Delving into the Latest Updates on Avelumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-CD274-monoclonal-antibody, Anti-PD-L1 monoclonal antibody, Avelumab (Genetical Recombination)

+ [9]

Target

PDL1

Action

inhibitors

Mechanism

PDL1 inhibitors(Programmed death-ligand 1 inhibitors)

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases+ [8]

Active Indication

Renal Cell CarcinomaAdvanced Renal Cell CarcinomaLocally Advanced Urothelial Carcinoma+ [48]

Inactive Indication

Acute Myeloid LeukemiaAcute Promyelocytic LeukemiaAdenocarcinoma of Esophagus+ [63]

Originator Organization

Merck Serono SA

Active Organization

Merck KGaA

Pfizer Inc.Merck Europe BV

+ [7]

Inactive Organization

4D Pharma Plc

Merck & Co., Inc.

Leap Therapeutics, Inc.

+ [1]

License Organization

Mendus AB (publ)

Nektar TherapeuticsMerck KGaA

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (23 Mar 2017),

Merkel Cell Carcinoma

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

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Structure/Sequence

Sequence Code 166136L

Source: *****

Sequence Code 10219401H

Source: *****

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

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100 Translational Medicine associated with Avelumab

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100 Patents (Medical) associated with Avelumab

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1,129

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 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:

3.

01 Jun 2025·EUROPEAN JOURNAL OF CANCER

Short-course radiation followed by mFOLFOX-6 plus avelumab for locally-advanced microsatellite stable rectal adenocarcinoma: The Averectal study

Article

Author: Zeidan, Youssef H ; Mohamad, Issa ; Mukherji, Deborah ; Amarin, Rula ; Deeba, Samer ; Shamseddine, Ali ; Hushki, Ahmad ; Soweid, Assaad ; Kreidieh, Malek ; Shaib, Yasser ; Alqasem, Kholoud ; Turfa, Rim ; Chehade, Laudy ; Jaber, Omar ; Khalifeh, Ibrahim ; Charafeddine, Maya ; Dabous, Ali ; Masri, Mahmoud Al ; El Husseini, Ziad ; Daoud, Faiez ; Temraz, Sally ; Jamali, Faek ; Darazi, Monita Al ; Elias, Charbel ; Doughan, Samer ; Geara, Fady ; El Khaldi, Mousa ; Kattan, Joseph ; Awabdeh, Tala Al ; Bouferraa, Youssef

BACKGROUND:

Total neoadjuvant therapy(TNT) has improved complete pathologic response (pCR) rate and disease-free survival (DFS) in locally advanced rectal cancer (LARC), though an increased local recurrence rate (LRR) with short-course radiotherapy (SCRT) is concerning. Synergism between immunotherapy and radiotherapy may improve outcomes in LARC, even where microsatellite stable (MSS) tumours exist. The Averectal trial evaluated SCRT, followed by chemotherapy and immunotherapy with avelumab and total mesorectal excision (TME) in these patients.

METHODS:

Patients with LARC received SCRT (5 Gy x5 fractions), 6 cycles of mFOLFOX-6 plus avelumab every 2 weeks, followed by TME in an investigator-initiated, open-label, single-arm, multicentre, phase II study. The primary outcome was pCR vs. historical control. Secondary outcomes were 3-year DFS, local recurrence rate (LR) and the association of the ImmunoScore (IS) with outcomes including pCR, safety, and quality of life (QoL).

RESULTS:

Out Of 44 MSS patients enrolled from 3 centres (July 2018 -October 2020), 40 completed treatment and analysed (65 % male, median age 58.5 [31.0, 74.0] years). Median follow-up was 44 months (11.4, 51.4). Fifteen patients (37.5 %) achieved pCR; and 67.5 % had a major pathologic response. Mean DFS was 42 months (37.9, 46.1). Mean OS was 46.3 months (44.4, 48.2). Median DFS and OS were not reached. Three-year DFS was 85 %. LRR was 2.5 %. Patients with vs. without pCR had higher mean IS (68 vs. 52, p = 0.036). Serious adverse events occurred in 23.5 % (one was related to avelumab). Three patients died (7.5 %), due to disease progression. QOL was similar between baseline and last follow-up.

CONCLUSION:

Adding avelumab to neoadjuvant chemotherapy mFOLFOX6 after SCRT, followed by TME, improved pCR without increasing LRR, with acceptable toxicity and QOL.

352

News (Medical) associated with Avelumab

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

13 May 2025

·www.globenewswire.com

TILT Biotherapeutics Announces Closing of USD 25 Million Series B Financing

Initiates Phase 2 platinum-resistant ovarian cancer trialHELSINKI, May 13, 2025 (GLOBE NEWSWIRE) -- TILT Biotherapeutics (Tiltbio), a clinical-stage biotechnology company developing intravenously delivered cancer immunotherapies, announces it has raised USD 25.6 million (EUR 22.6 million) in a Series B financing. The financing was supported by existing investors; the European Innovation Council (EIC) Fund, Lifeline Ventures, Finnish Industry Investment (TESI), and Stephen Industries Inc Oy. It will support a Phase 2 clinical trial of Tiltbio’s lead product, TILT-123, in patients with platinum-resistant epithelial ovarian cancer, a Phase 1b trial in melanoma in combination with TILs and other Phase 1b trials. The Company recently published data from its Phase 1a clinical trial (PROTA) in platinum-resistant ovarian cancer in Nature Communications (1), which was also presented at AACR (2). The data showed that treatment was well tolerated with an excellent safety profile and promising efficacy observed in some patients. Disease control was achieved in 64% of evaluable patients (9/14) while the overall response rate was 20% at the highest dose level. Median progression-free survival and overall survival were 98 and 190 days respectively. Interim results from ongoing Phase 1b trials are expected to read out in H2 2026. Tiltbio’s founder and CEO, Akseli Hemminki, said: “We are delighted to have secured our Series B financing and thank our investors for their continued support. We’ve been making good progress in ovarian cancer and this financing will support the roll out of our Phase 2 clinical trials. We’re excited to have already opened the first site in the USA and are looking forward to dosing our first patients soon and opening at least five more sites this year.” He continued, “Ovarian cancer continues to be an unmet medical need despite recent therapies being approved. There are no oncolytic viruses or checkpoint inhibitors currently approved for use in this indication. We are committed to our mission to transform the treatment options for patients with ovarian cancer with TILT-123.” TILT-123 (Igrelimogene litadenorepvec), an oncolytic adenovirus armed with tumor necrosis factor (TNF) and interleukin-2 (IL-2), is designed to enhance the efficacy of T-cell therapies and immune checkpoint blockade. Tiltbio has a collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318). Reference (1) Nature Communications paper: “The oncolytic adenovirus TILT-123 with pembrolizumab in platinum resistant or refractory ovarian cancer: the phase 1a PROTA trial.”(2) American Association for Cancer Research (AACR) Annual Meeting 2025 poster link: ‘Clinical immunology correlates in platinum resistant or refractory ovarian cancer patients treated with chimeric oncolytic adenovirus encoding TNF and IL-2 (TILT-123) in combination with pembrolizumab’ Notes to Editors About TILT Biotherapeutics TILT Biotherapeutics is a clinical-stage biotechnology company developing cancer therapeutics based on its proprietary oncolytic adenoviruses armed with molecules including cytokines that can activate T cells and destroy cancer cells. The company’s patented TILT® technology can be delivered intravenously, locoregionally, or intratumorally. It modifies the tumor microenvironment and has a broader systemic effect. By making cold tumors hot, it eliminates cancer’s ability to evade immune responses, thereby enhancing immune checkpoint inhibitors or T-cell therapies such as tumor infiltrating lymphocyte (TIL) and CAR T therapies. Over eighty patients have been treated in five international trials sponsored by the company with excellent safety profiles and promising initial efficacy responses observed in some patients. The company’s pioneering approach has been recognized by industry leaders. It has two collaborations with MSD (Merck & Co., Inc., Rahway, NJ, USA) investigating TILT-123 in combination with KEYTRUDA® (pembrolizumab) in ovarian cancer (NCT05271318) and in refractory non-small cell lung cancer (NCT06125197). The company is also collaborating with Merck KGaA (Darmstadt, Germany) and investigating TILT-123 in combination with Bavencio® (avelumab). Based in Helsinki, Finland, and with an office in Boston, the company was established over a decade ago as a spin-out from the University of Helsinki. To date Tiltbio has secured over EUR 72 million in financing from investors including the European Innovation Council (EIC) Fund, Lifeline Ventures, Finnish Industry Investment (TESI), Stephen Industries, angel investors, Business Finland, the EIC Accelerator programme, and the U.S. Department of Defense. Media contacts TILT Biotherapeutics COO Aino Kalervoaino@tiltbio.com Scius CommunicationsKatja Stout+447789435990katja@sciuscommunications.com Daniel Gooch+447747875479daniel@sciuscommunications.com

Phase 2Phase 1Clinical ResultImmunotherapyAACR

13 May 2025

·firstwordpharma.com

Tiltbio nabs $25M to launch mid-stage study of oncolytic virus

Tilt Biotherapeutics raised €22.6 million ($25.6 million) in a series B on Tuesday to advance its experimental oncolytic adenovirus therapy into a Phase II trial for platinum-resistant ovarian cancer (PROC). Armed with TNFα and IL-2, the adenovirus — dubbed TILT-123 — is designed to be given in combination with T cell–based therapies such as tumour-infiltrating lymphocytes (TILs) or checkpoint inhibitors to boost their efficacy. The round, which brings the Finnish biotech's total funding to over €72 million, was backed by the European Innovation Council Fund, Finnish Industry Investment, Stephen Industries Inc Oy and Lifeline Ventures; the latter led Tiltbio's €22-million financing in 2023.Combo dataThe fresh capital comes on the heels of Tiltbio's presentation at the American Association for Cancer Research (AACR) meeting last month.In the PROTA Phase I study, patients with PROC were given TILT-123 in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab). Of 14 evaluable patients, nine achieved disease control (64%); median progression-free survival was 98 days, with a median overall survival of 190 days. In the five-patient high-dose cohort, the drug duo led to an overall response rate of 20%. "Ovarian cancer continues to be an unmet medical need despite recent therapies being approved," CEO Akseli Hemminki said. "We’ve been making good progress in ovarian cancer and this financing will support the roll out of our Phase II clinical trials. We’re excited to have already opened the first site in the US and are looking forward to dosing our first patients soon and opening at least five more sites this year.”Tiltbio is exploring other cancers outside of ovarian. Tuesday's funding will help launch a Phase Ib study dosing TILT-123 in combination with TILs in patients with melanomaThe biotech is also evaluating Keytruda plus TILT-123 in patients with refractory non–small-cell lung cancer. In addition, Tiltbio previously inked a partnership with Merck KGaA to study TILT-123 with PD-L1 inhibitor Bavencio (avelumab).

Phase 2Clinical ResultPhase 1AACR

100 Deals associated with Avelumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D10817	Avelumab	L01XC31	DB11945

R&D Status

Approved

10 top approved records.

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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.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced cancer	Phase 3	United States	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Japan	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Australia	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Belgium	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Canada	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Denmark	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	France	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Hungary	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Israel	Pfizer Inc.	29 Sep 2021
Advanced cancer	Phase 3	Italy	Pfizer Inc.	29 Sep 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase 2 trial (AACR2025)	Phase 2	Advanced Urothelial Carcinoma MTAP-deficiency	15	Pemetrexed	dbckwwfwhk(xfgmtkslgv) = iipuasnccd djgvgkzvjj (yijvdxmikv, 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	fawchwxfqx = cizpntiwsy sltdjjdtwz (tqekxdpbvs, jfeoqfgdga - aqskqcfkgw) View more	-	25 Feb 2025
ASCO_GU2025 Manual	Not Applicable	Transitional Cell Carcinoma First line \| Maintenance	107	Avelumab 1L maintenance treatment	zmzpdyvthe(psoxfpphqo) = Not reached azqggnvqay (qpzmmyspie )	Positive	13 Feb 2025
NCT03891238 (ARIES, ASCO_GU2025) Manual	Phase 2	Advanced Urothelial Carcinoma First line	71	Avelumab	bmdohwwzwx(jtyigtsfpq) = yjutymqkgw wagkxfazim (oozqrxekhc, 5.3 – 15.3) View more	Positive	13 Feb 2025
				Avelumab (liver mets)	bmdohwwzwx(jtyigtsfpq) = eizcxkrgxe wagkxfazim (oozqrxekhc ) View more
JAVELIN Bladder 100 (ASCO_GU2025) Manual	Not Applicable	Advanced Urothelial Carcinoma Maintenance \| First line	106	Avelumabavelumabaintenance therapy (From avelumab initiation)	vvkmzjnfjr(vibpdkmkha) = rtapayahai etelbtstpg (yiwsluwagv, 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)	vvkmzjnfjr(vibpdkmkha) = gtuzbzniwn etelbtstpg (yiwsluwagv, 17.0 - 28.9)
ASCO_GU2025 Manual	Not Applicable	Advanced Renal Cell Carcinoma First line	-	Avelumab + Axitinib	gybxcpxqci(axfhmaamfv) = aibfekgiaf zpjjjefyxt (dfiudncoig ) View more	Positive	13 Feb 2025
NCT04698213 (Tide-A, ASCO_GU2025) Manual	Phase 2	Metastatic Renal Cell Carcinoma First line \| Maintenance	75	avelumab plus intermittent axitinib	pdjlmsydga(vmjtgebztq) = absrhqmuiv foifbporpn (rikzioqwye ) View more	Positive	13 Feb 2025
				avelumab plus intermittent axitinib (interrupted Axi at W36)	pdjlmsydga(vmjtgebztq) = moignayrtx foifbporpn (rikzioqwye ) View more
JAVELIN Bladder 100 (ASCO_GU2025)	Phase 3	Advanced Urothelial Carcinoma Maintenance	453	Gemcitabine + Cisplatin (GC)	umxvuyveih(nplimqwnuw) = 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 bxryrqricg (amvwjbgjpu )	Positive	13 Feb 2025
				Gemcitabine + Carboplatin (GCa)
ASCO_GU2025	Not Applicable	Transitional Cell Carcinoma First line	290	avelumab (Nonvisceral Metastases)	pnqronetji(fsvqkqztdh) = fdvsydhrxd siqinhywvz (ryzkutptwe ) View more	-	13 Feb 2025
				avelumab (Visceral Metastases)	pnqronetji(fsvqkqztdh) = bfpqqhvxnj siqinhywvz (ryzkutptwe ) View more
NCT04068831 (CTgov)	Phase 2	Metastatic Renal Cell Carcinoma \| Fumarate Hydratase-Deficient Renal Cell Carcinoma \| Mitochondrial Complex II Deficiency	18	Avelumab+Talazoparib (Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual))	svcftyhpvm(ppwmrstznn) = rottedyzyp szrqzypceu (xrjasoxzci, afqxaqladn - fbkkswteip) View more	-	27 Dec 2024
				Avelumab+Talazoparib (Talazoparib and Avelumab (FH- or SDH-deficiency))	svcftyhpvm(ppwmrstznn) = jcsupbvlbt szrqzypceu (xrjasoxzci, gbhuyethxc - gefxcbhrzf) View more

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Avelumab

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