Genmab Announces Preliminary Safety and Efficacy Data for Daratumumab
- Preliminary Phase I/II data show daratumumab is active in multiple myeloma & has an acceptable safety profile
- Data presented in poster session today at the ASH Annual Meeting
Copenhagen, Denmark; December 11, 2011 - Genmab A/S (OMX: GEN) announced today encouraging preliminary safety and efficacy data from the first Phase I/II clinical study of daratumumab (HuMax®-CD38) in multiple myeloma. A 49%, 55%, and 61% reduction in the serum M-component was observed in the three patients treated at the highest dose level examined so far (4 mg/kg of daratumumab). The serum M-component is an abnormal protein produced by the cancerous plasma cells and is a direct marker for tumor activity. Reduction in the serum M-component is a key factor for response evaluations in multiple myeloma. The observed level of reduction therefore indicates that daratumumab was clinically active in these multiple myeloma patients.
The data presented today was from 23 patients who received daratumumab in doses up to 4mg/kg. The data also showed daratumumab has an acceptable safety profile. The most common adverse events seen in the study so far were pyrexia, cough, free hemoglobin, anemia, dizziness, hemolysis, flu-like illness, nausea, lymphopenia and monocytopenia.
"We are delighted to share these preliminary data which offer the first insight we have into the activity of daratumumab in multiple myeloma. We have not yet reached the maximum tolerated dose and therefore the study will continue to examine patients at higher doses and we look forward to announcing detailed safety and response data at a later date," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Det ser meget Lovende ud faktisk, men det er stadig meget early stage. Resulaterne må være stærke nok til at en del partnere vil stå på spring for at komme med om bord og for Genmab handler det om at få en partner ind på så tidligt et stadie som muligt, sådan at Jans ide om klinikken som cashgenerator istedet for cashburner også kan blive enrealitet
- Preliminary Phase I/II data show daratumumab is active in multiple myeloma & has an acceptable safety profile
- Data presented in poster session today at the ASH Annual Meeting
Copenhagen, Denmark; December 11, 2011 - Genmab A/S (OMX: GEN) announced today encouraging preliminary safety and efficacy data from the first Phase I/II clinical study of daratumumab (HuMax®-CD38) in multiple myeloma. A 49%, 55%, and 61% reduction in the serum M-component was observed in the three patients treated at the highest dose level examined so far (4 mg/kg of daratumumab). The serum M-component is an abnormal protein produced by the cancerous plasma cells and is a direct marker for tumor activity. Reduction in the serum M-component is a key factor for response evaluations in multiple myeloma. The observed level of reduction therefore indicates that daratumumab was clinically active in these multiple myeloma patients.
The data presented today was from 23 patients who received daratumumab in doses up to 4mg/kg. The data also showed daratumumab has an acceptable safety profile. The most common adverse events seen in the study so far were pyrexia, cough, free hemoglobin, anemia, dizziness, hemolysis, flu-like illness, nausea, lymphopenia and monocytopenia.
"We are delighted to share these preliminary data which offer the first insight we have into the activity of daratumumab in multiple myeloma. We have not yet reached the maximum tolerated dose and therefore the study will continue to examine patients at higher doses and we look forward to announcing detailed safety and response data at a later date," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Det ser meget Lovende ud faktisk, men det er stadig meget early stage. Resulaterne må være stærke nok til at en del partnere vil stå på spring for at komme med om bord og for Genmab handler det om at få en partner ind på så tidligt et stadie som muligt, sådan at Jans ide om klinikken som cashgenerator istedet for cashburner også kan blive enrealitet
GEN501_ASH_2011_poster_final.pdf Det her er jo meget early stage resultater, og det ved vi nu også er helt centralt for en god aftale, at der kan indgåes en aftale så tidligt som muligt.
Her er formålet med forsøget.
Primary objective:
• Establishment of the safety profile of daratumumab when given as monotherapy in patients with MM relapsed or refractory to at least two different prior therapies.
Secondary objectives include:
• Establishment of maximal tolerated dose (MTD) for future studies with daratumumab.
• Evaluation of efficacy of daratumumab when given as monotherapy in patients with MM.
Her er formålet med forsøget.
Primary objective:
• Establishment of the safety profile of daratumumab when given as monotherapy in patients with MM relapsed or refractory to at least two different prior therapies.
Secondary objectives include:
• Establishment of maximal tolerated dose (MTD) for future studies with daratumumab.
• Evaluation of efficacy of daratumumab when given as monotherapy in patients with MM.
11/12 2011 13:38 JKY_VH 0
49694 Aka, ser du nogen muligheder for, at denne nyhed også kan have en positiv afsmitning på Genmab?
http://www.news-medical.net/news/20111208/Positive-results-from-Genentechs-pertuzumab-plus-Herceptin-Phase-III-study-on-HER2-positive-mBC.aspx
http://www.news-medical.net/news/20111208/Positive-results-from-Genentechs-pertuzumab-plus-Herceptin-Phase-III-study-on-HER2-positive-mBC.aspx
11/12 2011 15:25 gentogen 049703 Ja, det er jo meget foreløbigt, men i øvrigt er de anførte resultater for de tre patienter i den foreløbige maks. gruppe på et niveau, der er almindeligt anerkendt som PR, så det er vist udmærket. Selv om det vel er lidt skuffende, at de ikke er nået længere. I øvrigt har Genmab så vidt jeg kan se slettet (aflyst ?) arrangementet i London d. 19. december(?).Det havde jeg ellers set lidt frem til, da der som bekendt er en hel stribe endog særdeles gode (i mine øjne super gode) arzerra resultater på ASH, som Genmab foreløbig slet ikke har kommenteret på.
12/12 2011 00:52 MadsSkjern 049718 Post-ash seminar den 19.dec står fortsat i Event-kalenderen på Genmabs hjemmeside.
Dara studiet er på "patients with multiple myeloma that is relapsed or refractory to at least two different prior treatments" = Svært syge patienter. Jeg synes det tyder godt!
Dara studiet er på "patients with multiple myeloma that is relapsed or refractory to at least two different prior treatments" = Svært syge patienter. Jeg synes det tyder godt!
Hej JKY,
Sådan grundlæggende, jo flere der får Rituximab, jo flere bliver refrac -altså respondere på behandlingen.
Det har alt sammen en indvirkning på salget, men helt umuligt at overskue den konkrete afsmitning på Arzerra salget.
Indtil videre venter vi på at Arzerra skal få lidt mere offlabel salg og selve dynamikken i det bør kunne drives (måske) af weekendens ASH konference. Men vi skal i så i givet fald ser det om 2 kvartaler.
Hvad skal man mene om Genmab. Stoffet er på markedet og sælger i indikationen mere end selv de mest positive analytikere havde forudset. Men det er ikke nok fra et investorperspektiv. Vi skal se noget mersalg fra disse forskellige informationer uden om.
Så nej. Lige pt. ser jeg ikke nogen positiv afsmitning på eksterne faktorer. Det handler ene og alene om salg.
Sådan grundlæggende, jo flere der får Rituximab, jo flere bliver refrac -altså respondere på behandlingen.
Det har alt sammen en indvirkning på salget, men helt umuligt at overskue den konkrete afsmitning på Arzerra salget.
Indtil videre venter vi på at Arzerra skal få lidt mere offlabel salg og selve dynamikken i det bør kunne drives (måske) af weekendens ASH konference. Men vi skal i så i givet fald ser det om 2 kvartaler.
Hvad skal man mene om Genmab. Stoffet er på markedet og sælger i indikationen mere end selv de mest positive analytikere havde forudset. Men det er ikke nok fra et investorperspektiv. Vi skal se noget mersalg fra disse forskellige informationer uden om.
Så nej. Lige pt. ser jeg ikke nogen positiv afsmitning på eksterne faktorer. Det handler ene og alene om salg.
Ja, og nu er begivenheden i London også opdateret med beskeden: The seminar will take place from 14.30-17 GMT and will be webcast on Genmab's website
13/12 2011 10:28 Sukkeralf 049771 Glæder mig til lidt uddybning af Daratumumab data - nogen der har kigget mere på det ?
Mvh
Sukkeralf
Mvh
Sukkeralf
