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: *****

281

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

1,109

Literatures (Medical) associated with Avelumab

01 May 2025·International Journal of Clinical Oncology

The first real-world evidence on dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin followed by switch maintenance avelumab in advanced urothelial carcinoma: a propensity score-matched study

Article

Author: Tanaka, Takehiro ; Kurokawa, Yoshiaki ; Yamada, Daisuke ; Inoue, Hazuki ; Saegusa, Naoki ; Tokura, Yuumi ; Kakutani, Shigenori ; Taguchi, Satoru ; Fujii, Yoichi ; Kaneko, Tomoyuki ; Takada, Tappei ; Honda, Kazuki ; Yamamoto, Masahiro ; Kume, Haruki ; Kamei, Jun ; Nakagawa, Tohru ; Nara, Katsuhiko ; Niimi, Aya ; Yamada, Yuta ; Ambe, Yoshiki ; Kawai, Taketo ; Maki, Kazuki ; Miyakawa, Jimpei

Abstract:

Background:

Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (dd-MVAC) is an established regimen for advanced urothelial carcinoma (aUC). Although platinum-based chemotherapy, typically gemcitabine and cisplatin, followed by switch maintenance avelumab has been a recommended strategy for aUC, no study has evaluated outcomes of dd-MVAC followed by avelumab therapy.

Methods:

We reviewed 71 patients treated with first-line dd-MVAC for aUC at two university hospitals between 2018 and 2024. Overall survival (OS) and progression-free survival (PFS) were assessed as endpoints. Additionally, among patients who achieved ≥ stable disease, we performed propensity score matching between patients with and without avelumab to balance their background characteristics.

Results:

Of 71 patients, 49 (69%) experienced disease progression and 30 (42%) died during the median follow-up of 13 months. Median OS and PFS were 24 and 7 months, respectively. Among 59 patients who achieved ≥ stable disease after completion of dd-MVAC, 35 received switch maintenance avelumab, while the remaining 24 did not. After propensity score matching, patients with avelumab had significantly longer OS and PFS (both: not reached) than those without (OS: 28 months; PFS: 7 months).

Conclusions:

We herein report outcomes of dd-MVAC followed by switch maintenance avelumab in real-world patients with aUC for the first time. Avelumab therapy was significantly associated with longer survival in patients who achieved ≥ stable disease after first-line dd-MVAC. Given the excellent survival outcomes, dd-MVAC followed by switch maintenance avelumab may still be a valid option for aUC even in the new treatment paradigm as typified by enfortumab vedotin and pembrolizumab.

26 Apr 2025·JAPANESE JOURNAL OF CLINICAL ONCOLOGY

Clinical outcomes and treatment patterns of maintenance avelumab in locally advanced or metastatic urothelial carcinoma: a multicenter collaborative study

Article

Author: Urabe, Fumihiko ; Taneda, Yuki ; Yamamoto, Toshihiro ; Kayano, Sotaro ; Kimura, Takahiro ; Kawano, Shota ; Miki, Jun ; Shibata, Ken ; Hashimoto, Masaki ; Imai, Yu ; Atsuta, Mahito ; Kadena, Soshi ; Yamada, Hiroki ; Tsuzuki, Shunsuke ; Iwatani, Kosuke ; Takiguchi, Yuki ; Murakami, Masaya ; Nakazono, Minoru ; Tashiro, Kojiro ; Ohtsuka, Takashi ; Uchida, Naoki

Abstract:

Background:

The JAVELIN Bladder 100 trial demonstrated improved overall survival (OS) with maintenance avelumab in patients with locally advanced or metastatic urothelial carcinoma UC (la/mUC) who achieved disease control following first-line platinum-based chemotherapy (1 L-PBC). However, real-world data on eligibility, utilization, and outcomes of maintenance avelumab therapy remain limited.

Methods:

This retrospective study included patients with la/mUC who received 1 L-PBC. Eligibility for maintenance avelumab therapy was determined based on the best overall response to 1 L-PBC, with patients who achieved stable disease or a partial or complete response considered eligible. Survival outcomes were analyzed using the Kaplan–Meier method. Multivariate Cox regression analysis was used to identify prognostic factors among patients with la/mUC who received maintenance avelumab.

Results:

Of 161 prospective patients, 67.1% were eligible for maintenance avelumab therapy, and 46.3% of eligible patients received the treatment. The median progression-free survival (PFS) following avelumab initiation was 10.2 months, whereas the median OS was not reached. Prognostic factors associated with PFS included the presence of liver metastases, elevated C-reactive protein (> 1.0 g/dL), and administration of more than five cycles of 1 L-PBC. Adverse events occurred in 60% of patients treated with avelumab, with 16% experiencing grade 3–4 adverse events.

Conclusion:

We emphasize the real-world applicability of maintenance avelumab for Japanese patients with la/mUC. Maintenance avelumab demonstrated favorable survival outcomes, consistent with clinical trial data. Identifying prognostic factors and optimizing treatment sequencing are essential strategies for improving outcomes in this patient population.

21 Apr 2025·Future Oncology

A phase II study of lurbinectedin with or without avelumab in small cell carcinoma of the bladder (laser)—design and rationale

Article

Author: Cordes, Lisa ; Wang, Tzu-Fang ; Stukes, Ian ; Kydd, Andre R. ; Chandran, Elias ; Simon, Nicholas ; Niglio, Scot ; Boudjadi, Salah ; Atiq, Saad ; Apolo, Andrea B. ; Redd, Bernadette ; Banday, Rouf ; Smith, Elizabeth ; Patel, Ruchi ; Gurram, Sandeep ; Akbulut, Dilara ; Ley, Lisa ; Steinberg, Seth ; Girardi, Daniel

Small cell carcinoma of the bladder is a rare, aggressive malignancy accounting for less than 1% of all bladder malignancies. Treatment regimens are drawn from the small cell lung cancer (SCLC) literature, with platinum and etoposide commonly used in the first-line setting. Unfortunately, responses are generally short-lived, and most patients relapse. There is little evidence to guide selection of later lines of therapy. Lurbinectedin is an alkylating agent with accelerated US FDA approval for use in patients with SCLC. Immune checkpoint inhibitors have also been approved for SCLC, improving survival when added to chemotherapy. This article describes the design and rationale behind LASER, an open-label phase II trial of lurbinectedin with or without avelumab.Clinical trial registration: NCT06228066 (ClinicalTrial.gov).

344

News (Medical) associated with Avelumab

22 Apr 2025

·www.globenewswire.com

Vaccinex to Report Promising New Clinical Data Revealing Pepinemab’s Unique Mechanism to Enhance Immunotherapy at Annual Meeting of American Association for Cancer Research (AACR)

Neoadjuvant treatment with pepinemab appears to induce abundant, mature lymphoid structures that correlate with durable clinical benefit of immunotherapy in patients with metastatic melanoma. Pepinemab, Semaphorin 4D blocking immunotherapy, also appears to induce the formation of efficient lymphoid structures in “cold” tumors of patients with recurrent and metastatic head and neck cancer. April 21, 2025 -- 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 exciting new data characterizing the unique mechanism of pepinemab to enhance immune responses to checkpoint therapies, corresponding with improved survival benefit in patients with melanoma and head and neck cancer at the 2025 Annual Meeting of American Association for Cancer Research (AACR) in Chicago on April 29, 2025. Elizabeth Evans, PhD, Senior VP Discovery and Translational Medicine, will present results of these studies in two presentations. AACR Conference Information: Date:Tuesday, April 29, 2025 Presentation title:Regulating dendritic cells to promote mature tertiary lymphoid structures and enhance anti-tumor immunity. Presentation #3975 Time:9-12 AM CDT/10 AM – 1 PM EDT. Session Title:The Tumor Immune Interplay as a Driver of Progression Presentation title:Neoadjuvant pepinemab enhances DC function associated with mature tertiary lymphoid structures and activity of immune checkpoint blockade in patients with metastatic melanoma. Presentation #6007 Time:2-5 PM CDT/ 3-6 PM EDT. Session Title:Therapeutic Antibodies, Including Engineered Antibodies 2 Access:Posters will be presented in-person on Tuesday, April 29 at McCormick Place Convention Center, Chicago, Illinois, and on AACR 2025 virtual meeting platform at 1:00 PM ET on Friday, April 25, 2025. Previously reported data from these two clinical studies suggest a crucial role of pepinemab 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 will characterize clinical outcomes, biomarkers, and mechanisms of these interactions in patients treated with pepinemab in combination with immune checkpoint therapy. Boosting TLS within tumors is an area of growing excitement because the presence of TLS has been shown to correlate with clinical benefit and positive response to immune checkpoint therapy. A limitation in the field has been identification of safe and effective therapies that can induce formation and harness the potential of TLS to enable durable benefit to patients. Pepinemab may represent a solution to this problem, as our data demonstrate the potential of pepinemab to turn immunologically cold tumors, such as HPV-negative and PD-L1-low head and neck cancer, into hot immune centers by inducing robust and mature TLS. Neoadjuvant immunotherapy has emerged as a promising approach in the treatment of various cancers, showing improved immune and clinical benefit in the preoperative setting compared to standard post surgery adjuvant treatments. Despite these advances, many patients who initially benefit from antibodies that block inhibitory checkpoint molecules (e.g. PD-1, CTLA 4) will progress. More effective combination therapies are needed. Neoadjuvant treatment with pepinemab enhanced TLS maturity and correlated with longer recurrence-free survival when combined with immune checkpoint inhibitors in patients with metastatic melanoma. Evaluation of pepinemab in the neoadjuvant setting for patients with head and neck cancer is ongoing and will be reported at upcoming scientific meeting this Spring. 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 in cells 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. Vaccinex, Inc. is pioneering a differentiated approach to treating slowly progressive neurodegenerative diseases and cancer 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 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. The content above comes from the network. if any infringement, please contact us to modify.

ImmunotherapyAACRClinical ResultVaccine

15 Apr 2025

·pipelinereview.com

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma

LARKSPUR, CA, USA I April 14, 2025 I Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. “We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer . “Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma.” AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626 ). For patients and providers in the U.S., please visit www.solidtumorstudy.com . For patients and health professionals in Australia, please visit www.solidtumourstudy.com . About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners ( ATP ) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com , X ( @AulosBioscience ) and LinkedIn . SOURCE: Aulos Bioscience

Phase 2ImmunotherapyAACRClinical Result

14 Apr 2025

·www.businesswire.com

Aulos Bioscience Doses First Patient in Phase 2 Cohort Evaluating AU-007 in Combination With Nivolumab for Second-Line Treatment of Melanoma

LARKSPUR, Calif.--(BUSINESS WIRE)--Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of immune-activating antibody therapeutics, today announced dosing of its first patient with a combination of AU-007, the anti-PD-1 antibody nivolumab and low-dose, subcutaneous aldesleukin in a Phase 2 expansion cohort focused on second-line treatment of melanoma. This new cohort is part of Aulos’ Phase 1/2 clinical trial of AU-007 in patients with unresectable locally advanced or metastatic cancer. Preliminary Phase 2 data presented in November at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting showed that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in patients with melanoma, with durable objective responses achieved. The additional Phase 2 cohort in melanoma now allows the nivolumab combination portion of this study to progress. “We are excited that the first patient is receiving treatment in this new Phase 2 cohort evaluating AU-007 in combination with nivolumab,” said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. “Given its unique mechanism of action and the positive data presented to date on AU-007 and low-dose, subcutaneous aldesleukin, we believe that AU-007 holds real promise as a novel immuno-oncology treatment in combination with checkpoint inhibitors in multiple cancer types. These include non-small cell lung cancer, for which we initiated a Phase 2 cohort with the anti-PD-L1 antibody avelumab in November, and now melanoma.” AU-007 is the first human monoclonal antibody designed with the assistance of artificial intelligence to enter a human clinical trial. The antibody harnesses the power of interleukin-2 (IL-2) by binding precisely to the portion of IL-2 that binds to CD25, which prevents IL-2 from binding to high-affinity IL-2 receptors on Tregs, vasculature, pulmonary tissue and eosinophils. This redirects IL-2 to medium-affinity receptors on effector T cells (Teffs) and natural killer (NK) cells, which expand and kill tumor cells. Aulos anticipates presenting preliminary data from the Phase 2 cohort evaluating AU-007, nivolumab and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma in the second half of 2025. The company will present new Phase 2 data for AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor as a second-line treatment for melanoma at the American Association for Cancer Research (AACR) Annual Meeting later this month. To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com. About AU-007 AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About Aulos Aulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients’ immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos’ initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit www.aulos.com, X (@AulosBioscience) and LinkedIn.

Phase 2ImmunotherapyAACR

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
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase 2 trial (AACR2025)	Phase 2	Advanced Urothelial Carcinoma MTAP-deficiency	15	Pemetrexed	lmzffwzfwb(yveyayxfwf) = gtxvrlcsql mtqhahjahl (kaeycylaon, 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	rasnmcelkq = cijmudjekh mbjeijabrs (gkyweknrjm, dmrivcprgy - dpybponsrh) View more	-	25 Feb 2025
NCT04698213 (Tide-A, ASCO_GU2025) Manual	Phase 2	Metastatic Renal Cell Carcinoma First line \| Maintenance	75	avelumab plus intermittent axitinib	jcaslybppr(eumghevecb) = lrcplqacyu rwijhfjote (nvbjlamcou ) View more	Positive	13 Feb 2025
				avelumab plus intermittent axitinib (interrupted Axi at W36)	jcaslybppr(eumghevecb) = hiyljtsqgj rwijhfjote (nvbjlamcou ) View more
ASCO_GU2025 Manual	Not Applicable	Advanced Renal Cell Carcinoma First line	-	Avelumab + Axitinib	nebyqvjpax(rpkmvclihc) = uqdkrzuoth gufvhtysaz (sltslhxxzd ) View more	Positive	13 Feb 2025
NCT03891238 (ARIES, ASCO_GU2025) Manual	Phase 2	Advanced Urothelial Carcinoma First line	71	Avelumab	lwanzmpcty(tcklrqubmb) = kzrsimrjyt xcncomtarf (srdipcvqfi, 5.3 – 15.3) View more	Positive	13 Feb 2025
				Avelumab (liver mets)	lwanzmpcty(tcklrqubmb) = ndacyqpafd xcncomtarf (srdipcvqfi ) View more
JAVELIN Bladder 100 (ASCO_GU2025) Manual	Not Applicable	Advanced Urothelial Carcinoma Maintenance \| First line	106	Avelumabavelumabaintenance therapy (From avelumab initiation)	vxfgkososa(rptolpprda) = biqofjremp vmcwkulnha (ufyoeqlabv, 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)	vxfgkososa(rptolpprda) = ecberujszd vmcwkulnha (ufyoeqlabv, 17.0 - 28.9)
ASCO_GU2025 Manual	Not Applicable	Transitional Cell Carcinoma First line \| Maintenance	107	Avelumab 1L maintenance treatment	wuwzfpzouo(pexqiatemv) = Not reached cdrgpvszde (zghykurcvs )	Positive	13 Feb 2025
JAVELIN Bladder 100 (ASCO_GU2025)	Phase 3	Advanced Urothelial Carcinoma Maintenance	453	Gemcitabine + Cisplatin (GC)	rcddbtcmxy(yapspjsbcg) = 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 hevlycqwis (yjghsuxvmp )	Positive	13 Feb 2025
				Gemcitabine + Carboplatin (GCa)
ASCO_GU2025	Not Applicable	Transitional Cell Carcinoma First line	290	avelumab (Nonvisceral Metastases)	mrodojanvd(hjprxnkoxx) = vzlcxclueb tstslodtga (iyzapkoavz ) View more	-	13 Feb 2025
				avelumab (Visceral Metastases)	mrodojanvd(hjprxnkoxx) = hkccutwerx tstslodtga (iyzapkoavz ) 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))	voytpbakct(ndofwocmaz) = gmygbqqdei krxwqnzkma (wrkkbqpqmv, pxngbwrkvw - hdxfixwzon) View more	-	27 Dec 2024
				Avelumab+Talazoparib (Talazoparib and Avelumab (FH- or SDH-deficiency))	voytpbakct(ndofwocmaz) = yutrssqnqi krxwqnzkma (wrkkbqpqmv, soutppfpgw - uosusqnbnh) View more

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