Nei, denne gangen er risikoen for det nesten fraværende.
Pga:
Dataene som skal presenteres på ASH, er de som har skjedd mellom AARC16 i april og nå.
Disse har allerede blitt gjennomgått to ganger av en uavhengig sikkerhetskommite (Safety Review Comittee), som på bakgrunn av dataene skulle avgjøre om dosen medisin kunne økes i de neste kohortene av pasienter.
Arm 1, Phase 1 og Phase 2:
After a planned review of the interim safety data from the Phase 1 and 2 parts of Arm 1 of Lymrit 37-01, based on 15 patients with relapsed/refractory FL treated with 15 MBq/kg Betalutin® and pre-dosed with 40 mg lilotomab*, the SRC concluded the following:
• The regimen of 15 MBq/kg Betalutin® administered after pre-dosing with 40 mg lilotomab is safe and the safety profile observed to date supports a possible dose escalation of Betalutin®
• The efficacy profile is promising compared to other candidates in development, particularly with regard to complete responses
Arm 4:
• The limited safety data available to date from the first cohort of three patients in Arm 4 (receiving 15 MBq/kg Betalutin® and pre-dosed with 100mg/m2 lilotomab**) is encouraging and appears to show that an increase in pre-dosing with lilotomab improves the safety profile of Betalutin®
• Safety and dosimetry data from Arm 4 should confirm if and to what level the doses of Betalutin® and lilotomab in Phase 2 can be increased to further improve the risk/benefit profile seen so far.
http://www.nordicnanovector.com/article/Safety-Review-Committee-supports-dose-escalation-with-Betalutin-in-Lymrit-37-01-trial-pending-safety-data-from-cohort-receiving-higher-pre-dosing/2312101
http://www.nordicnanovector.com/article/Safety-Review-Committee-for-Nordic-Nanovectors-Lymrit-37-01-trial-recommends-dose-escalation-to-20-MBq-kg-with-Betalutin/2353331