Dette er strengt taget ikke nogen nyhed, men jeg kan ikke mindes, at disse resultater har været omtalt her før.Skulle jeg huske galt, så beklager jeg naturligvis...., men det ser jo under alle omstændigheder ret fornuftigt ud.....
Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 28, No 15_suppl (May 20 Supplement), 2010: 8042
© 2010 American Society of Clinical Oncology
Ofatumumab combined with CHOP in previously untreated patients with follicular lymphoma (FL).
M. S. Czuczman, A. Viardot, G. Hess, O. V. Gadeberg, L. M. Pedersen, I. Gupta, T. S. Lin, C. Strange, K. Windfeld and C. A. Russell
Roswell Park Cancer Institute, Buffalo, NY; Universitätsklinikum Ulm, Ulm, Germany; Universitätsmedizin Mainz, Mainz, Germany; Vejle Hospital, Vejle, Denmark; Odense University Hospital, Odense, Denmark; GlaxoSmithKline, Collegeville, PA; The Ohio State University, Columbus, OH; Genmab, Copenhagen, Denmark
Abstract
8042^
Background: Ofatumumab (OFA) is a human antibody that targets a membrane-proximal epitope encompassing the small- and large-loop on CD20. Single-agent OFA has demonstrated clinical activity in relapsed/refractory FL at doses up to 1,000 mg. We report results from a phase II trial of OFA with CHOP (O-CHOP) in patients (pts) with FL.
Methods: The planned sample size was N=56; 59 pts with previously untreated CD20+ FL (Grade 1–3, stage III–IV or bulky stage II) were randomized to OFA Day 1,500 mg (Group A) or 1,000 mg (Group B); cyclophosphamide Day 3, 750 mg/m2; doxorubicin Day 3, 50 mg/m2; vincristine Day 3, 1.4 mg/m2; and prednisolone Days 3–7, 100 mg every 3 weeks for 6 cycles. First OFA dose was 300 mg for both groups. One pt withdrew before treatment and was excluded from analysis. Primary endpoint was overall response rate (ORR; 1999 International Working Group criteria) assessed by an Independent Endpoint Review Committee.
Results: 29 pts were enrolled into each group; 93 and 100% of pts in Groups A and B, respectively, received all 6 cycles of therapy. Baseline characteristics for Group A / Group B were: median age, 55 / 54 years; FLIPI score 3–5, 34% / 38% of pts. ORR (95% CI) was 90% (73, 98%) in Group A and 100% (88, 100%) in Group B. Complete response (CR) + unconfirmed CR (CRu) was 69% in Group A and 55% in Group B. Overall, 16 of 21 pts (76%) with FLIPI score 3–5 attained CR/CRu. Median follow-up was 9.7 months. OFA infusion-related reactions were primarily grade 1–2 and decreased in incidence with continued therapy; 2 pts (Group B) had grade 3 reactions during first dose, but were able to receive subsequent doses. The most common investigator-reported grade 3–4 adverse events were leukopenia and neutropenia (31 and 28%, Group A; 28 and 17%, Group B). Incidences of grade 3–4 leukopenia and neutropenia by laboratory assessments were 83 and 90% in Group A and 72 and 90% in Group B, respectively. Grade 3–4 infections occurred in 10% of pts in Group A and 3% in Group B, with febrile neutropenia in 7 and 3% of pts, respectively. No deaths have been reported. Additional data will be presented.
Conclusions: O-CHOP achieved high response rates, was effective across all FLIPI risk groups and was well tolerated with no unexpected toxicities in previously untreated FL.
Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 28, No 15_suppl (May 20 Supplement), 2010: 8042
© 2010 American Society of Clinical Oncology
Ofatumumab combined with CHOP in previously untreated patients with follicular lymphoma (FL).
M. S. Czuczman, A. Viardot, G. Hess, O. V. Gadeberg, L. M. Pedersen, I. Gupta, T. S. Lin, C. Strange, K. Windfeld and C. A. Russell
Roswell Park Cancer Institute, Buffalo, NY; Universitätsklinikum Ulm, Ulm, Germany; Universitätsmedizin Mainz, Mainz, Germany; Vejle Hospital, Vejle, Denmark; Odense University Hospital, Odense, Denmark; GlaxoSmithKline, Collegeville, PA; The Ohio State University, Columbus, OH; Genmab, Copenhagen, Denmark
Abstract
8042^
Background: Ofatumumab (OFA) is a human antibody that targets a membrane-proximal epitope encompassing the small- and large-loop on CD20. Single-agent OFA has demonstrated clinical activity in relapsed/refractory FL at doses up to 1,000 mg. We report results from a phase II trial of OFA with CHOP (O-CHOP) in patients (pts) with FL.
Methods: The planned sample size was N=56; 59 pts with previously untreated CD20+ FL (Grade 1–3, stage III–IV or bulky stage II) were randomized to OFA Day 1,500 mg (Group A) or 1,000 mg (Group B); cyclophosphamide Day 3, 750 mg/m2; doxorubicin Day 3, 50 mg/m2; vincristine Day 3, 1.4 mg/m2; and prednisolone Days 3–7, 100 mg every 3 weeks for 6 cycles. First OFA dose was 300 mg for both groups. One pt withdrew before treatment and was excluded from analysis. Primary endpoint was overall response rate (ORR; 1999 International Working Group criteria) assessed by an Independent Endpoint Review Committee.
Results: 29 pts were enrolled into each group; 93 and 100% of pts in Groups A and B, respectively, received all 6 cycles of therapy. Baseline characteristics for Group A / Group B were: median age, 55 / 54 years; FLIPI score 3–5, 34% / 38% of pts. ORR (95% CI) was 90% (73, 98%) in Group A and 100% (88, 100%) in Group B. Complete response (CR) + unconfirmed CR (CRu) was 69% in Group A and 55% in Group B. Overall, 16 of 21 pts (76%) with FLIPI score 3–5 attained CR/CRu. Median follow-up was 9.7 months. OFA infusion-related reactions were primarily grade 1–2 and decreased in incidence with continued therapy; 2 pts (Group B) had grade 3 reactions during first dose, but were able to receive subsequent doses. The most common investigator-reported grade 3–4 adverse events were leukopenia and neutropenia (31 and 28%, Group A; 28 and 17%, Group B). Incidences of grade 3–4 leukopenia and neutropenia by laboratory assessments were 83 and 90% in Group A and 72 and 90% in Group B, respectively. Grade 3–4 infections occurred in 10% of pts in Group A and 3% in Group B, with febrile neutropenia in 7 and 3% of pts, respectively. No deaths have been reported. Additional data will be presented.
Conclusions: O-CHOP achieved high response rates, was effective across all FLIPI risk groups and was well tolerated with no unexpected toxicities in previously untreated FL.
30/11 2010 20:28 1
36686 godt du holder os ajour. som du selv nævner er resultaterne solide, men vi er efterhånden forkældede med gode resultater i fase 1 og 2, så det skal være lægerne der tænder på det, og så kommer i gang i off labet. Disse resultater og specielt bivirkningsprofilen kunne måske få nogen ud i det, og det er dette vi skal se hvis vi skal se et evt. niveauskifte i arzerra salget.
I chatten i går havde vi gang i en kinesisk label og vi var også forbi Dr.Reddy og deres plan om at lancere Ofab i Q1 2011 i indien. Så Asien kan komme op nu, godt nok til en lavere pris, men hvad betyder det hvis omsætningen kommer. GSK har iøvrigt ret godt fat i Asien.
Hvad har vi ellers af datoer inden PI version 5.0?
4-7 dec. ASH (Lægerne)
20. Jan R&D Dag (Institutionelle Investorer)
3. Feb Salgstal Arzerra (opjustering til 60 mill)
7. feb sidste frist for bud på zalutumumab
Hvad kan Jan nå desforinden?
1. salg af fabrik (nok ikke sandsynligt)
2. partnerskab på daratumumab
3. Nye out-of-this-world aftaler ala Lundbeck dealen.
/AKA
I chatten i går havde vi gang i en kinesisk label og vi var også forbi Dr.Reddy og deres plan om at lancere Ofab i Q1 2011 i indien. Så Asien kan komme op nu, godt nok til en lavere pris, men hvad betyder det hvis omsætningen kommer. GSK har iøvrigt ret godt fat i Asien.
Hvad har vi ellers af datoer inden PI version 5.0?
4-7 dec. ASH (Lægerne)
20. Jan R&D Dag (Institutionelle Investorer)
3. Feb Salgstal Arzerra (opjustering til 60 mill)
7. feb sidste frist for bud på zalutumumab
Hvad kan Jan nå desforinden?
1. salg af fabrik (nok ikke sandsynligt)
2. partnerskab på daratumumab
3. Nye out-of-this-world aftaler ala Lundbeck dealen.
/AKA
