A Study of Tepotinib Plus Osimertinib in Osimertinib Relapsed MET Amplified NSCLC (INSIGHT 2)
A Phase II, Two-arm Study to Investigate Tepotinib Combined With Osimertinib in MET Amplified, Advanced or Metastatic NSCLC Harboring Activating EGFR Mutations and Having Acquired Resistance to Prior Osimertinib Therapy (INSIGHT 2)
3 other identifiers
interventional
140
17 countries
179
Brief Summary
This study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (PK) of the Mesenchymal-epithelial Transition Factor (MET) inhibitor tepotinib combined with the 3rd generation EGFR inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 nonsmall-cell-lung-cancer
Started Sep 2019
Longer than P75 for phase_2 nonsmall-cell-lung-cancer
179 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedStudy Start
First participant enrolled
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2023
CompletedResults Posted
Study results publicly available
June 4, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFebruary 27, 2026
February 1, 2026
3.6 years
May 6, 2019
May 6, 2024
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0)
DLTs are defined as any of the following toxicities and judged by the Investigator and/or the Sponsor to be not attributable to the disease or disease-related processes under investigation: Grade 4 neutropenia for more than 7 days; Grade greater than or equal to (\>=) 3 febrile neutropenia; Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with non-traumatic bleeding; Grade \>= 3 nausea/vomiting and/or diarrhea that has not improved within 72 hours despite adequate and optimal treatment; Any other Grade \>= 3 non-hematological AE, except alopecia or Grade 3 nauseas/vomiting and/or diarrhea that has improved within 72 hours with optimal treatment.
Up to Day 21 of Cycle 1 (each Cycle is of 21 days)
Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Fluorescence in Situ Hybridization(FISH)
Objective response was defined as percentage of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Secondary Outcomes (45)
Combined Therapy: Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by Blood-Based Next Generation Sequencing
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Monotherapy (Tepotinib): Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)Version1.1 as Per Independent Review Committee in Participants With MET Amplification Determined Centrally by FISH
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Number of Participants With Clinically Significant Abnormalities in Laboratory Values Reported as Treatment Related TEAEs
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
Number of Participants With Markedly Abnormal Vital Sign Measurements
Time from first administration of study treatment up to data cutoff (approximately assessed up to 42 months)
- +40 more secondary outcomes
Study Arms (2)
Tepotinib and Osimertinib
EXPERIMENTALParticipants received a single oral dose of Tepotinib 500 milligrams (mg) followed by Omisertinib 80 mg once daily until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.
Tepotinib Mono-therapy
EXPERIMENTALParticipants received a single oral dose of Tepotinib 500 mg until disease progression, death, adverse event leading to discontinuation, study withdrawal or consent withdrawal.
Interventions
Participants were administered with Tepotinib orally once daily at a dose of 500 mg.
Participants received Osimertinib at a dose of 80 mg orally once daily.
Eligibility Criteria
You may qualify if:
- Locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) histology (confirmed by either histology or cytology) with documented activating Epidermal Growth Factor Receptor (EGFR) mutation
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a minimum life expectancy of 12 weeks
- Acquired resistance on previous first-line osimertinib. Participants must meet both of the following 2 criteria:
- Radiological documentation of disease progression on first-line osimertinib
- Objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (SD) (SD should last greater than (\>) 6 months after initiation of osimertinib
- Have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic NSCLC setting
- MET amplification as determined by either FISH testing (central or local) on tumor tissue (TBx) or central blood-based next generation sequencing (LBx). Tumor and blood samples must be collected following progression on prior first-line osimertinib at Prescreening
- Submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for MET amplification testing
- Submission of tumor tissue during Prescreening or Screening is mandatory for patients with tumor tissue tested by local FISH, to confirm MET amplification status. Central confirmation is not mandated prior to the start of study treatment
You may not qualify if:
- Spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention
- Any unresolved toxicity Grade 2 or more according to National cancer institute common terminology criteria for adverse events( NCI-CTCAE) version 5, from previous anticancer therapy with the exception of alopecia
- Inadequate hematological, liver and renal function
- Impaired cardiac function
- History of interstitial lung disease(ILD) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment
- Hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 millimeter of mercury (mmHg)
- Contraindication to the administration of osimertinib
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (179)
Yuma Regional Medical Center
Yuma, Arizona, 85364, United States
Compassionate Care Research Group Inc - Edinger Medical Group, Inc.
Fountain Valley, California, 92708, United States
Memorial Care
Long Beach, California, 90806, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Innovative Clinical Research Institute
Whittier, California, 92801, United States
Eastern Connecticut Hematology & Oncology Associates
Norwich, Connecticut, 06360, United States
Holy Cross
Fort Lauderdale, Florida, 33308, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Cancer Specialists of North Florida
Jacksonville, Florida, 32256, United States
Ocala Oncology
Ocala, Florida, 34474, United States
University Cancer and Blood Center
Athens, Georgia, 30607, United States
Hawaii Cancer Care
Honolulu, Hawaii, 96813, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845, United States
Community Health Network
Indianapolis, Indiana, 46250, United States
Beacon Health
South Bend, Indiana, 46601, United States
Norton Cancer Institute
Louisville, Kentucky, 40202, United States
Pontchartrain
Hammond, Louisiana, 70433, United States
Medstar Franklin Square Clinical Research Center
Baltimore, Maryland, 21237, United States
The Center for Cancer & Blood Disorders - Maryland
Bethesda, Maryland, 20817, United States
Frederick Health- James M Stockman Cancer Institute
Frederick, Maryland, 21702, United States
Boston Medical Center - Dept. Hematology/Oncology
Boston, Massachusetts, 02118, United States
Southcoast Center for Cancer Care
Fairhaven, Massachusetts, 02719, United States
Sparrow Hospital Herbert - Herman Cancer Center
Lansing, Michigan, 48912, United States
Central Care Cancer Center (CCCC)
Bolivar, Missouri, 65613, United States
St. Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
Mosaic Life Care
Saint Joseph, Missouri, 64507, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
New Jersey Cancer Care and Blood Disorders
Belleville, New Jersey, 07109, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
NYU Langone Clinical Cancer Center - NYU Langone Medical Center
New York, New York, 10016, United States
NYU Langone Clinical Cancer Center - NYU Langone Medical Cente
New York, New York, 10016, United States
Weill Cornell Medical College - Gastroenterology
New York, New York, 10021, United States
Southeastern Medical Oncology Center
Goldsboro, North Carolina, 27534, United States
University Hospitals Seidman
Cleveland, Ohio, 44106, United States
OhioHealth
Columbus, Ohio, 43214, United States
Oklahoma Cancer Specialists and Research Institute
Tulsa, Oklahoma, 74146, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Sanford Health
Sioux Falls, South Dakota, 57104, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57108, United States
Baptist Cancer Center
Memphis, Tennessee, 38120, United States
Tennessee Oncology
Nashville, Tennessee, 37201, United States
Mary Crowley Cancer Research
Dallas, Texas, 75230, United States
University of Texas MD Anderson Cancer Center - Unit 432 Thoracic Head and Neck Medical Oncology
Houston, Texas, 77030, United States
Community Cancer Trials of Utah
Ogden, Utah, 84405, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Hematology Oncology Associates of Fredericksburg
Fredericksburg, Virginia, 22408, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
UZ Antwerpen - Department of Oncology
Edegem, Belgium
UZ Leuven
Gasthuisberg, Belgium
AZ Delta
Roeselare, Belgium
Beijing Hospital
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Peking University Cancer Hospital
Beijing, China
Jilin Cancer Hospital - Oncology
Changchun, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Fujian Cancer Hospital
Fuzhou, China
Guangdong General Hospital
Guangzhou, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Affiliated Tumor Hospital of Harbin Medical University
Harbin, China
Anhui Chest Hospital
Hefei, China
Linyi Tumor Hospital
Linyi, China
Jiangsu Province Hospital
Nanjing, China
Shanghai Cancer Hospital, Fudan University
Shanghai, China
Shanghai Chest Hospital
Shanghai, China
Liaoning Cancer Hospital & Institute
Shenyang, China
The Affiliated Cancer Hospital of Xinjiang Medical university
Ürümqi, China
Hubei Cancer Hospital
Wuhan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Centre Francois Baclesse - Service d'Oncologie Medicale
Caen, France
Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie
Créteil, France
CHU Limoges - Hôpital Dupuytren - Unite d'Oncologie Thoracique et Cutanée
Limoges, France
Centre Léon Bérard
Lyon, France
Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie
Nord, France
Hopital Tenon - service pneumologie
Paris, France
Hospital Cochin Service, Service de Pneumologie et Mucoviscidose
Paris, France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Maison du Ha
Pessac, France
CHU de Toulouse - Hôpital Larrey - Service de Pneumologie et Oncologie Pneumologique
Toulouse, France
Universitaetsklinikum Koeln - Innere Medizin I, Onkologie, Haematologie
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, Germany
Asklepios Fachkliniken Muenchen-Gauting - Abteilung internistische Onkologie
Gauting, Germany
Universitaetsklinikum Giessen und Marburg GmbH Standort Giessen
Giessen, Germany
Universitaetsmedizin Goettingen
Göttingen, Germany
Evangelisches Krankenhaus Hamm gGmbH
Hamm, Germany
Evangelisches Krankenhaus Hamm GmbH
Hamm, Germany
Thoraxklinik-Heidelberg gGmbH
Heidelberg, Germany
Staedtisches Krankenhaus Kiel
Kiel, Germany
POIS Leipzig GbR
Leipzig, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Lübeck, Germany
Pius-Hospital Oldenburg - Klinik f. Haematologie und Onkologie
Oldenburg, Germany
Missionsärztliche Klinik
Würzburg, Germany
Queen Elizabeth Hospital - Department of Medicine
Hong Kong, Hong Kong
The University of Hong Kong
Hong Kong, Hong Kong
The Chinese University of Hong Kong - Emergency Medicine
Shatin, Hong Kong
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
Lazio, Italy
IEO Istituto Europeo di Oncologia
Milan, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo) - U.O Oncologia Medica
Monza, Italy
Ospedale Monaldi
Naples, Italy
IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2
Padua, Italy
AO Ospedali Riuniti Cervello - Presidio Villa Sofia - U.O.S. di Neuroimmunologia
Palermo, Italy
Azienda Ospedaliero Universitaria Pisana - U.O. Pneumologia II
Pisa, Italy
Istituto Nazionale Tumori Regina Elena IRCCS - S.C. Oncologia Medica B
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi) - Oncologia Medica
Varese, Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - U.O.C. Oncologia
Verona, Italy
Hamamatsu University School of Medicine, University Hospital - Dept of Respiratory Medicine
Hamamatsu, Japan
Saitama Cancer Center
Kitaadachi-gun, Japan
Kurume University Hospital
Kurume-shi, Japan
Nagoya University Hospital - Dept of Respiratory Medicine
Nagoya, Japan
Niigata Cancer Center Hospital - Dept of Internal Medicine
Niigata, Japan
Hyogo College of Medicine Hospital - Dept of Respiratory Medicine
Nishinomiya-shi, Japan
Okayama University Hospital - Dept of Respiratory Medicine/Allergy
Okayama, Japan
Osaka City General Hospital
Osaka, Japan
Kindai University Hospital
Osakasayama-shi, Japan
NHO Yamaguchi - Ube Medical Center
Ube-shi, Japan
Kanagawa Cancer Center - Dept of Respiratory Medicine
Yokohama, Japan
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Beacon International Specialist Centre Sdn Bhd
Kuala Selangor, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, Malaysia
Hospital Pulau Pinang - Clinic Respiratory
Pulau Pinang, Malaysia
The Netherlands Cancer Institute
Amsterdam, Netherlands
Universitair Medisch Centrum Groningen - Department of Internal Medicine
Groningen, Netherlands
Maastricht University Medical Center - Dept of Medical Oncology
Maastricht, Netherlands
SBHI "Krasnoyarsk Regional Oncology Dispensary n.a. A.I. Kryzhanovsky"
Krasnoyarsk, Russia
"VitaMed" LLC
Moscow, Russia
LLC "Tonus"
Nizniy Novgorod, Russia
BHI of Omsk region "Clinical Oncology Dispensary"
Omsk, Russia
LLC "ClinicaUZI4D"
Pyatigorsk, Russia
FBI "Scientific Research Institute of Oncology n. a. N. N. Petrov"
Saint Petersburg, Russia
Pavlov First Saint Petersburg State Medical University - Research Institute of Pulmunology
Saint Petersburg, Russia
Icon Cancer Centre
Connexion, Singapore
National Cancer Centre - Medical Oncology Pharmacy
Singapore, Singapore
Tan Tock Seng Hospital - CTRU/OCS, Research
Singapore, Singapore
National Cancer Center
Goyang-si, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
ICO Badalona - Hospital Germans Trias i Pujol - Servicio de Oncologia Medica
Badalona, Spain
Hospital del Mar - Servicio de Oncologia
Barcelona, Spain
Hospital Universitari Dexeus - Servicio de Oncologia Medica
Barcelona, Spain
Hospital Universitari Quiron Dexeus - Servicio de Oncologia Medica
Barcelona, Spain
Hospital Universitari Vall d'Hebron - Dept of Oncology
Barcelona, Spain
ICO l´Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
L'Hospitalet de Llobregat, Spain
Hospital Universitario Materno-Infantil de Canarias - Servicio de Oncologia
Las Palmas de Gran Canaria, Spain
Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia
Madrid, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital Universitari Son Espases - Servicio de Oncologia Medica
Palma, Spain
Hospital Universitario Quiron Madrid - Unidad Integral de Oncologia
Pozuelo de Alarcón, Spain
Hospital Universitario Virgen Macarena - Servicio de Oncologia
Seville, Spain
Hospital Universitari i Politecnic La Fe - Servicio de Oncologia Medica
Valencia, Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Medical Center, Liou Ying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Siriraj Hospital
Bangkoknoi, Thailand
Songklanagarind Hospital
Hat Yai, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Thailand
King Chulalongkorn Memorial Hospital
Pathumwan, Thailand
Bach Mai Hospital
Hanoi, Vietnam
K Hospital
Hanoi, Vietnam
National Lungs Hospital
Hanoi, Vietnam
Cho Ray Hospital
Ho Chi Minh City, Vietnam
HCMC Oncology Hospital
Ho Chi Minh City, Vietnam
Pham Ngoc Thach Hospital
Ho Chi Minh City, Vietnam
Related Publications (3)
F Smit E, Dooms C, Raskin J, Nadal E, Tho LM, Le X, Mazieres J, S Hin H, Morise M, W Zhu V, Tan D, H Holmberg K, Ellers-Lenz B, Adrian S, Brutlach S, Schumacher KM, Karachaliou N, Wu YL. INSIGHT 2: a phase II study of tepotinib plus osimertinib in MET-amplified NSCLC and first-line osimertinib resistance. Future Oncol. 2022 Mar;18(9):1039-1054. doi: 10.2217/fon-2021-1406. Epub 2021 Dec 17.
PMID: 34918545BACKGROUNDWu YL, Guarneri V, Voon PJ, Lim BK, Yang JJ, Wislez M, Huang C, Liam CK, Mazieres J, Tho LM, Hayashi H, Nhung NV, Chia PL, de Marinis F, Raskin J, Zhou Q, Finocchiaro G, Le AT, Wang J, Dooms C, Kato T, Nadal E, Hin HS, Smit EF, Wermke M, Tan D, Morise M, O'Brate A, Adrian S, Pfeiffer BM, Stroh C, Juraeva D, Strotmann R, Goteti K, Berghoff K, Ellers-Lenz B, Karachaliou N, Le X, Kim TM; INSIGHT 2 investigators. Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2024 Aug;25(8):989-1002. doi: 10.1016/S1470-2045(24)00270-5.
PMID: 39089305DERIVEDHallick J, Baird AM, Falchook G, Le X, Hong D, Viteri S, Raskin J, Reinmuth N, Vlassak S, Militaru M, Paik PK. Plain language summary of the development of tepotinib: a treatment for a subtype of non-small cell lung cancer called MET exon 14 skipping. Future Oncol. 2023 Mar;19(10):683-696. doi: 10.2217/fon-2022-1035. Epub 2023 Mar 31.
PMID: 36999526DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Communication Center
- Organization
- Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Officials
- STUDY DIRECTOR
Medical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2019
First Posted
May 7, 2019
Study Start
September 19, 2019
Primary Completion
May 11, 2023
Study Completion
May 1, 2026
Last Updated
February 27, 2026
Results First Posted
June 4, 2024
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
- Access Criteria
- Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.
Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, EMD Serono will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html