Til Solsen eller Mads Skjern: Ka´ i huske den famøse tirsdag i AUG 2009,, da det hele ramlede for GENMAB,, det var så vidt jeg husker nogle rigtige dårlige resultater med Azerra ifb. med NHL,, er man stadig igang med nye forsøg for at gøre procenterne bedre,, jeg fornemmer udfra det i skriver,, at der er kommet nye tal,, der gør at der er sket en stigning,, eller er er det noget jeg har drømt -:),, hvad mener i iøvrigt,, er der forhåbninger om at Azzerra kan bli godkendt til NHL eller er det løb kørt ???
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Sendt fra ProInvestor gruppen
3/4 2012 16:09 celsius 0
55168 Hvis der andre der svare på ovenstående indlæg er i selvfølgelig meget velkommen til det -:) mon ikke også Gentogen & Aka ville ku´ha´en kommentar til det -:) -:)
Det afhænger lidt af den nøjagtige definition. Genmab har tre fase III studier i NHL (FL og DLBCL). Plus diverse andet.
Men ja. Det er ganske rigtigt umuligt at glemme for Genmab aktionærer. Studiet var i rituximab refraktær follikulær non-Hodgkin's (NHL) (meget, meget, meget syge patienter).
Interessant nok kom der en måneds tid senere samme år et studie i ubehandlet NHL, som var temmelig godt:
"The overall response rate (ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu."
Se også denne nye artikel:
Br J Haematol. 2012 Mar 13. doi: 10.1111/j.1365-2141.2012.09086.x. [Epub ahead of print]
Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma.
Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; for the 409 Study Investigators.
Source
Roswell Park Cancer Institute, Buffalo, NY, USA.
Abstract
An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD20 monoclonal antibody, combined with cyclophosphamide (750 mg/m(2) ), doxorubicin (50 mg/m(2) ), prednisone (100 mg days 3-7) and vincristine (1•4 mg/m(2) ) (O-CHOP), as frontline treatment for follicular lymphoma (FL). 59 patients with previously untreated FL were randomized to ofatumumab 500 mg (n = 29) or 1000 mg (n = 30) day 1, with CHOP on day 3 every 3 weeks for six cycles. Median duration of FL was 0•1 years for both dose groups; 34% and 38% of patients had high-risk Follicular Lymphoma International Prognostic Index (FLIPI) scores in the 500- and 1000-mg dose groups, respectively. Overall response rate was 90% for the 500-mg group and 100% for the 1000-mg group. 62% of patients achieved complete response (CR)/unconfirmed CR (CRu). 76% of patients with FLIPI score 3-5 attained CR/CRu. Longer follow-up time is needed for analysis of survival end points. The most common Common Terminology Criteria grade 3-4 investigator-reported adverse events were leucopenia (29%) and neutropenia (22%). No deaths have been reported. O-CHOP was safe and efficacious in patients with previously untreated FL, including high-risk FLIPI groups. This trial was registered at www.clinicaltrials.gov (NCT00494780).
© 2012 Blackwell Publishing Ltd.
Jeg gentager: 62 % CR...
Så jo: Der arbejdes på sagen.
Men ja. Det er ganske rigtigt umuligt at glemme for Genmab aktionærer. Studiet var i rituximab refraktær follikulær non-Hodgkin's (NHL) (meget, meget, meget syge patienter).
Interessant nok kom der en måneds tid senere samme år et studie i ubehandlet NHL, som var temmelig godt:
"The overall response rate (ORR) in patients treated with 500 mg of ofatumumab (n=29) was 90%, including 24% complete remissions (CR), and 45% complete remissions/unconfirmed (CRu). In patients treated with 1000 mg of ofatumumab (n=29), the ORR was 100% including 38% CR, and 17% CRu."
Se også denne nye artikel:
Br J Haematol. 2012 Mar 13. doi: 10.1111/j.1365-2141.2012.09086.x. [Epub ahead of print]
Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma.
Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; for the 409 Study Investigators.
Source
Roswell Park Cancer Institute, Buffalo, NY, USA.
Abstract
An international, Phase II trial was conducted to assess two doses of ofatumumab, a human CD20 monoclonal antibody, combined with cyclophosphamide (750 mg/m(2) ), doxorubicin (50 mg/m(2) ), prednisone (100 mg days 3-7) and vincristine (1•4 mg/m(2) ) (O-CHOP), as frontline treatment for follicular lymphoma (FL). 59 patients with previously untreated FL were randomized to ofatumumab 500 mg (n = 29) or 1000 mg (n = 30) day 1, with CHOP on day 3 every 3 weeks for six cycles. Median duration of FL was 0•1 years for both dose groups; 34% and 38% of patients had high-risk Follicular Lymphoma International Prognostic Index (FLIPI) scores in the 500- and 1000-mg dose groups, respectively. Overall response rate was 90% for the 500-mg group and 100% for the 1000-mg group. 62% of patients achieved complete response (CR)/unconfirmed CR (CRu). 76% of patients with FLIPI score 3-5 attained CR/CRu. Longer follow-up time is needed for analysis of survival end points. The most common Common Terminology Criteria grade 3-4 investigator-reported adverse events were leucopenia (29%) and neutropenia (22%). No deaths have been reported. O-CHOP was safe and efficacious in patients with previously untreated FL, including high-risk FLIPI groups. This trial was registered at www.clinicaltrials.gov (NCT00494780).
© 2012 Blackwell Publishing Ltd.
Jeg gentager: 62 % CR...
Så jo: Der arbejdes på sagen.
4/4 2012 08:06 investor1989 155179 62 % CR - Ja det er jo også en størrelse:
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http://www.businesswire.com/news/home/20111212005616/en/Impressive-ZEVALIN%C2%AE-Data-Highlighted-53rd-Annual-Meeting
Jeg kan nu bedre lide 82% mod untreated FL patienter :) Best of ASH 2011 og allerede godkendt på markedet :)Seriøst konkurrence tror jeg.
-----------------
http://www.businesswire.com/news/home/20111212005616/en/Impressive-ZEVALIN%C2%AE-Data-Highlighted-53rd-Annual-Meeting
Jeg kan nu bedre lide 82% mod untreated FL patienter :) Best of ASH 2011 og allerede godkendt på markedet :)Seriøst konkurrence tror jeg.
4/4 2012 08:11 investor1989 055180 the complete (CR+CRu) and partial response rates were 87% and 13%. With RIT consolidation, the CR rate increased to 91%.
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Results: The ORR was 93% (45/48) with a CR rate of 82% (41/48).
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Results: The ORR was 93% (45/48) with a CR rate of 82% (41/48).
------------------------
Og her lige lidt data i DLBLC:
http://www.marketwatch.com/story/zevalin-plus-high-dose-chemotherapy-z-beam-highly-effective-in-aggressive-lymphoma-randomized-study-published-in-cancer-the-journal-of-the-american-cancer-society-2012-01-23
Så kan alle jer Genman nørder vurdere om der er en reel konkurrence eller ej :)
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Results: The ORR was 93% (45/48) with a CR rate of 82% (41/48).
-----------------------
Results: The ORR was 93% (45/48) with a CR rate of 82% (41/48).
------------------------
Og her lige lidt data i DLBLC:
http://www.marketwatch.com/story/zevalin-plus-high-dose-chemotherapy-z-beam-highly-effective-in-aggressive-lymphoma-randomized-study-published-in-cancer-the-journal-of-the-american-cancer-society-2012-01-23
Så kan alle jer Genman nørder vurdere om der er en reel konkurrence eller ej :)
4/4 2012 09:29 gentogen 055183 Der er naturligvis seriøse konkurrenter.Det gælder for alt, hvad Genmab laver. Det er også derfor Ofatumumab er H2H mod Rituximab, der så vidt jeg ved netop er en del af behandlingsforløbet i de omtalte konkurrerende forsøg. Kombinationsbehandlinger er som bekendt særdeles udbredte. Det ene produkt behøver ikke at udelukke det andet. På lignende vis er det en pointe for Genmabs Daratumumab, at Genmab har opdaget nogle tilsyneladende helt særlige synergieffekter med andre stoffer.
4/4 2012 10:41 investor1989 055185 Jeps. Zevalin er tænkt som kombination mod FL med Rituxan som RRZ behandling. Nok derfor Spectrum er igang med at udvikle biosimilar af Rituxan så kan de selv få indtægterne fra RR :)
Måske i fremtiden vi får AAZ behandling med dobbelt arzerra. Fremtiden er åben :)
Måske i fremtiden vi får AAZ behandling med dobbelt arzerra. Fremtiden er åben :)
Abstract
Ofatumumab is a fully human anti-CD20 monoclonal antibody in phase II-III trials for various autoimmune and lymphoreticular diseases. We used it to treat a rituximab-allergic child with severe, chronic-relapsing, opsoclonus-myoclonus syndrome (OMS), characterized by persistent cerebrospinal fluid (CSF) B-cell expansion and T-cell dysregulation. He had relapsed despite chemotherapy, plasma exchange with immunoadsorption, and resection of ganglioneuroblastoma, detected 3 years after OMS onset. The four ofatumumab infusions (1,195 mg/m2 total dose) were well tolerated, and CSF B-cell expansion was eliminated. No further relapses have occurred in 3 years, but he remains on low-dose ACTH with neuropsychiatric residuals of OMS. Pediatr Blood Cancer 2012; 58: 988-991. © 2011 Wiley Periodicals, Inc.
Ofatumumab is a fully human anti-CD20 monoclonal antibody in phase II-III trials for various autoimmune and lymphoreticular diseases. We used it to treat a rituximab-allergic child with severe, chronic-relapsing, opsoclonus-myoclonus syndrome (OMS), characterized by persistent cerebrospinal fluid (CSF) B-cell expansion and T-cell dysregulation. He had relapsed despite chemotherapy, plasma exchange with immunoadsorption, and resection of ganglioneuroblastoma, detected 3 years after OMS onset. The four ofatumumab infusions (1,195 mg/m2 total dose) were well tolerated, and CSF B-cell expansion was eliminated. No further relapses have occurred in 3 years, but he remains on low-dose ACTH with neuropsychiatric residuals of OMS. Pediatr Blood Cancer 2012; 58: 988-991. © 2011 Wiley Periodicals, Inc.
