging inflammation in neurodegenerative diseases. In oncology, pepinemab is also being evaluated in combination with KEYTRUDA® in the Phase 1b/2 KEYNOTE-B84 study in recurrent or metastatic head and neck cancer (HNSCC) and in combination with BAVENCIO® in a Phase 1b/2 study in patients with metastatic pancreatic adenocarcinoma (PDAC). The oncology clinical program also includes several investigator-sponsored studies in solid tumors including breast cancer and melanoma. We believe pepinemab has also given promising results as a monotherapy in the Phase 1b/2 SIGNAL-AD study in Alzheimer’s Disease, and the Company has previously published promising Phase 2 data suggesting a slowing of cognitive decline in Huntington’s disease. Vaccinex has global commercial and development rights to pepinemab and is the sponsor of the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA. BAVENCIO®/avelumab is provided by Merck KGaA, Darmstadt, Germany, previously as part of an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer. Forward Looking Statements To the extent that statements contained in this press release are not descriptions of historical facts regarding Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Such statements include, but are not limited to, statements about our plans, expectations and objectives with respect to the results and timing of the KEYNOTE-B84 and SIGNAL-AD clinical trials; the use and potential benefits of pepinemab in R/M HNSCC, lung cancer, metastatic pancreatic adenocarcinoma (PDAC) and other indications; the potential for benefits as compared to single agent KEYTRUDA® or BAVENCIO®; expectations with respect to the collaboration of Merck,; and other statements identified by words such as “anticipate,” “believe,” “plans,” “schedule,” “being,” “will,” “appears,” “expect,” “ongoing,” “potential,” “promising,” “suggest”, and similar expressions or their negatives (as well as other words and expressions referencing future events, conditions, or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the outcome of our research and pre-clinical development programs, clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials, that interim and preliminary data may not be predictive of final results and does not ensure success in later clinical trials, uncertainties related to regulatory approval, risks related to our dependence on our lead product candidate pepinemab, and other matters that could affect our development plans or the commercial potential of our product candidates. Except as required by law, the Company assumes no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section titled “Risk Factors” in our previous reports filed with the Securities and Exchange Commission and the other risks and uncertainties described in the Company’s 2024 year-end Form 10-K filed with the SEC. Source: Vaccinex, Inc.

ImmunotherapyASCOPhase 2Clinical Result

15 May 2025

·www.fiercepharma.com

Merck KGaA cites Trump tariffs, funding cuts as it scales back 2025 contracting forecast

Merck KGaA now expects sales from its life science arm—which provides R&D and CDMO services, plus key materials for partners—to land between 8.8 billion euros and 9.4 billion euros in 2025. As has been the case for several quarters now, Merck KGaA’s life science business continues to serve as a weathervane for the broader biopharma industry.For the full year, Merck now expects sales from its life science arm—which provides R&D and CDMO services plus key materials for partners—to land between 8.8 billion euros and 9.4 billion euros.The decision to scale back from a previous forecast of 9.1 billion euros to 9.8 billion euros can be blamed in large part on the “current uncertainties around tariffs,” Merck said in a Thursday press release.“In response to the challenging global backdrop, we've slightly adjusted our guidance but continue to remain confident that we are well-positioned to achieve sustainable growth for 2025 and beyond,” the company’s CEO, Belén Garijo, said in a statement.Production aside, contract research work suffered in the first quarter as well, with Merck attributing the decline in an earnings presentation (PDF) to "U.S. policy changes impacting U.S. academic and government labs spending."While tariffs form a major piece of the second Trump administration’s trade policy, much-feared duties on pharmaceuticals were exempted in a large tariff rollout last month. Still, the administration continues to stress that sector-specific trade penalties remain on the table.In turn, some drugmakers like Merck KGaA have baked potential tariff threats into updated guidance ranges for the year. Meanwhile, leaders at certain biopharma outfits like Eli Lilly, Bristol Myers Squibb and Johnson & Johnson have come out with direct criticism of President Donald Trump’s trade policy and the unintended consequences it could have on U.S. healthcare.While pharmaceutical-specific tariffs have yet to touch down, Merck KGaA has already had to factor trade duties into its operations this year by adding a surcharge to life science orders for customers in China.Still, Merck KGaA got some relief on that front this week after the U.S. and China agreed to temporarily scale back their dueling tariffs, Reuters reported Wednesday. In the wake of that announcement, Merck discontinued the temporary surcharge for China-based customers.Merck KGaA also revised its overall 2025 guidance down to a range of 20.9 billion euros ($23.4 billion) to 22.4 billion euros ($25 billion), citing a challenging political and economic environment plus currency exchange fluctuations.The company had previously expected to generate total sales between 21.5 billion euros and 22.9 billion euros in 2025.Over the first three months of the year, Merck’s overall net sales climbed 2.5% to 5.3 billion euros ($6 billion) compared to the same quarter in 2024. The company's healthcare sector grew sales 3.4% to 2.1 billion euros ($2.34 billion), which Merck KGaA credited to strong performances in its cardiovascular, metabolism and endocrinology segments. While certain medications like cancer drug Erbitux and multiple sclerosis treatment Mavenclad enjoyed sales boosts in the quarter, other former big earners, such as carcinoma med Bavencio, continued to flounder.Bavencio—which won its original FDA nod in Merkel cell carcinoma 2017—suffered a more than 15% sales decline to 157 million euros ($176 million) in the first quarter. In an earnings breakdown, Merck attributed Bavencio’s ongoing fall from glory to steep North American competition in bladder cancer. In a bid to boost its foothold in oncology, Merck KGaA late last month announced a deal to purchase cancer-focused Pfizer spinout SpringWorks Therapeutics for $3.9 billion. The health of Merck KGaA’s life science business has frequently reflected the broader challenges facing the industry in recent quarters, although, prior to the tariff threat, many of the issues Merck’s earnings brought to light revolved around contract development and manufacturing.While Merck, like many in the business, has struggled to grow its CDMO unit following the contracting heights of the COVID-19 pandemic, the company began to telegraph a turnaround for the unit last spring.In its latest earnings presentation, Merck suggested the modest life science growth it witnessed in the first quarter—carried by a process solutions boost—helps validate its thesis that the business unit overall is recovering.

AcquisitionFinancial Statement

100 Deals associated with Avelumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10817	Avelumab	L01XC31	DB11945

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Renal Cell Carcinoma	Australia	Merck Healthcare Pty Ltd.	03 Jan 2018
Advanced Renal Cell Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Advanced Renal Cell Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Locally Advanced Urothelial Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	European Union	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Metastatic Merkel Cell Carcinoma	Norway	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	European Union	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Iceland	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Liechtenstein	Merck Europe BV	18 Sep 2017
Metastatic urothelial carcinoma	Norway	Merck Europe BV	18 Sep 2017
Transitional Cell Carcinoma	United States	EMD Serono, Inc.	09 May 2017
Merkel Cell Carcinoma	United States	EMD Serono, Inc.	23 Mar 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	United States	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Japan	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Argentina	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Australia	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Belgium	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Brazil	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Bulgaria	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Czechia	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	France	Merck KGaA	22 Mar 2019
Solid tumor	Phase 3	Germany	Merck KGaA	22 Mar 2019

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03047473 (SEJ, CTgov)	Phase 2	Glioblastoma Multiforme	38	avelumab	dxiaremcbz = tsrctrbami ubbdfjjpcq (bnsidselyp, fwaofmurze - gvoultbdql) View more	-	25 May 2025
Phase 2 trial (AACR2025)	Phase 2	Advanced Urothelial Carcinoma MTAP-deficiency	15	Pemetrexed	uzxesbdofz(ujqryrqanp) = xaovzmfcfp zetdevnkrh (kpnzvuednn, 23% - 71%) View more	Positive	28 Apr 2025
NCT04322643 (CTgov)	Phase 2	Advanced Urothelial Carcinoma \| Urothelial Carcinoma of the Urinary Bladder	4	Nivolumab+Avelumab+Atezolizumab+pembrolizumab+Durvalumab	krpvnbfyjv = jjzjzsejlf bixlrccsfp (zenfwjyaqr, pabxwihgvy - clddzajjib) View more	-	25 Feb 2025
ASCO_GU2025 Manual	Not Applicable	Advanced Renal Cell Carcinoma First line	-	Avelumab + Axitinib	wxaoiotdvv(yughbkeuiu) = fpqlwyhqds gkqquvzlwg (hgwjinkpga ) View more	Positive	13 Feb 2025
JAVELIN Bladder 100 (ASCO_GU2025) Manual	Not Applicable	Advanced Urothelial Carcinoma Maintenance \| First line	106	Avelumabavelumabaintenance therapy (From avelumab initiation)	eojrbdjhrl(itrpdscgks) = tesoxkltvz hjrbhretlu (vjoseizktd, 11.6 - 23.4) View more	Negative	13 Feb 2025
				Avelumab 1L maintenance therapy (the start of 1L PBC in this population without disease progression after 1L PBC)	eojrbdjhrl(itrpdscgks) = jdcagjnwth hjrbhretlu (vjoseizktd, 17.0 - 28.9)
ASCO_GU2025 Manual	Not Applicable	Transitional Cell Carcinoma First line \| Maintenance	107	Avelumab 1L maintenance treatment	wbanrpdigy(pwdcatfqvh) = Not reached jjcnyhqfro (thdakwfsnz )	Positive	13 Feb 2025
NCT03891238 (ARIES, ASCO_GU2025) Manual	Phase 2	Advanced Urothelial Carcinoma First line	71	Avelumab	sqkvjoaddd(ircduxtxvo) = mwbbcamgco bkkduqpmsl (vreatzpadm, 5.3 – 15.3) View more	Positive	13 Feb 2025
				Avelumab (liver mets)	sqkvjoaddd(ircduxtxvo) = acyxcrfzec bkkduqpmsl (vreatzpadm ) View more
NCT04698213 (Tide-A, ASCO_GU2025) Manual	Phase 2	Metastatic Renal Cell Carcinoma First line \| Maintenance	75	avelumab plus intermittent axitinib	fqekbewsuv(sfhihcnccq) = bhudviwemz yykbzohavr (xbjhiuxnll ) View more	Positive	13 Feb 2025
				avelumab plus intermittent axitinib (interrupted Axi at W36)	fqekbewsuv(sfhihcnccq) = pjgsbkkang yykbzohavr (xbjhiuxnll ) View more
JAVELIN Bladder 100 (ASCO_GU2025)	Phase 3	Advanced Urothelial Carcinoma Maintenance	453	Gemcitabine + Cisplatin (GC)	qrjobmdmvh(urnzbhjpze) = Median OS was not reached in any subgroup; the 1-year OS rate was 77.9% (95% CI, 73.7-81.5) overall, and 79.6% (95% CI, 74.3-84.0), 73.8% (95% CI, 66.2-80.0), and 88.9% (95% CI, 43.3-98.4) in subgroups cgvpmhkzgv (sbepuppatw )	Positive	13 Feb 2025
				Gemcitabine + Carboplatin (GCa)
ASCO_GU2025	Not Applicable	Transitional Cell Carcinoma First line	290	avelumab (Nonvisceral Metastases)	aodfpzzjvs(xfejaovlkk) = myhhebyxoi ovszmiejux (ugtjjtktbv ) View more	-	13 Feb 2025
				avelumab (Visceral Metastases)	aodfpzzjvs(xfejaovlkk) = pxcshafqrr ovszmiejux (ugtjjtktbv ) View more

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