POSTERS

European Lung Cancer Congress (ELCC) 2023

Tepotinib

1. Ferrara R, et al. Real-World Experience of MET TKI-Induced Peripheral Edema
2. Griesinger F, et al. Treatment Sequencing in the VISION Study of Tepotinib in Patients With MET Exon 14 (METex14) Skipping NSCLC

POSTERS

2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium - February 16-18, 2023 / San Francisco, CA and Virtual

Avelumab

1. Sridhar SS, et al. Avelumab First-Line (1L) Maintenance for Advanced Urothelial Carcinoma: Long-Term Follow-Up from the JAVELIN Bladder 100 Trial in Subgroups Defined by 1L Chemotherapy Regimen and Analysis of Overall Survival from Start of 1L Chemotherapy
2. Kearney M, et al. Real-World Treatment Patterns and Sequencing in Patients with Locally Advanced or Metastatic Urothelial Cancer (la/mUC) in the US
3. Tomita Y, et al. C-Reactive Protein (CRP) as a Predictive Marker for Outcomes with Avelumab + Axitinib (A + Ax) in Patients with Poor-Risk Advanced Renal Cell Carcinoma (aRCC): Exploratory Analysis from JAVELIN Renal 101
4. Grivas P, et al. Baseline Characteristics from a Retrospective, Observational, US-Based, Multicenter, Real-World Study of Avelumab First-Line Maintenance in Locally Advanced/Metastatic Urothelial Carcinoma (la/mUC) (PATRIOT-II)
5. Barthélémy P, et al. Full Analysis from AVENANCE: A Real-World Study of Avelumab First-Line Maintenance Treatment in Patients with Advanced Urothelial Carcinoma
6. Antonuzzo L, et al. READY: REAl-World Data from an Italian Compassionate Use Program of Avelumab First-Line Maintenance Treatment for locallY Advanced or Metastatic Urothelial Carcinoma (la/mUC)
7. Kirker M, et al. Assessment of Treatment Patterns and Real-World Outcomes Following Changes in the Treatment Paradigm for Locally Advanced/Metastatic Urothelial Carcinoma (la/mUC) in the US
8. Su PJ, et al. SPADE: Design of a Real-World Observational Study of Avelumab First-Line Maintenance in Advanced Urothelial Carcinoma in the Asia-Pacific Region
9. Nathan P, et al. A UK Real-World Observational Study of Avelumab + Axitinib (A + Ax) in Advanced Renal Cell Carcinoma (aRCC): 24-Month Interim Results

Other

1. Niegisch G, et al. Treatment Patterns, Indicators of Receiving Systemic Treatment, and Clinical Outcomes in Metastatic Urothelial Carcinoma: A Retrospective Analysis of Real-World Data in Germany

POSTERS

International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC)

Tepotinib

1. Le X, et al. Tepotinib with an EGFR-tyrosine kinase inhibitor in patients with EGFR-mutant MET-amplified NSCLC: A case series
2. Christopoulos P, et al. The MOMENT disease registry of patients with advanced non-small cell lung cancer harboring MET exon 14 skipping

ORAL PRESENTATIONS

International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC)

Tepotinib

1. Thomas M, et al. Tepotinib in patients with MET exon 14 skipping NSCLC: Primary analysis of the confirmatory VISION Cohort C

Avelumab

1. Reck M, et al. Avelumab vs chemotherapy for first-line treatment of advanced PD-L1+ NSCLC: primary analysis from JAVELIN Lung 100

POSTERS

American Society of Clinical Oncology (ASCO) 2022

Avelumab

1. Valderrama B, et al. Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Long-term Outcomes from JAVELIN Bladder 100 in Subgroups Defined by Response to First-line Chemotherapy (includes plain language summary)
2. Bellmunt J, et al. Long-term Outcomes in Patients with Advanced Urothelial Carcinoma who Received Avelumab First-line Maintenance with or without Second-line Treatment: Exploratory Analyses from JAVELIN Bladder 100 (includes plain language summary)
3. Liu F, et al. Evaluating Oncologists’ Practice Patterns and Decision-Making in Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC): the US Physician PARADIGM Study (part 2)

Teponitib

1. Kato T, et al. Tepotinib in Asian Patients with Advanced NSCLC with MET Exon 14 (METex14) Skipping
2. Le X, et al. Clinical Response to Tepotinib According to Circulating Tumor DNA Biomarkers in Patients with Advanced NSCLC with High-level MET Amplification Detected by Liquid Biopsy

Bintrafusp alfa

1. Oaknin A, et al. Phase 1 Trial of First-line Bintrafusp alfa in Combination with Other Anticancer Therapies in Patients with Locally Advanced or Advanced Cervical Cancer

POSTERS

American Association for Cancer Research (AACR) 2022.

Tepotinib

1. Garassino M, et al. Tepotinib Efficacy and Safety in Patients with MET Exon 14 (METex14) Skipping NSCLC
2. Jordana-Ariza N, et al. Detection of MET Alterations at the DNA, RNA and Protein Levels in NSCLC Patients Progressing on ALK and ROS1 Targeted Therapies
3. Liam CK, et al. Tepotinib + Gefitinib in Patients with EGFR-Mutant NSCLC with MET Amplification: Final Analysis of INSIGHT
4. Reischmann N, et al. MET or SHP2 Inhibition Enhances Targeted Therapies and Delays the Emergence of Resistance in Oncogene-Driven NSCLC

Xevinapant

1. Piggott L, et al. The IAP Antagonist Xevinapant in Combination with High-Dose Cisplatin Chemoradiotherapy Induces NF-κB and Apoptotic Pathway Biomarkers in Patients with High-Risk, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
2. Vugmeyster Y, et al. Selection of the Recommended Phase 3 Dose for the IAP Antagonist Xevinapant in Combination with High-Dose Cisplatin with Concurrent Radiotherapy (CRT) in Patients with High-Risk Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN)

DDRi

1. Carr M, et al. Peposertib-Induced Senescence Primes Irradiated p53 Wild-Type Cancer Cells for Clearance by both Immune Cells and Senolytic Drugs
2. Coenen-Stass AML, et al. A Novel Computational Framework Predicts Synthetic Lethal Interactions between Key Regulators of DNA Damage Response and Chromatin Modifiers
3. Zimmermann A, et al. M1774, a Novel Potent and Selective ATR Inhibitor, Shows Antitumor Effects as Monotherapy and in Combination

M1069

1. Siu LL, et al. A First-in-Human Study of the Dual A2A/A2B Adenosine Receptor Antagonist M1069 in Patients with Advanced Solid Tumors
2. Zaynagetdinov R, et al. M1069 as Dual A RESULTS 2A/ A2B Adenosine Receptor Antagonist Counteracts Immune-Suppressive Mechanisms of Adenosine and Reduces Tumor Growth In Vivo

M6223

1. Xu C, et al. Anti-Tumor Immunity and Efficacy of Combination Treatment of M6223 and Bintrafusp Alfa Versus the Combination of M6223 and Anti–PD-L1 in Preclinical Tumor Models

M1231

1. Knuehl C, et al. M1231 is a Bispecific Anti-MUC1xEGFR Antibody Drug Conjugate Designed to Treat Solid Tumors with MUC1 and EGFR Co-Expression
2. Zutshi A, et al. Translational PK/PD/Efficacy Modelling and Efficacious Human Dose Prediction for a First in Class MUC1xEGFR (M1231) Bispecific Antibody Drug Conjugate

Other

1. Abubaker K, et al. Characterization of Sub-Clonal RAS/BRAF Alterations in an Anti-EGFR Treated Advanced CRC Cohort using a Liquid Biopsy-Based Real World Clinical Genomics Database
2. Feng Z, et al. Precision Oncology-Driven Real World Clinical Genomics Data Mining of METalterations, TMB, and PD-L1 to Empower Indication Agnostic Patient Enrollment and Combination Strategies
3. Feng Z, et al. Liquid Biopsy Based Multiomics Profiling using Low Pass Whole Genome Sequencing and Proteomics with Computational Modeling Reveals Molecular Features of Disease Severity in EGFR/ALK Wildtype NSCLC Patients
4. Mrowiec T, et al. Immunohistochemistry-informed AI Systems for Improved Characterization of Tumor-Microenvironment in Clinical Non-Small Cell Lung Cancer H&E Samples
5. O'Rourke D, et al. Development and Validation of a Liquid Biopsy Assay with Cerebrospinal Fluid Derived Cell Free DNA using Droplet Digital PCR for Clinical Applications
6. O'Rourke D, et al. Comparing Comprehensive NGS Panel(s) Based Approach to Tissue Whole Exome Sequencing (WES) using Matched Tissue and Circulating Tumor DNA from Late Stage Colorectal Cancer Patients.
7. Smith N, et al. Longitudinal Evaluation of ctDNA Molecular Response for Monitoring Clinical Benefit and Investigating Treatment Related Impacts in Metastatic Colorectal Cancer Patients Treated with Different Drug Regimens
8. Wang D, et al. Characterization of Sideness related Differentiated Genetic Alterations in Stage I IV Colorectal Cancer Patients by using Whole Exome Sequencing
9. Wang D, et al. Comprehensive Next Generation Sequencing Profiling in Combination with Transcriptomic based Tumor Molecular Subtyping and Harmonized TMB Calculation using Paired Specimens from Late Stage CRC Patients

POSTERS

2022 Multidisciplinary Head and Neck Cancers Symposium (ASTRO MDT)

Other

1. Schoenfeld JD, et al. TrilynX: A phase 3 trial of xevinapant + concurrent chemoradiotherapy (CRT) for locally advanced head and neck cancer

POSTERS

American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, 2022

Avelumab

1. Powles T, et al. Avelumab first-line maintenance for advanced urothelial carcinoma: long-term follow-up results from the JAVELIN Bladder 100 trial
2. Eto M, et al. Avelumab first-line maintenance + best supportive care (BSC) vs BSC alone in Asian patients with advanced urothelial carcinoma: JAVELIN Bladder 100 subgroup analysis
3. Milloy N, et al. Criteria used to determine platinum eligibility and first-line (1L) treatment patterns among platinum-eligible (PE) and -ineligible (PI) patients with metastatic urothelial cancer (mUC) in France, Germany, Spain, Italy, and the UK (Eu5)
4. Gupta S, et al. Disease management and frontline treatment of locally advanced or metastatic urothelial (la/mUC) carcinoma: the US physician PARADIGM study
5. Grivas P, et al. PATRIOT II: an ambispective, observational, multicenter, 2-cohort study of avelumab first-line maintenance in locally advanced/metastatic urothelial carcinoma in the US
6. Nathan P, et al. Avelumab plus axitinib in advanced renal cell carcinoma (aRCC): 12-month interim results from a real-world observational study in the UK

Other

1. Turpin K, et al. Impact of COVID-19 on Cancer Caregivers: Results from the Global Carer Well-being Index

POSTERS

European Society for Medical Oncology (ESMO) 2021.

Avelumab

1. Ajmera M, et al. Real-world study assessing physician rationale for initiating first-line immuno-oncology therapy for patients with advanced urothelial cancer
2. Jensen J, et al. Treatment pattern and overall survival among patients with locally advanced or metastatic urothelial carcinoma – Results from a complete nationwide unselected real-world registry study in Denmark from 2010 to 2017
3. Bilen MA, et al. Real-world treatment patterns and clinical outcomes in patients with metastatic urothelial carcinoma (mUC) receiving first line (1L) treatment: results from IMPACT UC
4. Grimm M-O, et al. Role of prior nephrectomy for synchronous metastatic renal cell carcinoma (mRCC) on efficacy in patients treated with avelumab + axitinib or sunitinib: results from JAVELIN Renal 101

Tepotinib

1. Garassino M, et al. Efficacy and safety of tepotinib in patients with advanced age: VISION subgroup analysis of patients with MET exon 14 skipping NSCLC
2. Reinmuth N, et al. Health utility with tepotinib in patients with MET exon 14 (METex14) skipping non-small cell lung cancer (NSCLC)
3. Wu Y, et al. Tepotinib + osimertinib for EGFR-mutant NSCLC with resistance to first-line osimertinib due to MET amplification: INSIGHT 2
4. Marbury T, et al. Effect of hepatic Impairment on tepotinib pharmacokinetics

Bintrafusp alfa

1. Gulley J, et al. Adverse event management during treatment with bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1: treatment guidance based on experience in clinical trials

Berzosertib

1. Thomas A, et al. Phase 2 study of berzosertib (M6620) + topotecan in patients with relapsed platinum-resistant SCLC: DDRiver SCLC 250

ORAL PRESENTATIONS

European Society for Medical Oncology (ESMO) 2021

Bintrafusp alfa

1. Gulley J, et al. Long-term follow-up of patients with human papillomavirus (HPV)–associated malignancies treated with bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1

POSTERS

International Association for the Study of Lung Cancer (IASLC) 2021 World Conference on Lung Cancer (WCLC).

Tepotinib

1. Felip E, et al. Tepotinib in patients with MET exon 14 skipping NSCLC as identified by liquid or tissue biopsy
2. Liam CK, et al. Tepotinib plus an EGFR TKI in patients with EGFR-mutant NSCLC and resistance to EGFR TKIs due to MET amplification
3. Dooms C, et al. Tepotinib + osimertinib for EGFR-mutant NSCLC with resistance to first-line osimertinib due to MET amplification: INSIGHT 2

POSTERS

American Society of Clinical Oncology 2021, June 4-8, 2021 / Virtual.

1. Avelumab first-line (1L) maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma (UC): analysis of time to end of next-line therapy in JAVELIN Bladder 100
2. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC): analysis of clinical and genomic subgroups from the JAVELIN Bladder 100 trial
3. Avelumab first-line (1L) maintenance for advanced urothelial carcinoma (UC) in the JAVELIN Bladder 100 trial: subgroup analysis by duration of treatment-free interval (TFI) from end of chemotherapy to start of maintenance
4. Efficacy of avelumab + axitinib (A + Ax) vs sunitinib (S) by IMDC risk group in advanced renal cell carcinoma (aRCC): extended follow-up results from JAVELIN Renal 101
5. Outcomes of patients who progressed on avelumab + axitinib (A + Ax) and received subsequent treatments (Txs) in JAVELIN Renal 101
6. Association between neutrophil-to-eosinophil ratio (NER) and efficacy outcomes in the JAVELIN Renal 101 study
7. Association of C-reactive protein (CRP) with efficacy of avelumab + axitinib (A + Ax) in advanced renal cell carcinoma (aRCC): long-term follow-up results from JAVELIN Renal 101
8. Integrating peripheral biomarker analyses from JAVELIN Renal 101: avelumab + axitinib (A + Ax) vs sunitinib (S) in advanced renal cell carcinoma (aRCC)
9. Avelumab in patients with previously treated Merkel cell carcinoma (JAVELIN Merkel 200): updated overall survival data after >5 years of follow-up
10. Long-term follow-up of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck (SCCHN)
11. Tepotinib in patients (pts) with advanced non-small cell lung cancer (NSCLC) with MET amplification (METamp)
12. Phase II two-arm study of tepotinib + osimertinib in patients with EGFR-mutant NSCLC and acquired resistance to first-line osimertinib due to MET amplification: INSIGHT 2
13. PERSPECTIVE: Tepotinib + cetuximab in patients (pts) with RAS/BRAF wild-type left-sided metastatic colorectal cancer (mCRC) and acquired resistance to anti-EGFR antibody therapy due to MET amplification (METamp)
14. A First-in-Human Phase I Study of ATR Inhibitor M1774 in Patients with Solid Tumors

ORAL PRESENTATIONS

American Society of Clinical Oncology 2021, June 4-8, 2021 / Virtual.

1. Evaluation of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in cervical cancer: data from phase 1 and phase 2 studies

ORAL PRESENTATIONS

American Society of Clinical Oncology 2020
2021 Genitourinary Cancers Symposium, February 11-13, 2021 / Virtual.

1. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 subgroup analysis based on duration and cycles of first-line chemotherapy
2. Efficacy and safety of avelumab + axitinib vs sunitinib in elderly patients with advanced renal cell carcinoma: extended follow-up results from JAVELIN Renal 101
3. Efficacy of avelumab + axitinib vs sunitinib by number of IMDC risk factors and tumor sites at baseline in advanced renal cell carcinoma: extended follow-up results from JAVELIN Renal 101
4. Avelumab first-line maintenance plus best supportive care (BSC) vs BSC alone for advanced urothelial carcinoma: JAVELIN Bladder 100 Japanese subgroup analysis

POSTERS

Society for Immunotherapy of Cancer (SITC) Annual Meeting 2022 - November 8-12, 2022 / Boston, MA

Avelumab

1. Conway J, et al. Artificial Intelligence–Powered Immune Phenotyping of Advanced or Metastatic Urothelial Carcinoma Clinical Trial Samples from Hematoxylin and Eosin–Stained Whole Slide Images
2. D’Angelo SP, et al. First-Line Avelumab Treatment in Patients with Metastatic Merkel Cell Carcinoma: 4-Year Follow-Up from Part B of the JAVELIN Merkel 200 Trial
3. Hoffman-Censits J, et al. JAVELIN Bladder Medley: A Phase 2 Trial of Avelumab in Combination with Other Antitumor Drugs as First-Line Maintenance Therapy for Advanced Urothelial Carcinoma
4. Titov A, et al. Evaluation of Novel Anti-TIGIT Antibody M6223 as a Single Agent and in Combination with Avelumab on Human Natural Killer Cell Cytotoxicity

POSTERS

European Society for Medical Oncology 2022

Avelumab

1. Aragon-Ching JB, et al. Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results from Patients with ≥12 Months of Treatment in JAVELIN Bladder 100
2. Wilke T, et al. Undertreatment Rates, Associated Factors, and Survival Among Patients with Locally Advanced or Metastatic Urothelial Cancer (la/mUC): A Systematic Literature Review
3. Knott C, et al. Factors Associated with Receipt of Systemic Treatment for Metastatic Urothelial Carcinoma (mUC) in England
4. Lapuente M, et al, Evaluating Real-world Caregiver Involvement from a Survey of Patients with Metastatic Urothelial Cancer (mUC) Receiving Systemic Anticancer Treatment In France, Germany, Italy, Spain, and the UK (Eu5)
5. Barthélémy P, et al. Preliminary Results from AVENANCE, an Ongoing, Noninterventional Real-world, Ambispective Study of Avelumab First-line Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Carcinoma
6. Maráz A, et al. Real-world Treatment Patterns and Clinical Outcomes in Patients with Metastatic Urothelial Carcinoma (mUC): Results of a Nationwide, Longitudinal, Retrospective Study in Hungary
7. Ciardiello F, et al. Clinical Potential of Circulating Tumor DNA (ctDNA)–Based Molecular Response (MR) And Baseline Blood-based Tumor Mutational Burden (bTMB) for Monitoring Response to First-Line (1L) Chemoimmunotherapy in Advanced Squamous Non-small Cell Lung Cancer (sqNSCLC)

Tepotinib

1. Smit EF, et al. 985P – Tepotinib Outcomes According to Prior Therapies in Patients with MET Exon 14 (METex14) Skipping NSCLC
2. Ho C, et al. 1180P - Treatment Patterns and Progression-Free Survival In MET Exon 14 (METex14) Skipping Advanced Non-small Cell Lung Cancer (aNSCLC) In Real-World Clinical Practice)
3. Kelly RJ., et al. 1182P - US Real-World (RW) Patient Characteristics with METex14 Skipping Advanced Non-small Cell Lung Cancer (aNSCLC)

DDRi

1. Yoshida T, et al. Phase II Study of Berzosertib + Topotecan in Patients with Relapsed Platinum-Resistant SCLC (DDRiver SCLC 250): Japanese Safety Run-In

M6223

1. Siu L., et al. Phase I Study of TIGIT Inhibitor M6223 ± Bintrafusp Alfa in Patients with Metastatic/locally Advanced Unresectable Solid Tumours

ORAL PRESENTATIONS

European Society for Medical Oncology 2022

Avelumab

1. Powles T, et al. Genomic Biomarkers in Peripheral Blood (PB) from Patients (pts) Enrolled in the JAVELIN Bladder 100 Trial of Avelumab First-Line (1L) Maintenance in Advanced Urothelial Carcinoma (aUC)

Tepotinib

1. Mazieres J, et al. Tepotinib + Osimertinib for EGFRm NSCLC with MET Amplification (METamp) After Progression on First-Line (1L) Osimertinib: Initial Results from the INSIGHT 2 Study

Xevinapant

1. Bourhis J, et al. 5-Year Overall Survival (OS) in Patients (pts) with Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA SCCHN) Treated with Xevinapant + Chemoradiotherapy (CRT) vs Placebo + CRT in a Randomized, Phase 2 Study

DDRi

1. Yap TA, et al. 457MO – A Phase I Study of ATR Inhibitor M1774 in Patients with Solid Tumours (DDRiver Solid Tumours 301): Part A1 Results

PUBLICATIONS

Berzosertib

Preclinical Studies

1. Baschnagel AM, et al. ATR Inhibitor M6620 (VX-970) Enhances the Effect of Radiation in Non-Small Cell Lung Cancer Brain Metastasis Patient-Derived Xenografts. Mol Cancer Ther. 2021 Nov;20(11):2129-2139.
2. Fokas E, et al. Targeting ATR In Vivo Using the Novel Inhibitor VE-822 Results in Selective Sensitization of Pancreatic Tumors to Radiation. Cell Death Dis 2012;3(12):e441.
3. Hall AB, et al. Potentiation of Tumor Responses to DNA Damaging Therapy by the Selective ATR Inhibitor VX-970. Oncotarget 2014;5:5674-5685.
4. Jossé R, et al. ATR inhibitors VE-821 and VX-970 Sensitize Cancer Cells to Topoisomerase I Inhibitors by Disabling DNA Replication Initiation and Fork Elongation Responses. Cancer Res. 2014 Dec 1;74(23):6968-79.
5. Tu X, et al. ATR Inhibition Is a Promising Radiosensitizing Strategy for Triple-Negative Breast Cancer. Mol Cancer Ther. 2018 Nov;17(11):2462-2472.

Clinical Trials

1. Konstantinopoulos PA, et al. Berzosertib plus Gemcitabine Versus Gemcitabine Alone in Platinum-Resistant High-Grade Serous Ovarian Cancer: A Multicentre, Open-Label, Randomised, Phase 2 Trial. Lancet Oncol. 2020 Jul;21(7):957-968.
2. Middleton MR, et al. Phase 1 Study of the ATR Inhibitor Berzosertib (Formerly M6620, VX-970) Combined with Gemcitabine ± Cisplatin in Patients with Advanced Solid Tumours. Br J Cancer. 2021 Aug;125(4):510-519.
3. Pal SK, et al. Effect of Cisplatin and Gemcitabine with or without Berzosertib in Patients with Advanced Urothelial Carcinoma: A Phase 2 Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1536-1543.
4. Shapiro GI, et al. Phase 1 Study of the ATR inhibitor Berzosertib in Combination with Cisplatin in Patients with Advanced Solid Tumours. Br J Cancer. 2021 Aug;125(4):520-527
5. Thomas A, et al. Phase I Study of ATR Inhibitor M6620 in Combination With Topotecan in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Jun 1;36(16):1594-1602.
6. Thomas A, et al. Therapeutic Targeting of ATR Yields Durable Regressions in Small Cell Lung Cancers with High Replication Stress. Cancer Cell. 2021 Apr 12;39(4):566-579.e7.
7. Yap TA, et al. Phase I Trial of First-in-Class ATR Inhibitor M6620 (VX-970) as Monotherapy or in Combination with Carboplatin in Patients with Advanced Solid Tumors. J Clin Oncol 2020;38:3195-3204.

PUBLICATIONS

M1774

1. Blackford AN, et al. ATM, ATR, and DNA-PK: The Trinity at the Heart of the DNA Damage Response. Mol Cell. 2017 Jun 15;66(6):801-817.

PUBLICATIONS

M4076

Preclinical Studies

1. Blackford AN, et al. ATM, ATR, and DNA-PK: The Trinity at the Heart of the DNA Damage Response. Mol Cell. 2017 Jun 15;66(6):801-817.
2. Goldstein M, et al. The DNA Damage Response: Implications for Tumor Responses to Radiation and Chemotherapy. Annu Rev Med. 2015;66:129-43.
3. Shiloh Y. ATM and Related Protein Kinases: Safeguarding Genome Integrity. Nat Rev Cancer. 2003 Mar;3(3):155-68.

PUBLICATIONS

Peposertib

1. Davis AJ, et al. DNA Double Strand Break Repair Via Non-Homologous End-Joining. Transl Cancer Res. 2013 Jun;2(3):130-143.
2. Davis AJ, et al. DNA-PK: A Dynamic Enzyme in a Versatile DSB Repair Pathway. DNA Repair (Amst). 2014 May;17:21-9.
3. Scully R, et al. DNA Double-Strand Break Repair-Pathway Choice in Somatic Mammalian Cells. Nat Rev Mol Cell Biol. 2019 Nov;20(11):698-714.
4. Zenke FT, et al. Pharmacologic Inhibitor of DNA-PK, M3814, Potentiates Radiotherapy and Regresses Human Tumors in Mouse Models. Mol Cancer Ther. 2020 May;19(5):1091-1101.

PUBLICATIONS

Avelumab

Preclinical Studies

1. Boyerinas B, et al. Antibody-Dependent Cellular Cytotoxicity Activity of a Novel Anti-PD-L1 Antibody Avelumab (MSB0010718C) on Human Tumor Cells. Cancer Immunol Res. 2015;3(10):1148-1157.
2. Grenga I, et al. A Fully Human IgG1 Anti-PD-L1 MAb in An In Vitro Assay Enhances Antigen-Specific T-Cell Responses. Clin Transl Immunology. 2016;5(5):e83.
3. Jin H, et al. Avelumab Internalization by Human Circulating Immune Cells is Mediated by Both Fc Gamma Receptor and PD-L1 Binding. Oncoimmunology. 2021;10(1):1958590.

Clinical Trials

Merkel cell carcinoma

1. Amiot M, et al. Successful Rechallenge with Avelumab in Merkel Cell Carcinoma. Eur J Cancer. 2021;153:96-97.
2. Ascierto PA, et al. Avelumab Expanded Access Program in Metastatic Merkel Cell Carcinoma: Efficacy and Safety Findings from Patients in Europe and the Middle East. Int J Cancer. 2021;149(11):1926-1934.
3. Bhanegaonkar A, et al. Real-World Clinical Outcomes in Patients with Locally Advanced or Metastatic Merkel Cell Carcinoma Treated in U.S. Oncology Clinical Practices: Results from SPEAR-Merkel. Oncologist. 2021;26(9):e1633-e1643.
4. Bhanegaonkar A, et al. Real-World Outcomes Among Us Veterans Health Administration Patients Newly Diagnosed with Metastatic Renal Cell Carcinoma and Treated with First-Line Monotherapy. Adv Ther. 2021;38(5):2644-2661.
5. Bharmal M, et al. Health-Related Quality of Life Trajectory of Treatment-Naive Patients with Merkel Cell Carcinoma Receiving Avelumab. Future Oncol. 2020;16(27):2089-2099.
6. Bilic H, et al. Severe Demyelinating Polyneuropathy and Cranial Neuropathy During Avelumab Treatment of Metastatic Merkel Cell Carcinoma. Clin Neuropharmacol. 2021;44(5):193-195.
7. Buonerba L, et al. Hematological Toxicity During Concomitant Treatment with Ruxolitinib and Avelumab for Merkel Cell Carcinoma. Front Oncol. 2020;10:579914.
8. Cowey CL, et al. Real-World Clinical Outcomes with First-Line Avelumab in Locally Advanced/Metastatic Merkel Cell Carcinoma in the USA: SPEAR-Merkel. Future Oncol. 2021;17(18):2339-2350.
9. D'Angelo SP, et al. Efficacy and Safety of First-Line Avelumab Treatment in Patients with Stage IV Metastatic Merkel Cell Carcinoma: A Preplanned Interim Analysis of a Clinical Trial. JAMA Oncol. 2018;4(9):e180077.
10. D'Angelo SP, et al. Early Objective Response to Avelumab Treatment is Associated with Improved Overall Survival in Patients with Metastatic Merkel Cell Carcinoma. Cancer Immunol Immunother. 2019;68(4):609-618.
11. D'Angelo SP, et al. Avelumab in Patients with Previously Treated Metastatic Merkel Cell Carcinoma: Long-Term Data and Biomarker Analyses from the Single-Arm Phase 2 JAVELIN Merkel 200 trial. J Immunother Cancer. 2020;8(1):e000674.
12. D'Angelo SP, et al. Avelumab in Patients with Previously Treated Metastatic Merkel Cell Carcinoma (JAVELIN Merkel 200): Updated Overall Survival Data After >5 years of Follow-Up. ESMO Open. 2021;6(6):100290.
13. D'Angelo SP, et al. First-Line Avelumab in a Cohort of 116 Patients with Metastatic Merkel Cell Carcinoma (JAVELIN Merkel 200): Primary and Biomarker Analyses of a Phase II Study. J Immunother Cancer. 2021;9(7):e002646.
14. Fife K, et al. Case Report: Clinical Experience with Avelumab in Patients with Metastatic Merkel Cell Carcinoma and Brain Metastases Treated in Europe. Front Oncol. 2021;11:672021.
15. Garcia GA, et al. Avelumab as an Emerging Therapy for Eyelid and Periocular Merkel Cell Carcinoma. Int Ophthalmol Clin. 2020;60(2):91-102.
16. Kaufman HL, et al. Avelumab in Patients with Chemotherapy-Refractory Metastatic Merkel Cell Carcinoma: A Multicentre, Single-Group, Open-Label, Phase 2 Trial. Lancet Oncol. 2016;17(10):1374-1385.
17. Kaufman HL, et al. Updated Efficacy of Avelumab in Patients with Previously Treated Metastatic Merkel Cell Carcinoma After >/=1 Year of Follow-Up: JAVELIN Merkel 200, A Phase 2 Clinical Trial. J Immunother Cancer. 2018;6(1):7.
18. Kelly K, et al. Safety Profile of Avelumab in Patients with Advanced Solid Tumors: A Pooled Analysis of Data from the Phase 1 JAVELIN Solid Tumor and Phase 2 JAVELIN Merkel 200 Clinical Trials. Cancer. 2018;124(9):2010-2017.
19. Kelly K, et al. Efficacy and Immune-Related Adverse Event Associations in Avelumab-Treated Patients. J Immunother Cancer. 2020;8(2):e001427.
20. Lambert J, et al. Patient Experiences with Avelumab in Treatment-Naive Metastatic Merkel Cell Carcinoma: Longitudinal Qualitative Interview Findings from JAVELIN Merkel 200, a Registrational Clinical Trial. Patient. 2020;13(4):457-467.
21. Lanitis T, et al. Survival Analysis in Patients with Metastatic Merkel Cell Carcinoma Treated with Avelumab. Adv Ther. 2019;36(9):2327-2341.
22. Leao I, et al. Long-Term Response to Avelumab and Management of Oligoprogression in Merkel Cell Carcinoma: A Case Report. World J Clin Cases. 2021;9(18):4829-4836.
23. Levy S, et al. Avelumab for Advanced Merkel Cell Carcinoma in the Netherlands: A Real-World Cohort. J Immunother Cancer. 2020;8(2):e001076.
24. Mendoza P, et al. A Case Report of Leptomeningeal Carcinomatosis Secondary to Recurrent Merkel Cell Carcinoma After Avelumab. Perm J. 2021;25:20.235.
25. Walker JW, et al. Efficacy and Safety of Avelumab Treatment in Patients with Metastatic Merkel Cell Carcinoma: Experience from a Global Expanded Access Program. J Immunother Cancer. 2020;8(1):e000313.

Renal cell carcinoma

1. Bilen MA, et al. Association of Neutrophil-to-Lymphocyte Ratio with Efficacy of First-Line Avelumab plus Axitinib vs Sunitinib in Patients with Advanced Renal Cell Carcinoma Enrolled in the Phase 3 JAVELIN Renal 101 trial. Clin Cancer Res. 2021:Epub Nov 19.
2. Choueiri TK, et al. Preliminary Results for Avelumab Plus Axitinib as First-Line Therapy in Patients with Advanced Clear-Cell Renal-Cell Carcinoma (JAVELIN Renal 100): An Open-Label, Dose-Finding and Dose-Expansion, Phase 1b Trial. Lancet Oncol. 2018;19(4):451-460.
3. Choueiri TK, et al. Updated Efficacy Results from the JAVELIN Renal 101 Trial: First-Line Avelumab Plus Axitinib Versus Sunitinib in Patients with Advanced Renal Cell Carcinoma. Ann Oncol. 2020;31(8):1030-1039.
4. Choueiri TK, et al. Efficacy and Correlative Analyses of Avelumab Plus Axitinib Versus Sunitinib In Sarcomatoid Renal Cell Carcinoma: Post Hoc Analysis of a Randomized Clinical Trial. ESMO Open. 2021;6(3):100101.
5. Leslie I, et al. Avelumab and Axitinib in the Treatment of Renal Cell Carcinoma: Safety and Efficacy. Expert Rev Anticancer Ther. 2020;20(5):343-354.
6. Lu P, et al. A Cost-Effectiveness Analysis: First-Line Avelumab plus Axitinib Versus Sunitinib for Advanced Renal-Cell carcinoma. Front Pharmacol. 2020;11:619.
7. Motzer RJ, et al. Avelumab Plus Axitinib Versus Sunitinib for Advanced Renal-Cell Carcinoma. N Engl J Med. 2019;380(12):1103-1115.
8. Motzer RJ, et al. Avelumab Plus Axitinib Versus Sunitinib in Advanced Renal Cell Carcinoma: Biomarker Analysis of the Phase 3 JAVELIN Renal 101 Trial. Nat Med. 2020;26(11):1733-1741.
9. Shimizu N, et al. Avelumab Plus Axitinib Therapy for Renal Cell Carcinoma in a Patient with Pulmonary Alveolar Proteinosis: A Case Report. Urol Case Rep. 2021;39:101843.
10. Suzuki I, et al. A Case of Clear Cell Renal Cell Carcinoma with Vena Cava Thrombus Responding to Presurgical Avelumab, and Axitinib. IJU Case Rep. 2021;4(6):412-416.
11. Vaishampayan U, et al. Avelumab Monotherapy as First-Line or Second-Line Treatment in Patients with Metastatic Renal Cell Carcinoma: Phase Ib Results from the JAVELIN Solid Tumor Trial. J Immunother Cancer. 2019;7(1):275.
12. Zhang Y, et al. Avelumab Plus Axitinib vs. Sunitinib for Advanced Renal-Cell Carcinoma. Transl Cancer Res. 2019;8(Suppl 6):S585-S588.

Urothelial carcinoma

1. Apolo AB, et al. Avelumab, an Anti-Programmed death-ligand 1 Antibody, in Patients with Refractory Metastatic Urothelial Carcinoma: Results from a Multicenter, Phase Ib Study. J Clin Oncol. 2017;35(19):2117-2124.
2. Apolo AB, et al. Avelumab as Second-Line Therapy for Metastatic, Platinum-Treated Urothelial Carcinoma in the Phase Ib JAVELIN Solid Tumor Study: 2-Year Updated Efficacy and Safety Analysis. J Immunother Cancer. 2020;8(2):e001246.
3. Erck A, et al. Maintenance Avelumab for Metastatic Urothelial Cancer: A New Standard of Care. Cancer Biol Ther. 2020;21(12):1095-1096.
4. Grivas P, et al. Avelumab First-Line Maintenance in Locally Advanced or Metastatic Urothelial Carcinoma: Applying Clinical Trial Findings to Clinical Practice. Cancer Treat Rev. 2021;97:102187.
5. Gross-Goupil M, et al. Open-Label Randomized Multi-Center Phase 2 Study: Gemcitabine Cisplatin Plus Avelumab or Gemcitabine Cisplatin as First-Line Treatment of Patients with Locally Advanced or Metastatic Urothelial Bladder Carcinoma: GCisAve. Bull Cancer. 2020;107(5S):eS1-eS7.
6. Joshi M, et al. Avelumab in Combination with Eribulin Mesylate in Metastatic Urothelial Carcinoma: BTCRC GU-051, a Phase 1b Study. Eur Urol Focus. 2021.
7. Martinez Chanza N, et al. Avelumab As Neoadjuvant Therapy in Patients with Urothelial Non-Metastatic Muscle Invasive Bladder Cancer: A Multicenter, Randomized, Non-Comparative, Phase II Study (Oncodistinct 004 – AURA Trial). BMC Cancer. 2021;21(1):1292.
8. Novakovic AM, et al. Changing Body Weight-Based Dosing to a Flat Dose for Avelumab in Metastatic Merkel Cell and Advanced Urothelial Carcinoma. Clin Pharmacol Ther. 2020;107(3):588-596.
9. Patel MR, et al. Avelumab in Metastatic Urothelial Carcinoma after Platinum Failure (JAVELIN Solid Tumor): Pooled Results from Two Expansion Cohorts of An Open-Label, Phase 1 Trial. Lancet Oncol. 2018;19(1):51-64.
10. Peng Y, et al. Cost-Effectiveness of Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma in the United States. Adv Ther. 2021;38(12):5710-5720.
11. Powles T, et al. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. N Engl J Med. 2020;383(13):1218-1230.

Other tumors

1. Awada G, et al. Axitinib Plus Avelumab in the Treatment of Recurrent Glioblastoma: A Stratified, Open-Label, Single-Center Phase 2 Clinical Trial (GliAvAx). J Immunother Cancer. 2020;8(2):e001146.
2. Bang YJ, et al. Phase III, Randomised Trial of Avelumab Versus Physician's Choice of Chemotherapy as Third-Line Treatment of Patients with Advanced Gastric or Gastro-Oesophageal Junction Cancer: Primary Analysis of JAVELIN Gastric 300. Ann Oncol. 2018;29(10):2052-2060.
3. Barlesi F, et al. Avelumab Versus Docetaxel in Patients with Platinum-Treated Advanced Non-Small-Cell Lung Cancer (JAVELIN Lung 200): An Open-Label, Randomised, Phase 3 Study. Lancet Oncol. 2018;19(11):1468-1479.
4. Dirix LY, et al. Avelumab, an Anti-PD-L1 Antibody, in Patients with Locally Advanced or Metastatic Breast Cancer: A Phase 1b JAVELIN Solid Tumor Study. Breast Cancer Res Treat. 2018;167(3):671-686.
5. Elbers JBW, et al. Immuno-Radiotherapy with Cetuximab and Avelumab for Advanced Stage Head and Neck Squamous Cell Carcinoma: Results from a Phase-I Trial. Radiother Oncol. 2020;142:79-84.
6. Gassian N, et al. Activity and Tolerability of Maintenance Avelumab Immunotherapy after First Line Polychemotherapy Including Platinum in Patients with Locally Advanced or Metastatic Squamous Cell Penile Carcinoma: PULSE. Bull Cancer. 2020;107(5S):eS16-eS21.
7. Guigay J, et al. Avelumab for Platinum-Ineligible/Refractory Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck: Phase Ib Results from the JAVELIN Solid Tumor Trial. J Immunother Cancer. 2021;9(10):Epub Oct 20.
8. Hawkes EA, et al. Avelumab in Combination Regimens for Relapsed/Refractory DLBCL: Results from the Phase Ib JAVELIN DLBCL Study. Target Oncol. 2021;16(6):761-771.
9. Heery CR, et al. Avelumab for Metastatic or Locally Advanced Previously Treated Solid Tumours (JAVELIN Solid Tumor): A Phase 1a, Multicohort, Dose-Escalation Trial. Lancet Oncol. 2017;18(5):587-598.
10. Herrera AF, et al. Avelumab in Relapsed/Refractory Classical Hodgkin Lymphoma: Phase 1b Results from the JAVELIN Hodgkins Trial. Blood Adv. 2021;5(17):3387-3396.
11. Jacques FH, et al. Avelumab in Newly Diagnosed Dlioblastoma. Neurooncol Adv. 2021;3(1):vdab118.
12. Kazandjian D, et al. Avelumab, a PD-L1 Inhibitor, in Combination with Hypofractionated Radiotherapy and the Abscopal Effect in Relapsed Refractory Multiple Myeloma. Oncologist. 2021;26(4):288-e541.
13. Kim SJ, et al. Avelumab for the Treatment of Relapsed or Refractory Extranodal NK/T-cell Lymphoma: An Open-Label Phase 2 Study. Blood. 2020;136(24):2754-2763.
14. Kudo M, et al. Avelumab in Combination with Axitinib as First-Line Treatment in Patients with Advanced Hepatocellular Carcinoma: Results from the Phase 1b VEGF Liver 100 Trial. Liver Cancer. 2021;10(3):249-259.
15. Kwan EM, et al. Avelumab Combined with Stereotactic Ablative Body Radiotherapy in Metastatic Castration-Resistant Prostate Cancer: The Phase 2 ICE-PAC Clinical Trial. Eur Urol. 2021:Epub Sep 4.
16. Lee DW, et al. Phase II Study of Avelumab in Patients with Advanced Hepatocellular Carcinoma Previously Treated with Sorafenib. Clin Cancer Res. 2020.
17. Lee NY, et al. Avelumab Plus Standard-of-Care Chemoradiotherapy Versus Chemoradiotherapy Alone in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomised, Double-Blind, Placebo-Controlled, Multicentre, Phase 3 Trial. Lancet Oncol. 2021;22(4):450-462.
18. Lonardi S, et al. Randomized Phase II Trial of Avelumab Alone or in Combination with Cetuximab for Patients with Previously Treated, Locally Advanced, or Metastatic Squamous Cell Anal Carcinoma: The CARACAS study. J Immunother Cancer. 2021;9(11):e002996.
19. Martinelli E, et al. Cetuximab Rechallenge Plus Avelumab in Pretreated Patients with RAS Wild-Type Metastatic Colorectal Cancer: The Phase 2 Single-Arm Clinical CAVE Trial. JAMA Oncol. 2021;7(10):1529-1535.
20. Moehler M, et al. Phase III trial of Avelumab Maintenance After First-Line Induction Chemotherapy Versus Continuation of Chemotherapy in Patients with Gastric Cancers: Results from JAVELIN Gastric 100. J Clin Oncol. 2021;39(9):966-977.
21. Monk BJ, et al. Chemotherapy with or without Avelumab Followed by Avelumab Maintenance Versus Chemotherapy Alone in Patients with Previously Untreated Epithelial Ovarian Cancer (JAVELIN Ovarian 100): An Open-Label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(9):1275-1289.
22. Park K, et al. Impact of Subsequent Immune Checkpoint Inhibitor Treatment on Overall Survival with Avelumab vs Docetaxel in Platinum-Treated Advanced NSCLC: Post Hoc Analyses from the Phase 3 JAVELIN Lung 200 Trial. Lung Cancer. 2021;154:92-98.
23. Park K, et al. Avelumab Versus Docetaxel in Patients with Platinum-Treated Advanced NSCLC: 2-Year Follow-Up from the JAVELIN Lung 200 Phase 3 trial. J Thorac Oncol. 2021;16(8):1369-1378.
24. Pujade-Lauraine E, et al. Avelumab Alone or in Combination with Chemotherapy Versus Chemotherapy Alone in Platinum-Resistant or Platinum-Refractory Ovarian Cancer (JAVELIN Ovarian 200): An Open-Label, Three-Arm, Randomised, Phase 3 Study. Lancet Oncol. 2021;22(7):1034-1046.
25. Saxena K, et al. A Phase 1b/2 Study of Azacitidine with PD-L1 Antibody Avelumab in Relapsed/Refractory Acute Myeloid Leukemia. Cancer. 2021;127(20):3761-3771.
26. Shafique MR, et al. A Phase Ib/II Study of Pepinemab in Combination with Avelumab in Advanced Non-Small Cell Lung Cancer. Clin Cancer Res. 2021;27(13):3630-3640.
27. Shamseddine A, et al. Efficacy and Safety-In Analysis of Short-Course Radiation Followed by mFOLFOX-6 Plus Avelumab for Locally Advanced Rectal Adenocarcinoma. Radiat Oncol. 2020;15(1):233.
28. Taieb J, et al. Avelumab Versus Standard Second Line Treatment Chemotherapy in Metastatic Colorectal Cancer Patients with Microsatellite Instability: The SAMCO-PRODIGE 54 Randomised Phase II Trial. Dig Liver Dis. 2021;53(3):318-323.
29. Tao Y, et al. Avelumab-Cetuximab-Radiotherapy Versus Standards of Care in Locally Advanced Squamous-Cell Carcinoma of the Head and Neck: The Safety Phase of a Randomised Phase III Trial GORTEC 2017-01 (REACH). Eur J Cancer. 2020;141:21-29.
30. Verschraegen CF, et al. Efficacy and Safety of First-Line Avelumab in Patients with Advanced Non-Small Cell Lung Cancer: Results from a Phase Ib Cohort of the JAVELIN Solid Tumor Study. J Immunother Cancer. 2020;8(2):e001064.
31. Zheng H, et al. A Phase I Clinical Trial of Avelumab in Combination with Decitabine as First Line Treatment of Unfit Patients with Acute Myeloid Leukemia. Am J Hematol. 2021;96(2):E46-E50.

PUBLICATIONS

Bintrafusp alfa

Preclinical Studies

1. Knudson KM, et al. M7824, a Novel Bifunctional Anti-PD-L1/TGFβ Trap Fusion Protein, Promotes Anti-Tumor Efficacy as Monotherapy and in Combination with Vaccine. Oncoimmunology. 2018 Feb 14;7(5):e1426519. Erratum in: Oncoimmunology. 2019 Feb 27;8(5):e1584435.
2. Lan Y, et al. Enhanced Preclinical Antitumor Activity of M7824, a Bifunctional Fusion Protein Simultaneously Targeting PD-L1 and TGF-β. Sci Transl Med. 2018 Jan 17;10(424):eaan5488.
3. Lind H, et al. Dual Targeting of TGF-β and PD-L1 Via a Bifunctional Anti-PD-L1/TGF-βRII Agent: Status of Preclinical and Clinical Advances. J Immunother Cancer. 2020 Feb;8(1):e000433.
4. Morillon YMI, et al. The Use of a Humanized NSG-β2m-/- Model for Investigation of Immune and Anti-tumor Effects Mediated by the Bifunctional Immunotherapeutic Bintrafusp Alfa. Front Oncol. 2020 Apr 21;10:549. Erratum in: Front Oncol. 2020 Jul 24;10:1548.

Clinical Trials

1. Cho BC, et al. Bintrafusp alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Advanced Squamous Cell Carcinoma of the Head and Neck: Results from a Phase I Cohort. J Immunother Cancer. 2020 Jul;8(2):e000664. Erratum in: J Immunother Cancer. 2020 Oct;8(2).
2. Paz-Ares L, et al. Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients with NSCLC: Results from an Expansion Cohort of a Phase 1 Trial. J Thorac Oncol. 2020 Jul;15(7):1210-1222.
3. Strauss J, et al. Phase I Trial of M7824 (MSB0011359C), a Bifunctional Fusion Protein Targeting PD-L1 and TGFβ, in Advanced Solid Tumors. Clin Cancer Res. 2018 Mar 15;24(6):1287-1295.
4. Strauss J, et al. Bintrafusp alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Patients with Human Papillomavirus-Associated Malignancies. J Immunother Cancer. 2020 Dec;8(2):e001395.
5. Vugmeyster Y, et al. Selection of the Recommended Phase 2 Dose for Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1. Clin Pharmacol Ther. 2020 Sep;108(3):566-574.
6. Wilkins JJ, et al. Population Pharmacokinetic Analysis of Bintrafusp Alfa in Different Cancer Types. Adv Ther. 2019 Sep;36(9):2414-2433.

PUBLICATIONS

M6223

1. Fourcade J, et al. CD226 Opposes TIGIT to Disrupt Tregs in Melanoma. JCI Insight. 2018 Jul 26;3(14):e121157.
2. Harjunpää H, et al. TIGIT as an Emerging Immune Checkpoint. Clin Exp Immunol. 2020 May;200(2):108-119.
3. Johnston RJ, et al. The immunoreceptor TIGIT Regulates Antitumor and Antiviral CD8(+) T Cell Effector Function. Cancer Cell. 2014 Dec 8;26(6):923-937.
4. Joller N, et al. Treg Cells Expressing the Coinhibitory Molecule TIGIT Selectively Inhibit Proinflammatory Th1 and Th17 Cell Responses. Immunity. 2014 Apr 17;40(4):569-81.
5. Kurtulus S, et al. TIGIT Predominantly Regulates the Immune Response Via Regulatory T Cells. J Clin Invest. 2015 Nov 2;125(11):4053-62.

PUBLICATIONS

M1231

1. Nath S, et al. MUC1: A multifaceted Oncoprotein with a Key Role in Cancer Progression. Trends Mol Med. 2014 Jun;20(6):332-42.

PUBLICATIONS

Tepotinib

Preclinical Studies

1. Bladt F, et al. EMD 1214063 and EMD 1204831 Constitute a New Class of Potent and Highly Selective c-Met Inhibitors. Clin Cancer Res. 2013 19:2941-51
2. Bladt F, et al. The c-Met Inhibitor MSC2156119J Effectively Inhibits Tumor Growth in Liver Cancer Models. Cancers 2014 6:1736-52
3. Friese-Hamim M, et al. The Selective c-Met Inhibitor Tepotinib Can Overcome Epidermal Growth Factor Receptor Inhibitor Resistance Mediated by Aberrant c-Met Activation in NSCLC Models. Am J Cancer Res. 2017 Apr 1;7(4):962-972.

Clinical Trials

Non-small cell lung cancer

1. Le X, et al. Tepotinib Efficacy and Safety in Patients with MET Exon 14 Skipping NSCLC: Outcomes in Patient Subgroups from the VISION Study with Relevance for Clinical Practice. Clin Cancer Res. 2021 Nov 17.
2. Paik PK, et al. Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations. N Engl J Med. 2020 Sep 3;383(10):931-943.
3. Wu YL, et al. Tepotinib Plus Gefitinib in Patients with MET Overexpression and/or MET Amplification, EGFR-Mutant NSCLC Having Acquired Resistance to Prior EGFR Inhibitor. Lancet Respir Med. 2020 May 29;S2213-2600(20)30154-5
4. Wu YL, et al. Tepotinib Plus Gefitinib in Patients with EGFR-Mutant Non-Small-Cell Lung Cancer with MET Overexpression or MET Amplification and Acquired Resistance to Previous EGFR Inhibitor (INSIGHT study): An Open-Label, Phase 1b/2, Multicentre, Randomised Trial. Lancet Respir Med. 2020 Nov;8(11):1132-1143.

Other tumors

1. Decaens T, et al. Phase 1b/2 Trial of Tepotinib in Sorafenib Pretreated Advanced Hepatocellular Carcinoma with MET Overexpression. British Journal of Cancer. 2021 Apr 6:1-0.
2. Falchook GS, et al. First-in-Man Phase I Trial of the Selective MET Inhibitor Tepotinib in Patients with Advanced Solid Tumors. Clin Cancer Res. 2020 Mar 15;26(6):1237-1246.
3. Johne A, et al. Open-Label, Single-Center, Phase I Trial to Investigate the Mass Balance and Absolute Bioavailability of the Highly Selective Oral MET Inhibitor Tepotinib in Healthy Volunteers. Invest New Drugs. 2020 Oct;38(5):1507-1519.
4. Ryoo BY, et al. Randomised Phase 1b/2 Trial of Tepotinib vs Sorafenib in Asian Patients with Advanced Hepatocellular Carcinoma with MET Overexpression. British Journal of Cancer. 2021 May 10:1-9.

PUBLICATIONS

Xevinapant

Preclinical Studies

1. Bobardt M, et al. The Inhibitor of Apoptosis Proteins Antagonist Debio 1143 Promotes the PD-1 Blockade-Mediated HIV Load Reduction in Blood and Tissues of Humanized Mice. PLoS One. 2020 Jan 24;15(1):e0227715.
2. Langdon CG, et al. SMAC Mimetic Debio 1143 Synergizes with Taxanes, Topoisomerase Inhibitors and Bromodomain Inhibitors to Impede Growth of Lung Adenocarcinoma Cells. Oncotarget. 2015 Nov 10;6(35):37410-25.
3. Liu N, et al. Debio 1143, an Antagonist of Multiple Inhibitor-of-Apoptosis Proteins, Activates Apoptosis and Enhances Radiosensitization of Non-Small Cell Lung Cancer Cells In Vitro. Am J Cancer Res. 2014 Nov 19;4(6):943-51.
4. Matzinger O, et al. The Radiosensitizing Activity of the SMAC-Mimetic, Debio 1143, is TNFα-Mediated in Head and Neck Squamous Cell Carcinoma. Radiother Oncol. 2015 Sep;116(3):495-503.
5. Tao Z, McCall NS, et al. SMAC Mimetic Debio 1143 and Ablative Radiation Therapy Synergize to Enhance Antitumor Immunity Against Lung Cancer. Clin Cancer Res. 2019 Feb 1;25(3):1113-1124.
6. Thibault B, et al. DEBIO 1143, an IAP Inhibitor, Reverses Carboplatin Resistance in Ovarian Cancer Cells and Triggers Apoptotic or Necroptotic Cell Death. Sci Rep. 2018 Dec 14;8(1):17862.

Clinical Trials

1. Gomez-Roca C, et al. Exploratory Window-of-Opportunity Trial to Investigate the Tumor Pharmacokinetics/Pharmacodynamics of the IAP Antagonist Debio 1143 in Patients with Head and Neck Cancer. Clin Transl Sci. 2021 Mar 20.
2. Hurwitz HI, et al. Safety, Pharmacokinetics, and Pharmacodynamic Properties of Oral DEBIO1143 (AT-406) in Patients with Advanced Cancer: Results of a First-in-Man Study. Cancer Chemother Pharmacol. 2015 Apr;75(4):851-9.
3. Le Tourneau C, et al. Phase I Trial of Debio 1143, an Antagonist of Inhibitor of Apoptosis Proteins, Combined with Cisplatin Chemoradiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2020 Dec 15;26(24):6429-6436.
4. Shi Y, et al. Activity and Safety of Geptanolimab (GB226) for Patients with Unresectable, Recurrent, or Metastatic Alveolar Soft Part Sarcoma: A Phase II, Single-Arm Study. Clin Cancer Res. 2020 Dec 15;26(24):6445-6452.
5. Sun XS, et al. The IAP Antagonist Debio 1143 Enhances Chemoradiotherapy in HNSCC. Cancer Discov. 2020 Oct;10(10):1437.
6. Sun XS, et al. Debio 1143 and High-Dose Cisplatin Chemoradiotherapy in High-Risk Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck: A Double-Blind, Multicentre, Randomised, Phase 2 Study. Lancet Oncol. 2020 Sep;21(9):1173-1187.

Upcoming Programs

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