Må kjøpes vel? 6$
Introduction: Lutetium (177Lu)
lilotomab satetraxetan (Betalutin®) is a novel beta-emitting anti-CD37
ARC in a ready-to-use formulation. CD37 is highly expressed (>90%) in
B-cell NHL, providing an alternative target to CD20.
LYMRIT 37-01 is a
phase I/II, open-label, dose-escalation study to evaluate the safety and
preliminary efficacy of Betalutin® monotherapy in patients (pts) with
relapsed non-Hodgkin’s lymphoma (NHL). We present updated safety and
efficacy data for all pts as of February 13, 2017.
Methods:
Pts with histologically confirmed NHL (follicular (FL) grade I–IIIA,
mantle cell (MCL) and marginal zone (MZL)) relapsing after ≥1 prior
therapy with <25% bone marrow involvement, platelets (plt)
150 × 109/L, no prior SCT/RIT, and a life expectancy of
≥3 months were enrolled into 1 of 4 dose-escalation arms (part 1) to
determine the optimal lilotomab pre-dose and Betalutin® regimen for
further evaluation in an expanded cohort (part 2). All pts received
pre-treatment with rituximab. Responses were assessed using Cheson IWG
response criteria (including CT and PET-CT scans) beginning at week 12.
Results:
A total of 56 patients have been enrolled; 43 are evaluable for safety
and 38 for efficacy. Patients who had reached their platelet/neutrophil
nadir were included in the safety assessment.
NHL subtypes were FL (n = 31), MCL (n = 4), and MZL (n = 8).
The number of prior therapies ranged from 1 to 8.
A total of 38 pts
received lilotomab 40 mg pre-dose (Arm 1).
A total of 10 pts received lilotomab 100 mg/m2 pre-dose (Arm 4).
Arms 2 and 3 without lilotomab pre-dosing were discontinued.
Treatment-emergent grade 3/4 AEs in ≥2 pts were neutropenia (42/19%), thrombocytopenia (28/23%),
leukopenia (44/7%) and lymphocytopenia (35/2%); all were reversible.
Treatment emergent SAEs in ≥2 pts were thrombocytopenia (n = 2) and atrial fibrillation (n = 2). For patients receiving 15 MBq/kg Betalutin®, mean platelet and neutrophil nadirs were 62 and 1.0 × 109/L with 40 mg lilotomab pre-dose (n = 25) compared to 124 and 2.1 × 109/L with 100 mg/m2 (n = 3) lilotomab pre-dose, respectively.
The ORR for all pts was 63% (CR 29%) and 65% (CR 27%) for FL pts. Tumor
reductions were seen in 84%. The ORR for 22 pts receiving lilotomab
40 mg/15 MBq/kg Betalutin® (Arm 1 MTD) was 64% (CR 36%).
Best ResponseAll (N=38)FL (N=26)
Overall response rate (CR+PR)24 (63%)17 (65%)CR11 (29%)7 (27%)PR13 (34%)10 (38%)SD6 (16%)3 (12%)PD8 (21%)6 (23%)
Not evaluable11
Conclusions:
Betalutin® has promising single agent activity in relapsed NHL and was
generally well tolerated. A higher lilotomab pre-dose may allow
administration of a higher and potentially more efficacious dose of
Betalutin®—evaluation is ongoing and updated safety/efficacy results
will be reported at the meeting.
Keywords: indolent lymphoma; non-Hodgkin lymphoma (NHL); radioimmunotherapy (RIT).
som lekmann tolker jeg det der positivt 
Behandlet 7 pasienter med 20/100 siden ASH(?)
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Første pasient arm 4 ble vel børsmeldt 18. mai 2016?
Edit: Feiltolket spørsmålet ditt. 
A higher lilotomab pre-dose may allow
administration of a higher and potentially more efficacious dose of
Betalutin®—evaluation is ongoing and updated safety/efficacy results
will be reported at the meeting.
----> Da får vi data fra 20/100 i Lugano
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Hører du det? Høres ut som en 
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var sånn jeg tolket det også. Håpe det blir litt fyr i lunta nå da
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Ikke nødvendigvis 20/100 vel? Kjørte de ikke 15/100 og eller tar jeg feil nå?
3 av de 10 er 15/100 (ASH)
@Sponplate - “higher and potentially more efficacious dose of
Betalutin®” Jeg antar at dette er fra 15 til 20?
Ja enig. Bare lurte på om vi kunne anta at de 7 siste etter ASH var 20/100 eller om noen av de også er 15/100.
Time will show! Men forventningene til 20/100 dataene er skyhøye. Det er kanskje slik at det er disse dataene som gjorde at de fikk godkjent abstraktet? Dette er selvfølgelig spekulasjoner, men NANO reiser ikke til Lugano kun for å bekrefte tallene de presenterte på ASH.
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Posteren slippes 12:00 CET 14.juni.
Noe merkverdig at det er midt i børsdagen.
Kanskje blander de tidssoner igjen også…
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Det vil si kl: 13:00 i Norge😂
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Syns det var lite nytt og dra ut av abstraktet. Veldig spent på selve posteren og ble positivt overrasket over antall pasienter. Samtidig kan kanskje dette gjøre fallhøyden større hvis resultatene ikke svarer til folks forventninger. Gleder meg veldig til å se effektdata fra flere pasienter og ikke minst om de har med effektdata for 20/100. Hvis de klarer å reprodusere de gode nøytrofildataene fra tidligere predoseringer med 100, samt har lik/bedre effekt tror jeg dette kan bli veldig bra. Forøvrig er det garantert mye annet spennende som skal presenteres på konferansen og som vil være tilgjengeliggjort nå.
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De hadde jo meget gode effektdata på 20/40, og 15/100 hadde bedre safety. Tone Kvåle sa at predoseringen ikke hadde noen negativ effekt på medisinen, kun bedre safety. Innen lørdag 17 så vet vi mer. (Evt allerede onsdag 14?)
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