- Zenocutuzumab efficacy and safety in advanced NRG1+ cholangiocarcinoma: Analysis from the phase 2 eNRGy trial
Schram AM, Clearly JM, Arnold D, Hollebecque A, Gbolahan O, Nagasaka M, Siena S, Opdam F, Sunakawa Y, Cassier PA, Trikha G, Florou V, Greil R, La Porte PF, Gandhi P, Garner F, Wasserman E, Adeyemi S, Springfeld C. [abstract]. Mol Cancer Ther. 2025;Vol:Abstract#.
Poster presented at American Association for Cancer Research (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics 2025; October 23, 2025; Boston, MA.
Oral presentation at American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics 2025; October 25, 2025; Boston, MA.
- Efficacy of zenocutuzumab in NRG1 fusion–positive cancer
Schram AM, Goto K, Kim DW, Macarulla T, Hollebecque A, O’Reilly EM, Ou SI, Rodon J, Rha SY, Nishino K, Duruisseaux M, Park JO, Neuzillet C, Liu SV, Weinberg BA, Cleary JM, Calvo E, Umemoto K, Nagasaka M, Springfeld C, Bekaii-Saab T, O’Kane GM, Opdam F, Reiss KA, Joe AK, Wasserman E, Stalbovskaya V, Ford J, Adeyemi S, Jain L, Jauhari S, Drilon A; eNRGy Investigators. N Engl J Med. 2025;392(6):566-576. doi: 10.1056/NEJMoa2405008. - Zenocutuzumab, a HER2 × HER3 bispecific antibody, is effective in cancer models with high NRG1 expression
O’Connor MN, Schackmann RCJ, Odintsov I, Fatrai S, Brinkman AB, Walker S, Lammerts van Bueren JJ, Geuijen CAW. Poster presented at American Association for Cancer Research (AACR) Annual Meeting 2024; April 8, 2024; San Diego, CA. - The phase I/II eNRGy trial: Zenocutuzumab in patients with cancers harboring NRG1 gene fusions
Kim DW, Schram AM, Hollebecque A, Nishino K, Macarulla T, Rha SY, Duruisseaux M, Liu SV, Al Hallak MN, Umemoto K, Wesseler C, Cleary JM, Springfeld C, Neuzillet C, Joe A, Jauhari S, Ford J, Goto K. Future Oncol. 2024;20(16):1057-1067. doi:10.2217/fon-2023-0824 - Durable efficacy of zenocutuzumab, a HER2 × HER3 bispecific antibody, in advanced NRG1fusion–positive (NRG1+) non-small cell lung cancer (NSCLC)
Schram AM, Goto K, Kim DW, Hollebecque A, Rha SY, Nishino K, Duruisseaux M, Umemoto K, Park JO, Leighl N, Macarulla T, Liu SV, Al Hallak MN, Cleary J, Neuzillet C, Goto Y, Joe AK, Adeyemi S, Jauhari S, Drilon AE. Poster presented at European Society for Medical Oncology (ESMO) Asia Congress; December 2, 2023; Singapore. - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) non-small cell lung cancer (NSCLC)
Schram AM, Goto K, Kim DW, Hollebecque A, Rha SY, Nishino K, Duruisseaux M, Umemoto K, Park JO, Leighl N, Macarulla T, Liu SV, Al Hallak MN, Cleary J, Neuzillet C, Goto Y, Joe AK, Adeyemi S, Jauhari S, Drilon AE. Oral presentation presented at European Society for Medical Oncology (ESMO) Congress; October 21, 2023; Madrid, Spain. - Durable efficacy of zenocutuzumab, a HER2 × HER3 bispecific antibody, in advanced NRG1 fusion–positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)
Schram AM, Macarulla T, Cleary JM, Neuzillet C, Arnold D, Reiss KA, Bekaii-Saab T, Rodon J, Goto K, Rha SY, Duruisseaux M, Leighl N, Weinberg BA, Al Hallak MN, Joe AK, Adeyemi S, Wasserman E, Koeman KJ, Drilon AE, O’Reilly EM. Poster presented at European Society for Medical Oncology (ESMO) Congress 2023; October 20, 2023; Madrid, Spain. - Sustained tumor regression with zenocutuzumab, a bispecific antibody targeting human epidermal growth factor receptor 2/human epidermal growth factor receptor 3 signaling, in NRG1 fusion-positive, estrogen receptor-positive breast cancer after progression on a cyclin-dependent kinase 4/6 inhibitor
Fontana E, Torga G, Fostea R, Cleator S, Wasserman E, Murat A, Arkenau HT. JCO Precis Oncol. 2022;6:e2100446. doi:10.1200/PO.21.00446 - Efficacy and safety of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion-positive (NRG1+) cancer
Schram AM, Goto K, Kim DW, Martin-Romano P, Ou SH I, O’Kane GM, O’Reilly EM, Umemoto K, Duruisseaux M, Neuzillet C, Opdam F, Ahnert JR, Nagasaka M, Weinberg BA, Macarulla T, Joe AK, Ford J, Stalbovskaya V, Wasserman E, Drilon AE. Oral presentation presented at American Society of Clinical Oncology (ASCO) Annual Meeting; June 5, 2022; Chicago IL. - Zenocutuzumab, a HER2xHER3 bispecific antibody, is effective therapy for tumors driven by NRG1 gene rearrangements
Schram AM, Odintsov I, Espinosa-Cotton M, Khodos I, Sisso WJ, Mattar MS, Lui AJW, Vojnic M, Shameem SH, Chauhan T, Torrisi J, Ford J, O’Connor MN, Geuijen CAW, Schackmann RCJ, Lammerts van Bueren JJ, Wasserman E, de Stanchina E, O’Reilly EM, Ladanyi M, Drilon A, Somwar R. Cancer Discov. 2022;12(5):1233-1247. doi:10.1158/2159-8290.CD-21-1119 - Updated analysis of MCLA-128 (zenocutuzumab), trastuzumab, and vinorelbine in patients with HER2 positive/amplified (HER2+) metastatic breast cancer who progressed on previous anti-HER2 ADCs
Hamilton EP, Petit T, , Pistilli B, Goncalves A, Ferreira AA, Dalenc F, Cardoso F, Mita MM, Manso L, Karim SM, Bidard FC, Aftimos PG, Escrivá-de-Romani S, Afonso N, Wasserman E, Bol K, Stalbovskaya V, Vliet A, Murat A, Bekradda M, Bachelot T. Poster presented at San Antonio Breast Cancer Symposium (SABCS); December 10, 2021; San Antonio, TX. - Zenocutuzumab is an effective HER2/HER3 Biclonics® antibody in cancers with NRG1 fusions
Gerlach J, Odintsov I, Deshiere A, Schackmann R, Ladanyi M, Lammerts van Bueren J, Somwar R, Geuijen C. Oral presentation presented at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics; October 7, 2021; Virtual meeting. - Efficacy and safety of zenocutuzumab in advanced pancreatic cancer and other solid tumors harboring NRG1 fusions
Schram AM, O’Reilly EM, O’Kane GM, Goto K, Kim DW, Neuzillet C, Martin-Romano P, Duruisseaux M, Nagasaka M, Rodon J, Weinberg BA, Umemoto K, Ou SH I, Macarulla T, de la Fouchardiere C, Joe AK, Wasserman E, Stalbovskaya V, Ford J, Drilon AE. Oral presentation presented at American Society of Clinical Oncology (ASCO) Annual Meeting; June 4, 2021; Virtual meeting. - The HER2×HER3 bi-specific antibody zenocutuzumab is effective at blocking growth of tumors driven by NRG1 gene fusions
Odintsov I, Khodos I, Espinosa-Cotton M, Lui AJW, Mattar M, Schram AM, O’Connor MN, Geuijen CAW, Schackmann RCJ, Lammerts van Bueren JJ, De Stanchina E, Ladanyi M, and Somwara R. Poster presented at American Association for Cancer Research (AACR) Annual Meeting; April 10, 2021; Virtual meeting. - Zenocutuzumab, an antibody that can overcome HER3 mediated NRG1 signaling in tumor cells by docking on HER2
Gerlach JP, De Nardis C, Maussang D, Rovers E, Gallenne T, Hendriks LJA, Visser T, Nijhuis R, Kramer A, Gros P, Logtenberg T, de Kruif J, Throsby M, Lundberg AS, Geuijen CAW. Poster presented at American Association for Cancer Research (AACR) Annual Meeting; April 10, 2021; Virtual meeting. - Phase 2 study of zenocutuzumab (MCLA-128), a bispecific HER2/HER3 antibody in NRG1 fusion-positive advanced solid tumors
Schram AM, Macarulla Mercade T, O’Reilly EM, Rodon J, Wolpin BM, Ou S-HI, Kim D-W, Yang JCH, Lam JYC, de Langen AJ, Boni V, Cerea G, Duruisseaux M, Felip E, Liu SV, O’Kane GM, Senecal F, Nagasaka M, Starr J, Wasserman E, Drilon AE. Presented at International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer; January 28, 2021; Singapore. - NRG1 fusion-driven cancers: A systematic literature review and meta-analysis
Stalbovskaya V, Wasserman E, Fryzek J, Bylsma LC, Sirulnik LA. Presented at American Society of Clinical Oncology (ASCO) Annual Meeting; May 29, 2020; Virtual meeting. Abstract published in J Clin Oncol. 2020;38(15_suppl):e15605. doi:10.1200/JCO.2020.38.15_suppl.e15 - A phase 2 basket study of MCLA-128, a bispecific antibody targeting the HER3 pathway, in NRG1 fusion-positive advanced solid tumors
Schram AM, Drilon AE, Macarulla Mercade T, O’Reilly EM, Rodon J, Wolpin BM, Ou S-HI, Kim D-W, Yang JCH, Lam JYC, Varga A, de Langen AJ, Witteveen P, Boni V, Cerea G, Duruisseaux M, Liu SV, Wasserman E, Hyman DM, Tabernero J. Poster presented at American Society of Clinical Oncology (ASCO) Annual Meeting; May 29, 2020; Virtual meeting. - Clinical activity of MCLA-128 (zenocutuzumab) in combination with endocrine therapy (ET) in ER+/HER2-low, non-amplified metastatic breast cancer patients with ET-resistant disease who had progressed on a cyclin-dependent kinase (CDK) 4/6 inhibitor
Pistilli B, Wildiers H, Hamilton EP, Ferreira AA, Dalenc F, Vidal M, Gavila J, Goncalves A, Murias C, Mouret-Reynier MA, Canon JL, Bazan F, Ladoire S, Sirulnik LA, Bekradda M, Bol K, Stalbovskaya V, Murat A, Ford J, Bidard FC. Poster presented at American Society of Clinical Oncology (ASCO) Annual Meeting; May 29, 2020; Virtual meeting. - Clinical activity of MCLA-128 (zenocutuzumab), trastuzumab and vinorelbine in HER2-amplified metastatic breast cancer patients (MBC) who had progressed on anti-HER2 antibody drug conjugates (ADCs)
Hamilton EP, Petit T, Pistilli B, Goncalves A, Ferreira AA, Dalenc F, Cardoso F, Mita MM, Dezentjé VO, Manso L, Graff SL, Bidard FC, Aftimos PG, Escrivá-de-Romani S, Afonso N, Wasserman E, Bol K, Stalbovskaya V, Vliet A, Bachelot T. Poster presented at American Society of Clinical Oncology (ASCO) Meeting; May 29, 2020; Virtual meeting. - Population pharmacokinetics of MCLA-128, a HER2/HER3 bispecific monoclonal antibody, in patients with solid tumors
de Vries Schultink AHM, Bol K, Doornbos RP, Murat A, Wasserman E, Dorlo TPC, Schellens JHM, Beijnen JH, Huitema ADR. Clin Pharmacokinet. 2020;59(7):875-884. doi:10.1007/s40262-020-00858-2 - Clinical proof-of-concept for MCLA-128, a bispecific HER2/3 antibody therapy, in NRG1 fusion-positive cancers
Schram AM, O’Reilly EM, Somwar R, Benayed R, Shameem S, Chauhan T, Torrisi J, Ford J, Maussang D, Wasserman E, Ladanyi M, Hyman DM, Sirulnik LA, Drilon AE.Oral presentation presented at AACR-NCI-EORTC Congress; October 27, 2019; Boston, MA. - Clinical proof-of-concept for MCLA-128, a bispecific HER2/3 antibody therapy, in NRG1 fusion-positive cancers
Schram AM, O’Reilly EM, Somwar R, Benayed R, Shameem S, Chauhan T, Torrisi J, Ford J, Maussang D, Wasserman E, Ladanyi M, Hyman DM, Sirulnik LA, Drilon AE. Poster presented at AACR-NCI-EORTC Congress; October 27, 2019; Boston, MA. - A phase 2 basket study of MCLA-128, a bispecific antibody targeting the HER3 pathway, in NRG1 fusion-positive advanced solid tumors
Schram AM, Drilon A, Macarulla Mercade T, O’Reilly EM, Rodon J, Wolpin B, Ou S-HI, Kim D-W, Yang JCH, Lam YC, Varga A, de Langen AJ, Witteveen P, Boni V, Cerea G, Duruisseaux M, Liu SV, Wasserman E, Hyman DM, Tabernero J. Poster presented at European Society for Medical Oncology (ESMO) Congress; September 29, 2019; Barcelona, Spain. - Phase 1/2 study of single agent MCLA-128, a full length IgG1 bispecific antibody targeting the HER3 pathway: overall safety at recommended Phase 2 dose (R2PD) and preliminary activity in HER2+ metastatic gastric/gastroesophageal junction cancer (GC/GEJ)
Alsina M, Varga A, Amatu A, Schellens JHM, Witteveen E, Boni V, Moreno V, Nuciforo P, de Vries Schultink A, Bol K, Lourbakos A, Magin Ferrer M, Wasserman E. Poster presented at European Society for Medical Oncology (ESMO) Congress; October 21, 2018; Munich, Germany. - Unbiased combinatorial screening identifies a bispecific IgG1 that potently inhibits HER3 signaling via HER2-guided ligand blockade
Geuijen CAW, De Nardis C, Maussang D, Rovers E, Gallenne T, Hendriks LJA, Visser T, Nijhuis R, Logtenberg T, de Kruif J, Gros P, Throsby M. Cancer Cell. 2021;39(8):1163-1164. doi: 10.1016/j.ccell.2021.07.015 - Translational PK-PD modeling analysis of MCLA-128, a HER2/HER3 bispecific monoclonal antibody, to predict clinical efficacious exposure and dose
de Vries Schultink AHM, Doornbos RP, Bakker ABH, Bol K, Throsby M, Geuijen C, Maussang D, Schellens JHM, Beijnen JH, Huitema ADR. Invest New Drugs. 2018;36(6):1006-1015. doi:10.1007/s10637-018-0593-x - First-in-human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody targeting HER2 and HER3; final phase 1 data and preliminary activity in HER2+ metastatic breast cancer (MBC)
Alsina M, Boni V, de Vries Schultink A, Moreno V, Bol K, Westendorp M, Sirulnik LA, Tabernero J, Calvo E. Poster presented at American Society of Clinical Oncology (ASCO) Annual Meeting; June 2, 2017; Chicago, IL. - The binding mode of the bispecific anti-HER2xHER3 antibody MCLA-128 is responsible for its potent inhibition of HRG-driven tumorigenesis
Maussang D, De Nardis C, Hendriks L, Bartelink-Clements C, Nieuwenhuizen N, Rovers E, Gallenne T, Doornbos R, Bakker L, Logtenberg T, de Kruif J, Gros P, Geuijen C, Throsby M. Poster presented at American Association for Cancer Research (AACR) Annual Meeting; April 1, 2017; Washington, DC. - Mechanism of action of MCLA-128, a humanized bispecific IgG1 antibody targeting the HER2:HER3 heterodimer
Geuijen C, Rovers E, Gallenne T, Maussang-Detaille D, Kramer A, Nieuwenhuizen N, van Zoest K, Nijhuis R, Visser T, den Blanken-Smit R, Basmeleh A, Bartelink W, Zondag-van der Zande V, Clements C, Kaldenberg L, Fokko van Loo P, Roovers R, Price L, Braam S, Doornbos R, van Driel Shamsili S, Bakker L, Logtenberg T, de Kruif J, Throsby M. Poster presented at American Association for Cancer Research (AACR) Annual Meeting; April 22, 2015; Philadelphia, Pennsylvania.
Note: Not all clinical trials and publications are listed.