Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study

TJ. Phillips, C. Carlo-Stella, F. Morschhauser, E. Bachy, M. Crump, M. Trněný, NL. Bartlett, J. Zaucha, T. Wrobel, F. Offner, K. Humphrey, J. Relf, A. Filézac de L'Etang, DJ. Carlile, B. Byrne, N. Qayum, L. Lundberg, M. Dickinson

. 2025 ; 43 (3) : 318-328. [pub] 20241004

Jazyk angličtina Země Spojené státy americké

Typ dokumentu časopisecké články, klinické zkoušky, fáze I, klinické zkoušky, fáze II, multicentrická studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc25010229

PURPOSE: Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696) evaluated glofitamab monotherapy in patients with R/R B-cell lymphomas, with obinutuzumab pretreatment (Gpt) to mitigate the risk of cytokine release syndrome (CRS) with glofitamab. We present data for patients with R/R MCL. METHODS: Eligible patients with R/R MCL (at least one previous therapy) received Gpt (1,000 or 2,000 mg) 7 days before the first glofitamab dose (single dose or split over 2 days if required). Glofitamab step-up dosing was administered once a day on days 8 (2.5 mg) and 15 (10 mg) of cycle 1, with a target dose of 16 or 30 mg once every 3 weeks from cycle 2 day 1 onward, for 12 cycles. Efficacy end points included investigator-assessed complete response (CR) rate, overall response rate (ORR), and duration of CR. RESULTS: Of 61 enrolled patients, 60 were evaluable for safety and efficacy. Patients had received a median of two previous therapies (range, 1-5). CR rate and ORR were 78.3% (95% CI, 65.8 to 87.9) and 85.0% (95% CI, 73.4 to 92.9), respectively. In patients who had received previous treatment with a Bruton tyrosine kinase inhibitor (n = 31), CR rate was 71.0% (95% CI, 52.0 to 85.8) and ORR was 74.2% (95% CI, 55.4 to 88.1). CRS after glofitamab administration occurred in 70.0% of patients, with a lower incidence in the 2,000 mg (63.6% [grade ≥2, 22.7%]) versus 1,000 mg (87.5%; grade ≥2, 62.5%) Gpt cohort. Four adverse events led to glofitamab withdrawal (all infections). CONCLUSION: Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc25010229
003      
CZ-PrNML
005      
20250429134656.0
007      
ta
008      
250415s2025 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/JCO.23.02470 $2 doi
035    __
$a (PubMed)39365960
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Phillips, Tycel Jovelle $u University of Michigan Medical School, Ann Arbor, MI $u Current address: City of Hope National Medical Center, Duarte, CA $1 https://orcid.org/0000000321439672
245    10
$a Glofitamab in Relapsed/Refractory Mantle Cell Lymphoma: Results From a Phase I/II Study / $c TJ. Phillips, C. Carlo-Stella, F. Morschhauser, E. Bachy, M. Crump, M. Trněný, NL. Bartlett, J. Zaucha, T. Wrobel, F. Offner, K. Humphrey, J. Relf, A. Filézac de L'Etang, DJ. Carlile, B. Byrne, N. Qayum, L. Lundberg, M. Dickinson
520    9_
$a PURPOSE: Patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) have a poor prognosis. The phase I/II NP30179 study (ClinicalTrials.gov identifier: NCT03075696) evaluated glofitamab monotherapy in patients with R/R B-cell lymphomas, with obinutuzumab pretreatment (Gpt) to mitigate the risk of cytokine release syndrome (CRS) with glofitamab. We present data for patients with R/R MCL. METHODS: Eligible patients with R/R MCL (at least one previous therapy) received Gpt (1,000 or 2,000 mg) 7 days before the first glofitamab dose (single dose or split over 2 days if required). Glofitamab step-up dosing was administered once a day on days 8 (2.5 mg) and 15 (10 mg) of cycle 1, with a target dose of 16 or 30 mg once every 3 weeks from cycle 2 day 1 onward, for 12 cycles. Efficacy end points included investigator-assessed complete response (CR) rate, overall response rate (ORR), and duration of CR. RESULTS: Of 61 enrolled patients, 60 were evaluable for safety and efficacy. Patients had received a median of two previous therapies (range, 1-5). CR rate and ORR were 78.3% (95% CI, 65.8 to 87.9) and 85.0% (95% CI, 73.4 to 92.9), respectively. In patients who had received previous treatment with a Bruton tyrosine kinase inhibitor (n = 31), CR rate was 71.0% (95% CI, 52.0 to 85.8) and ORR was 74.2% (95% CI, 55.4 to 88.1). CRS after glofitamab administration occurred in 70.0% of patients, with a lower incidence in the 2,000 mg (63.6% [grade ≥2, 22.7%]) versus 1,000 mg (87.5%; grade ≥2, 62.5%) Gpt cohort. Four adverse events led to glofitamab withdrawal (all infections). CONCLUSION: Fixed-duration glofitamab induced high CR rates in heavily pretreated patients with R/R MCL; the safety profile was manageable with appropriate support.
650    _2
$a lidé $7 D006801
650    12
$a lymfom z plášťových buněk $x farmakoterapie $x patologie $7 D020522
650    _2
$a mužské pohlaví $7 D008297
650    _2
$a senioři $7 D000368
650    _2
$a lidé středního věku $7 D008875
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a senioři nad 80 let $7 D000369
650    _2
$a humanizované monoklonální protilátky $x aplikace a dávkování $x terapeutické užití $x škodlivé účinky $7 D061067
650    _2
$a dospělí $7 D000328
650    _2
$a lokální recidiva nádoru $x farmakoterapie $7 D009364
655    _2
$a časopisecké články $7 D016428
655    _2
$a klinické zkoušky, fáze I $7 D017426
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a multicentrická studie $7 D016448
700    1_
$a Carlo-Stella, Carmelo $u Department of Biomedical Sciences, Humanitas University and IRCCS Humanitas Research Hospital, Milano, Italy $1 https://orcid.org/0000000331440124
700    1_
$a Morschhauser, Franck $u CHU Lille, Service des Maladies du Sang, Lille, France $1 https://orcid.org/0000000237149824
700    1_
$a Bachy, Emmanuel $u Hospices Civils de Lyon and Université Claude Bernard, Pierre-Bénite, France $1 https://orcid.org/0000000326947510
700    1_
$a Crump, Michael $u Princess Margaret Cancer Centre, Toronto, ON, Canada
700    1_
$a Trněný, Marek $u First Faculty of Medicine, Charles University, General Hospital, Prague, Czech Republic $1 https://orcid.org/0000000269526073 $7 nlk20000083659
700    1_
$a Bartlett, Nancy L $u Siteman Cancer Center, Washington University, St Louis, MO $1 https://orcid.org/000000018470394X
700    1_
$a Zaucha, Jan $u Medical University of Gdańsk, Gdańsk, Poland
700    1_
$a Wrobel, Tomasz $u Wroclaw Medical University, Wroclaw, Poland
700    1_
$a Offner, Fritz $u Department of Hematology, Universitair Ziekenhuis, Gent, Belgium
700    1_
$a Humphrey, Kathryn $u Roche Products Ltd, Welwyn Garden City, United Kingdom
700    1_
$a Relf, James $u Roche Products Ltd, Welwyn Garden City, United Kingdom
700    1_
$a Filézac de L'Etang, Audrey $u F. Hoffmann-La Roche Ltd, Basel, Switzerland
700    1_
$a Carlile, David J $u Roche Products Ltd, Welwyn Garden City, United Kingdom
700    1_
$a Byrne, Ben $u Roche Products Ltd, Welwyn Garden City, United Kingdom
700    1_
$a Qayum, Naseer $u Roche Products Ltd, Welwyn Garden City, United Kingdom
700    1_
$a Lundberg, Linda $u F. Hoffmann-La Roche Ltd, Basel, Switzerland
700    1_
$a Dickinson, Michael $u Sir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, VIC, Australia $1 https://orcid.org/0000000214925966
773    0_
$w MED00002596 $t Journal of clinical oncology $x 1527-7755 $g Roč. 43, č. 3 (2025), s. 318-328
856    41
$u https://pubmed.ncbi.nlm.nih.gov/39365960 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20250415 $b ABA008
991    __
$a 20250429134652 $b ABA008
999    __
$a ok $b bmc $g 2311537 $s 1247310
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2025 $b 43 $c 3 $d 318-328 $e 20241004 $i 1527-7755 $m Journal of clinical oncology $n J Clin Oncol $x MED00002596
LZP    __
$a Pubmed-20250415

Najít záznam

Citační ukazatele

Možnosti archivace