PATIENTREKRUTTERING AFSLUTTET TIL FASE II STUDIE MED
ARZERRA™ (OFATUMUMAB) TIL BEHANDLING AF
RECIDIVERENDE DLBCL
Resumé: Rekrutteringen af patienter til fase II studiet med Arzerra (ofatumumab) til behandling
af recidiverende DLBCL er afsluttet.
København, Danmark, 24. juli 2009 – Genmab A/S (OMX: GEN) har i dag meddelt, at
selskabet har afsluttet rekrutteringen af 75 patienter til fase II undersøgelsen med Arzerra™
(ofatumumab) til evaluering af behandling af recidiverende diffust storcellet B-celle lymfom
(DLBCL) hos patienter, som ikke kan tåle, eller som har fået tilbagefald efter
stamcelletransplantation.
Om undersøgelsen
I denne ublindede undersøgelse får hver patient 8 ugentlige infusioner med ofatumumab. Den
første infusion vil være på 300 mg, og de 7 næste infusioner vil være på 1000 mg ofatumumab.
Sygdomsstatus vil blive vurderet 4 uger efter den sidste infusion og derefter hver 3. måned op til
i alt 24 måneder efter behandlingsstart. Efter 24 måneder vil patienterne blive fulgt indtil
igangsættelsen af alternativ behandling mod DLBCL eller frem til måned 60.
Undersøgelsens formål er at fastlægge effekten af ofatumumab hos patienter med tilbagefald af
DLBCL, som er uegnede til transplantation, eller som har fået tilbagefald efter transplantation.
Undersøgelsens primære endpoint er objektivt respons over en 6-måneders periode fra
behandlingens start.
Om ofatumumab
Ofatumumab er et nyt fuldt humant monoklonalt antistof under udvikling, som retter sig mod en
epitop (et specifikt bindingssted) på CD20-molekylet i det lille ekstracellulære domæne, som
ligger tæt på overfladen af B-cellerne. Denne epitop er forskellig fra de bindingssteder, som de
øvrige CD20-antistoffer, der i øjeblikket er tilgængelige, retter sig imod.
Ofatumumab udvikles i henhold til en aftale om fælles udvikling og kommercialisering mellem
Genmab og GlaxoSmithKline. Ofatumumab er endnu ikke godkendt i noget land.
ARZERRA™ (OFATUMUMAB) TIL BEHANDLING AF
RECIDIVERENDE DLBCL
Resumé: Rekrutteringen af patienter til fase II studiet med Arzerra (ofatumumab) til behandling
af recidiverende DLBCL er afsluttet.
København, Danmark, 24. juli 2009 – Genmab A/S (OMX: GEN) har i dag meddelt, at
selskabet har afsluttet rekrutteringen af 75 patienter til fase II undersøgelsen med Arzerra™
(ofatumumab) til evaluering af behandling af recidiverende diffust storcellet B-celle lymfom
(DLBCL) hos patienter, som ikke kan tåle, eller som har fået tilbagefald efter
stamcelletransplantation.
Om undersøgelsen
I denne ublindede undersøgelse får hver patient 8 ugentlige infusioner med ofatumumab. Den
første infusion vil være på 300 mg, og de 7 næste infusioner vil være på 1000 mg ofatumumab.
Sygdomsstatus vil blive vurderet 4 uger efter den sidste infusion og derefter hver 3. måned op til
i alt 24 måneder efter behandlingsstart. Efter 24 måneder vil patienterne blive fulgt indtil
igangsættelsen af alternativ behandling mod DLBCL eller frem til måned 60.
Undersøgelsens formål er at fastlægge effekten af ofatumumab hos patienter med tilbagefald af
DLBCL, som er uegnede til transplantation, eller som har fået tilbagefald efter transplantation.
Undersøgelsens primære endpoint er objektivt respons over en 6-måneders periode fra
behandlingens start.
Om ofatumumab
Ofatumumab er et nyt fuldt humant monoklonalt antistof under udvikling, som retter sig mod en
epitop (et specifikt bindingssted) på CD20-molekylet i det lille ekstracellulære domæne, som
ligger tæt på overfladen af B-cellerne. Denne epitop er forskellig fra de bindingssteder, som de
øvrige CD20-antistoffer, der i øjeblikket er tilgængelige, retter sig imod.
Ofatumumab udvikles i henhold til en aftale om fælles udvikling og kommercialisering mellem
Genmab og GlaxoSmithKline. Ofatumumab er endnu ikke godkendt i noget land.
24/7 2009 19:31 RTH 0
15736 mange tak for info Aka 
et andet spm.: jeg bruger pt. Euroinvestor med realtid og må indrømme, at jeg efterhånden er meget træt af langsom eller endog manglende opdatering. Er der et andet og bedre alternativ, du kan anbefale?
et andet spm.: jeg bruger pt. Euroinvestor med realtid og må indrømme, at jeg efterhånden er meget træt af langsom eller endog manglende opdatering. Er der et andet og bedre alternativ, du kan anbefale?24/7 2009 19:34 JørgenVarnæs 015737 Jeg kan kun anbefale Nordnet - du skal dog have et depot hos dem, men de er ganske konkurrencedygtige på kurtagen. Og så har du oven i købet adgang til nyhederne, når de kommer.
24/7 2009 20:37 JørgenVarnæs 015739 Der var lige denne nyhed, der røg under radaren:
http://borsen.dk/investor/nyhed/162300/
Check lige dette afsnit:
...citat
Endnu værre gik det for det tyske medicinalselskab Merck KGaA, som faldt 14,7 pct., efter de europæiske lægemiddelmyndigheder afviste en ansøgning vedrørende selskabets produkt Erbitux til brug mod lungekræft. Produktet var forventet at indbringe en europæisk omsætning på 252 mio. euro i 2015 i denne indikation, ifølge Bloomberg News.
...citat slut
Er det ikke interessant?
http://borsen.dk/investor/nyhed/162300/
Check lige dette afsnit:
...citat
Endnu værre gik det for det tyske medicinalselskab Merck KGaA, som faldt 14,7 pct., efter de europæiske lægemiddelmyndigheder afviste en ansøgning vedrørende selskabets produkt Erbitux til brug mod lungekræft. Produktet var forventet at indbringe en europæisk omsætning på 252 mio. euro i 2015 i denne indikation, ifølge Bloomberg News.
...citat slut
Er det ikke interessant?
24/7 2009 20:56 tumult 015740 Så må Genmab igang med lungekræft.
Hvad mon begrundelsen var for ikke at godkende. ?
Hvad mon begrundelsen var for ikke at godkende. ?
24/7 2009 21:23 Solsen 015742 Det har de prøvet - men afbrød grundet at en del patienter slet ikke responderer på egfr pga en mutation !
De vender måske tilbage med et nyt forsøgsdesign, hvor disse mutanter ikke kan deltage.
De vender måske tilbage med et nyt forsøgsdesign, hvor disse mutanter ikke kan deltage.
25/7 2009 00:43 Solsen 015744 Iressa and Erbitux Compared in Lung Cancer 8/16/05
In an comparison study of Iressa (gefitinib) and Erbitux (cetuximab) in non-small cell lung cancer (NSCLC), researchers from the Dana-Farber Cancer Institute, Boston, found that while both drugs killed cells containing a normal but overactive epidermal growth factor receptor (EGFR) molecule, only Iressa had an effect on cells carrying the mutant EGFR protein. The monoclonal antibody drug Erbitux was not effective on those cells.
“The question we were faced with after the identification of EGFR mutations was, do all drugs act the same way on the mutant receptor?” says Pasi Jänne, MD, PhD, assistant professor of medicine, Dana-Farber, and senior author of the study, published this week in the Journal of the National Cancer Institute [Mukohara, et al., vol. 97, pp. 1185-1194 (2005)].
Last year, Jänne’s group contributed to the research that identified the mutations as being very important in patients with lung cancer and being predictors of clinical and radiographic benefits to patients for those receiving the EGFR tyrosine kinase inhibitors, Iressa and Tarceva (erlotinib).
With all of the different ways to inhibit EGFR, Jänne’s group then wondered about using an antibody that is directed at the extracellular domain and if that would be effective in an EGFR mutant.
To determine whether Erbitux might be another option for NSCLC patients who carry the EGFR mutation, they treated lung cancer cell lines with Iressa and Erbitux. Both drugs blocked the excess signals in cells with normal EGFR, but only Iressa was significantly effective in those carrying a mutant EGFR.
“The information we generated from the cell lines suggest that only the tyrosine kinase inhibitors are going to be effective,” says Jänne.
They then were able to generate some information from a limited number of patients who received both therapies sequentially. These patients all had an EGFR mutation and they all received either the Erbitux first followed by Iressa, or vice versa. All of them seemed to respond to the Iressa but none of them responded to the Erbitux, Jänne says. “If you have an EGFR mutation, the best way to inhibit it is with the tyrosine kinase inhibitor and antibodies are not going to be very effective, based on our information.”
Erbitux is a monoclonal antibody drug that binds to a portion of the EGFR receptor that extends outside the cell. The researchers say that this difference in action may explain the lack of effect against the mutant EGFR cells.
Erbitux is effectively used in colon cancer, Jänne says, which is not as associated with mutations of EGFR. “What our study does not answer is why the antibody works in some colon cancers and in some lung cancers. All our study suggests is that it is not the mutation that is the predictor for sensitivity as it is for the small molecule inhibitors.”
The researchers benefited from being able to study not just the cell lines, but the patient data as well, where they found the same correlation. “The patient data strengthens the finding from the in vitro study,” says Jänne.
He says they would like to study more patients who have received these drugs to uncover the determinants for drug efficacy or how to choose patients that would respond to the antibody.
“You can envision that, using molecular approaches, we can choose a population of patients to offer the small molecule inhibitor. You may also be able to choose another population of patients that is most likely to respond to the antibody. As we learn more about the importance of these genetic alterations and EGFR, we will be able to do that in future studies.”
By Elizabeth Tolchin
http://www.biosciencetechnology.com/ShowPR.aspx?PUBCODE=090&ACCT=9000000100&ISSUE=0508&RELTYPE=PR&ORIGRELTYPE=RLSN&PRODCODE=00000000&PRODLETT=M&CommonCount=0
In an comparison study of Iressa (gefitinib) and Erbitux (cetuximab) in non-small cell lung cancer (NSCLC), researchers from the Dana-Farber Cancer Institute, Boston, found that while both drugs killed cells containing a normal but overactive epidermal growth factor receptor (EGFR) molecule, only Iressa had an effect on cells carrying the mutant EGFR protein. The monoclonal antibody drug Erbitux was not effective on those cells.
“The question we were faced with after the identification of EGFR mutations was, do all drugs act the same way on the mutant receptor?” says Pasi Jänne, MD, PhD, assistant professor of medicine, Dana-Farber, and senior author of the study, published this week in the Journal of the National Cancer Institute [Mukohara, et al., vol. 97, pp. 1185-1194 (2005)].
Last year, Jänne’s group contributed to the research that identified the mutations as being very important in patients with lung cancer and being predictors of clinical and radiographic benefits to patients for those receiving the EGFR tyrosine kinase inhibitors, Iressa and Tarceva (erlotinib).
With all of the different ways to inhibit EGFR, Jänne’s group then wondered about using an antibody that is directed at the extracellular domain and if that would be effective in an EGFR mutant.
To determine whether Erbitux might be another option for NSCLC patients who carry the EGFR mutation, they treated lung cancer cell lines with Iressa and Erbitux. Both drugs blocked the excess signals in cells with normal EGFR, but only Iressa was significantly effective in those carrying a mutant EGFR.
“The information we generated from the cell lines suggest that only the tyrosine kinase inhibitors are going to be effective,” says Jänne.
They then were able to generate some information from a limited number of patients who received both therapies sequentially. These patients all had an EGFR mutation and they all received either the Erbitux first followed by Iressa, or vice versa. All of them seemed to respond to the Iressa but none of them responded to the Erbitux, Jänne says. “If you have an EGFR mutation, the best way to inhibit it is with the tyrosine kinase inhibitor and antibodies are not going to be very effective, based on our information.”
Erbitux is a monoclonal antibody drug that binds to a portion of the EGFR receptor that extends outside the cell. The researchers say that this difference in action may explain the lack of effect against the mutant EGFR cells.
Erbitux is effectively used in colon cancer, Jänne says, which is not as associated with mutations of EGFR. “What our study does not answer is why the antibody works in some colon cancers and in some lung cancers. All our study suggests is that it is not the mutation that is the predictor for sensitivity as it is for the small molecule inhibitors.”
The researchers benefited from being able to study not just the cell lines, but the patient data as well, where they found the same correlation. “The patient data strengthens the finding from the in vitro study,” says Jänne.
He says they would like to study more patients who have received these drugs to uncover the determinants for drug efficacy or how to choose patients that would respond to the antibody.
“You can envision that, using molecular approaches, we can choose a population of patients to offer the small molecule inhibitor. You may also be able to choose another population of patients that is most likely to respond to the antibody. As we learn more about the importance of these genetic alterations and EGFR, we will be able to do that in future studies.”
By Elizabeth Tolchin
http://www.biosciencetechnology.com/ShowPR.aspx?PUBCODE=090&ACCT=9000000100&ISSUE=0508&RELTYPE=PR&ORIGRELTYPE=RLSN&PRODCODE=00000000&PRODLETT=M&CommonCount=0
