Dienstag, 3. August 2021
Navigation öffnen
Anzeige:
Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE

A Study of Lazertinib as Monotherapy or in Combination With Amivantamab in Participants With Advanced Non-small Cell Lung Cancer

Rekrutierend

NCT-Nummer:
NCT04077463

Studienbeginn:
September 2019

Letztes Update:
03.08.2021

Wirkstoff:
Lazertinib, Amivantamab, Carboplatin, Pemetrexed

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Janssen Research & Development, LLC

Collaborator:
-

Studienleiter

Janssen Research & Development, LLC Clinical Trial
Study Director
Janssen Research & Development, LLC

Kontakt

Studienlocations
(3 von 83)

Evangelische Lungenklinik Berlin
13125 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Klinikum der Johann Wolfgang Goethe-Universität
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Gauting GmbH - Asklepios Fachkliniken München-Gauting
82131 Gauting
(Bayern)
GermanyRekrutierend» Google-Maps
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
06120 Halle (Saale)
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Thoraxklinik am Universitätsklinikum Heidelberg
69126 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Lungenklinik Hemer
58675 Hemer
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Lungenkrebszentrum Uniklinik Köln / Solingen
Kerpener Straße 62
50937 Köln
DeutschlandRekrutierend» Google-Maps
Kliniiken der Stadt Köln gGmbH, Krankenhaus Köln-Mehrheim
51109 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Pius-Hospital Oldenburg
26121 Oldenburg
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Robert-Bosch-Krankenhaus - Klinik Schillerhoehe
70376 Stuttgart
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
USC - Norris Comprehensive Cancer Center
90089-9173 Los Angeles
United StatesRekrutierend» Google-Maps
University of California, Irvine
92868 Orange
United StatesRekrutierend» Google-Maps
UCSF Helen Diller Comprehensive
94158 San Francisco
United StatesRekrutierend» Google-Maps
Stanford University Medical Center
94305 Stanford
United StatesRekrutierend» Google-Maps
Cedars Sinai Medical Center
90048 West Hollywood
United StatesRekrutierend» Google-Maps
H. Lee Moffitt Cancer & Research Institute
33612 Tampa
United StatesRekrutierend» Google-Maps
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
21231 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Boston University Medical Center
02118 Boston
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
Barbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesRekrutierend» Google-Maps
Washington University School of Medicine
63110 Saint Louis
United StatesRekrutierend» Google-Maps
Langone Health at NYC University, NYU School of Medicine
10016 New York
United StatesRekrutierend» Google-Maps
Columbia University Medical Center
10032 New York
United StatesRekrutierend» Google-Maps
Providence Portland Medical Center
97213 Portland
United StatesRekrutierend» Google-Maps
University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine
19104 Philadelphia
United StatesRekrutierend» Google-Maps
Huntsman Cancer Institute
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
Virginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
University of Washington
98109 Seattle
United StatesRekrutierend» Google-Maps
The First Bethune Hospital of Jilin University
130021 Changchun
ChinaRekrutierend» Google-Maps
Hunan Cancer hospital
410013 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
West China School of Medicine/West China Hospital, Sichuan University
610041 Chengdu
ChinaRekrutierend» Google-Maps
The Fifth Affiliated Hospital of Guangzhou Medical University
440112 Guangzhou
ChinaRekrutierend» Google-Maps
The First Affiliated Hospital of NanChang University
330006 Nanchang
ChinaNoch nicht rekrutierend» Google-Maps
Shengjing Hospital of China Medical University
110022 Shenyang
ChinaRekrutierend» Google-Maps
Tianjin Medical University Cancer Institute and Hospital
300000 Tianjin
ChinaRekrutierend» Google-Maps
Union Hospital Tongji Medical College of Huazhong University of Science and Technology
430022 Wuhan
ChinaRekrutierend» Google-Maps
First Affiliated Hospital, Xi'an Jiaotong University
710061 Xi'an
ChinaRekrutierend» Google-Maps
Institut Gustave Roussy
94805 Villejuif Cedex
FranceRekrutierend» Google-Maps
IRCCS Ospedale San Raffaele
20132 Milano
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
National Cancer Center Hospital
104-0045 Chuo-Ku
JapanRekrutierend» Google-Maps
Kansai Medical University Hospital
573-1191 Hirakata
JapanRekrutierend» Google-Maps
National Cancer Center Hospital East
277-8577 Kashiwa
JapanRekrutierend» Google-Maps
Kobe City Medical Center General Hospital
650-0047 Kobe-City,
JapanRekrutierend» Google-Maps
Aichi Cancer Center Hospital
464-8681 Nagoya-Shi
JapanRekrutierend» Google-Maps
Okayama University Hospital
700-8558 Okayama
JapanRekrutierend» Google-Maps
Seoul National University Bundang Hospital
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Oncologic Hospital, Puerto Rico Medical Center
OO935 Rio Piedras
Puerto RicoRekrutierend» Google-Maps
Inst. Cat. Doncologia-H Duran I Reynals
08908 Hospitalet de Llobregat, Barcelona
SpainZurückgezogen» Google-Maps
Hosp. Gral. Univ. Gregorio Marañon
28009 Madrid
SpainRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
Chung Shan Medical University Hospital
402 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital
704 Tainan
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei City
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Lung cancer is one of the most common types of cancer and is also the most common cause of

death from cancer. NSCLC accounts for 85 percent (%) to 90% of lung cancers. Lazertinib is an

oral, highly potent, mutant-selective, and irreversible EGFR-tyrosine kinase inhibitor (TKI)

targeting both, the T790M mutation and activating EGFR mutations while sparing wild type

EGFR. JNJ-61186372 (also referred to as amivantamab), is a low fucose, fully human

immunoglobulin G1(IgG1)-based bispecific antibody. As a third generation EGFR-TKI targeting

activating EGFR mutations, lazertinib has a distinct mechanism of action from JNJ-61186372,

which targets the extracellular domains of both the EGFR and cMet proteins. The distinct

mechanisms of action of lazertinib and JNJ-61186372 suggests potential to improve clinical

outcomes through the combination of these two molecules. Phase 1 and 1b lazertinib +

amivantamab, and Phase 1b LACP combination cohort are divided into 2 periods: screening and

treatment period whereas Phase 1b expansion cohorts are divided into 3 periods: screening,

treatment, and post-treatment follow up period. Safety assessment will include adverse events

(AEs), serious adverse events (SAEs), physical examinations, Eastern Cooperative Oncology

Group (ECOG) criteria for performance status, laboratory tests, vital signs,

electrocardiograms, chest x-ray, baseline ophthalmologic examination (Phase 1b Expansion

Cohorts), echocardiography or multigated acquisition, and concomitant medication usage. The

overall duration of the study will be up to 5 years and 2 months.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Phase 1 and Phase 1b lazertinib+Amivantamab combination cohorts: Histologically or

cytologically confirmed non-small cell lung cancer (NSCLC) with previously epidermal

growth factor receptor (EGFR) mutation (identified locally in a Clinical Laboratory

Improvement Amendments [CLIA]-certified laboratory [or equivalent]) that is metastatic

or unresectable, and have progressed after standard of care front-line therapy, and

exhausted available options with targeted therapy. A participant who has refused all

other currently available therapeutic options is allowed to enroll

- For the Phase 1b Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)

combination cohort: histologically or cytologically confirmed advanced or metastatic

EGFR-mutated NSCLC who have progressed on or after an EGFR-TKI as the most recent line

of treatment with a maximum of 3 prior lines of therapy in the metastatic setting

allowed

- For all expansion cohorts, the EGFR mutation must have been previously histologically

or cytologically characterized, as performed by a CLIA-certified (US sites) or an

accredited (outside of US) local laboratory, with a copy of the mutation analysis

being submitted during screening (Phase 1b expansion Cohort B, C and D)

1. Expansion Cohort A: Participant must have advanced or metastatic EGFR-mutated

non-small cell lung cancer (NSCLC) that has progressed on prior treatment with

osimertinib in the first or second line, followed by progression on a

platinum-based chemotherapy regimen as the last line of therapy prior to study

enrollment. Prior use of first or second generation EGFR tyrosine kinase

inhibitor (TKI) is allowed if administered prior to osimertinib

2. Expansion Cohort B: Participant must have previously treated, advanced or

metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation.

Participants should have been treated with standard of care, platinum-based

chemotherapy regimens, but may have treated with approved EGFR TKI,

investigational EGFR, or immunotherapy agents if refusing front line

platinum-based chemotherapy standard of care. Up to 3 lines of prior systemic

anti-cancer treatment are allowed

3. Expansion Cohort C: Participant must have advanced or metastatic NSCLC

characterized by an uncommon activating mutation Additional uncommon EGFR

mutations/alterations, beyond those listed above, may be considered for

enrollment after agreement with the medical monitor. Participants may be

treatment naïve or have been treated with one prior line of therapy which must be

a first or second generation TKI (that is gefitinib, erlotinib, afatinib) in the

most recent line of therapy. Prior chemotherapy is allowed if administered prior

to EGFR TKI therapy, or as the only systemic anti-cancer therapy prior to study

enrollment. Up to 2 lines of prior systemic anti-cancer treatment are allowed

4. Expansion Cohort D: Participant must have advanced or metastatic EGFR-mutated

NSCLC (EGFR Exon19 deletion or L858R) that has progressed on prior treatment with

osimertinib in the first or second line (after first- or second-generation EGFR

TKI), as the immediate prior line of therapy. Only previous treatment in the

metastatic setting with a first, second, or third generation EGFR TKI is allowed

- Evaluable disease

- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1

- Participants must meet the study protocol defined laboratory criteria without having a

history of red blood cell transfusion, platelet transfusion, or granulocyte-colony

stimulating factor support within 7 days prior to the date of the test

- A woman of childbearing potential: Must have a negative serum beta human chorionic

gonadotropin at screening; Must agree not to breast-feed during the study and for 6

months after the last dose of study intervention. (Enrollment is not allowed even if a

woman who is breast-feeding stops breast-feeding); Must agree not to donate eggs (ova,

oocytes) for the purposes of assisted reproduction during the study and for 6 months

after receiving the last dose of study intervention

Exclusion Criteria:

- Participant has an uncontrolled illness, including but not limited uncontrolled

diabetes, ongoing or active infection (includes infection requiring treatment with

antimicrobial therapy [participants will be required to complete antibiotics week

prior to study treatment] or diagnosed or suspected viral infection); active bleeding

diathesis; Impaired oxygenation requiring continuous oxygen supplementation;

Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to

swallow the formulated product, or previous significant bowel resection that would

preclude adequate absorption of study treatment; or psychiatric illness or any other

circumstances including (social circumstances) that would limit compliance with study

requirements. Any ophthalmologic condition that is either clinically unstable or

requires treatment

- Prior treatment with antiPD-1 or anti Programmed death-ligand 1 (PD-L1) antibody

within 6 weeks of planned first dose of study intervention

- Untreated brain or other central nervous system (CNS) metastases whether symptomatic

or asymptomatic. Participants who have completed definitive therapy, are not on

steroids, and have a stable clinical status for at least 2 weeks prior to study

treatment may be eligible for Phase 1b expansion cohorts. If brain metastases are

diagnosed on Screening imaging, the participant may be enrolled, or rescreened for

eligibility, after definitive treatment if above criteria are met

- Any Toxicities from prior anticancer therapy must have resolved to common terminology

criteria for adverse events (CTCAE) version 5.0 Grade 1 or baseline level (except for

alopecia [any grade], Grade <=2 peripheral neuropathy, and Grade <=2 hypothyroidism

stable on hormone replacement therapy)

- Allergies, hypersensitivity, or intolerance to Lazertinib or JNJ-61186372 or their

excipients. For the LACP combination cohort: participant has a contraindication for

the use of carboplatin or pemetrexed (refer to local prescribing information for each

agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12

or folic acid

Studien-Rationale

Primary outcome:

1. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1) (Time Frame - Until the end of first cycle (21 days for Phase 1)):
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

2. Percentage of Participants with Dose-Limiting Toxicity (DLT) (Phase 1b) (Time Frame - Until the end of first cycle (28 days for Phase 1b)):
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

3. Overall Response Rate (ORR) (Phase 1b expansion) (Time Frame - Up to 2 years):
ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria.

4. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1b Expansion) (Time Frame - Up to 2 years):
Adverse events (AEs) defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Criteria Version 5.0 in participants treated at the RP2CD regimen of Lazertinib and Amivantamab combination therapy. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

5. Percentage of Participants with DLT (Phase 1b combination Lazertinib, Amivantamab, Platinum-doublet chemotherapy [LACP]) (Time Frame - Until the end of first cycle (21 days for Phase 1b combination LACP)):
DLTs are defined as certain non-hematologic and hematologic toxicities of Grade 3 or higher.

6. Number of Participants with AEs as a Measure of Safety and Tolerability (Phase 1b combination LACP) (Time Frame - Up to 2 years):
AEs defined by the NCI-CTCAE criteria version 5.0 in participants treated with LACP combination regimen. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

7. Overall Response Rate (ORR) per RECIST version 1.1 (v1.1) with NGS Analysis of Circulating Tumor ctDNA, IHC Analysis of EGFR and MET Expression (Phase 1b Expansion Cohort D) (Time Frame - Up to 2 years):
ORR is defined as the percentage of participants who achieve either a complete (CR) or partial response (PR) as determined by the investigator using RECIST 1.1 criteria with Next Generation Sequencing (NGS) Analysis of Circulating Tumor Deoxyribonucleic Acid (ctDNA), Immunohistochemical (IHC) Analysis of Tumor Epidermal Growth Factor Receptor (EGFR) and MET Expression (Phase 1b Expansion Cohort D).

Secondary outcome:

1. Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (Phase 1 and Phase 1b) (Time Frame - Up to 1.8 years):
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

2. Plasma Concentration of Lazertinib (Phase 1 and Phase 1b) (Time Frame - Up to End of Treatment [EOT]) (30 days after last dose) (up to 1.8 years)):
Plasma samples will be analyzed to determine concentrations of Lazertinib.

3. Serum Concentration of Amivantamab (Phase 1b) (Time Frame - Up to EOT (30 days after last dose) (up to 1.8 years)):
Serum samples will be analyzed to determine concentrations of Amivantamab.

4. Number of Participants with Anti-drug Antibodies Against Amivantamab (Phase 1b) (Time Frame - Up to EOT (30 days after last dose) (up to 1.8 years)):
Number of participants with anti-drug antibodies against Amivantamab will be reported.

5. Progression free survival (PFS) (Phase 1b Expansion) (Time Frame - Up to 1.8 years (end of treatment)):
PFS is defined as the time from first infusion of study intervention to PD or death due to any cause.

6. Time to Treatment Failure (TTF) (Phase 1b Expansion) (Time Frame - Up to 2 years):
TTF is defined as the time from the first administration of the study intervention to discontinuation of treatment for any reason, including disease progression, treatment toxicity, death, and will be utilized to capture clinical benefit for patients continuing treatment beyond as determined by the investigator using RECIST 1.1 criteria.

7. Overall Survival (OS) (Phase 1b Expansion) (Time Frame - Up to 2 years):
OS is defined as the time from first infusion of study intervention to death due to any cause as determined by the investigator using RECIST 1.1 criteria.

8. Duration of Response (DOR) (Phase 1b expansion) (Time Frame - Up to 2 years):
DOR will be calculated as time from initial response of CR or PR to progressive disease (PD) or death due to any cause, whichever comes first, only for participants who achieve CR or PR as determined by the investigator using RECIST 1.1 criteria.

9. Clinical Benefit Rate (CBR) (Phase 1b expansion) (Time Frame - Up to 2 years):
CBR is defined as the percentage of participants achieving complete or partial response, or durable stable disease (duration of at least 11 weeks) as determined by the investigator using RECIST 1.1 criteria.

Studien-Arme

  • Experimental: Phase 1 (monotherapy dose escalation): Lazertinib
    Participants will receive Lazertinib monotherapy orally once daily (QD) in 21-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. The subsequent doses of Lazertinib will be assigned by the Study Evaluation Team (SET) according to the dose escalation strategy by Bayesian logistic regression model (BLRM).
  • Experimental: Phase 1b (combination): Lazertinib and Amivantamab
    Participants will receive Lazertinib and Amivantamab, after the safety of RP2D of Lazertinib is confirmed in the Phase 1, in 28-day cycles until documented evidence of disease progression, unacceptable toxicity, noncompliance, or withdrawal of consent, or the investigator decides to discontinue treatment, whichever comes first. This phase will start enrolling participants after the safety of Amivantamab is confirmed in Japanese participants in Study 61186372EDI1001 (NCT02609776).
  • Experimental: Phase 1b (combination): Lazertinib, Amivantamab and Platinum-doublet Chemotherapy (LACP)
    Participants will receive Lazertinib starting dose administered orally once daily (QD) in combination with Amivantamab, and doses of platinum-based chemotherapy (carboplatin and pemetrexed) per standard of care according to local guidance in a 21-day cycle for 4 cycles followed by maintenance with Lazertinib, Amivantamab and pemetrexed until disease progression or unacceptable toxicities.
  • Experimental: Phase 1b (expansion) Cohort A: Lazertinib and Amivantamab
    This cohort A will further characterize the safety, tolerability, and preliminary antitumor activity of Lazertinib and Amivantamab based combinations within specific NSCLC population "who have progressed after osimertinib and subsequent platinum-based chemotherapy, and platinum-based chemotherapy regimen as the last line of therapy prior to study enrollment. Prior use of first or second generation EGFR TKI is allowed if administered prior to osimertinib. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
  • Experimental: Phase 1b (expansion) Cohort B: Lazertinib and Amivantamab
    This Cohort B will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants previously treated with advanced or metastatic NSCLC with documented primary EGFR Exon 20ins activating mutation. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
  • Experimental: Phase 1b (expansion) Cohort C: Lazertinib and Amivantamab
    This Cohort C will further characterize the safety, tolerability and preliminary antitumor activity of Lazertinib and JNJ-61186372 combination in participants with uncommon EGFR mutations. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.
  • Experimental: Phase 1b (expansion) Cohort D: Lazertinib and Amivantamab
    Cohort D will seek to validate one or both potential biomarker strategies (next generation sequencing [NGS] and Immunohistochemical [IHC]), previously identified in Cohort E of Study 61186372EDI1001, in participants with osimertinib-relapsed, but chemotherapy-naive, EGFR Exon19del or L858R mutated NSCLC. Participants will receive at the RP2CD of Lazertinib orally QD and Amivantamab, every 7 days for the first 28 days cycle and every 2 weeks thereafter.

Geprüfte Regime

  • Lazertinib (JNJ-73841937):
    Lazertinib will be administered orally.
  • Amivantamab (JNJ-61186372):
    Amivantamab will be administered as an intravenous (IV) infusion.
  • Carboplatin:
    Carboplatin will be administered as IV infusion.
  • Pemetrexed:
    Pemetrexed will be administered as IV infusion.

Quelle: ClinicalTrials.gov


Das könnte Sie auch interessieren
EHA 2021
  • SCD: Häufigere und längere VOC-bedingte Krankenhausaufenthalte nach Vorgeschichte von VOC-Hospitalisierungen – Ergebnisse einer Beobachtungsstudie
  • Real-World-Daten des ERNEST-Registers untermauern Überlebensvorteil unter Ruxolitinib bei primärer und sekundärer Myelofibrose
  • I-WISh-Studie: Ärzte sehen TPO-RAs als beste Option, um anhaltende Remissionen bei ITP-Patienten zu erzielen
  • Phase-III-Studie REACH2 bei steroidrefraktärer akuter GvHD: Hohes Ansprechen auf Ruxolitinib auch nach Crossover
  • SCD: Neues digitales Schmerztagebuch zur tagesaktuellen Erfassung von VOCs wird in Beobachtungsstudie geprüft
  • Französische Real-World-Studie: Eltrombopag meist frühzeitig nach ITP-Diagnose im Rahmen eines Off-label-Use eingesetzt
  • Fortgeschrittene systemische Mastozytose: Französische Real-World-Studie bestätigt klinische Studiendaten zur Wirksamkeit von Midostaurin
  • CML-Management weitgehend leitliniengerecht, aber verbesserungsfähig – Ergebnisse einer Querschnittsbefragung bei britischen Hämatologen
  • Britische Real-World-Studie: Kardiovaskuläres Risikomanagement bei MPN-Patienten in der Primärversorgung nicht optimal
  • Myelofibrose: Früher Einsatz von Ruxolitinib unabhängig vom Ausmaß der Knochenmarkfibrose