Difference between revisions of "Cold agglutinin disease"
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(Sutimlimab regimen NEJM 2021) |
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{| class="wikitable" style="text-align:center; width:50%;" | {| class="wikitable" style="text-align:center; width:50%;" | ||
| − | !colspan="2" align="center" style="color:white; font-size:125%; background-color:#31a354"|'''Section editor''' | + | ! colspan="2" align="center" style="color:white; font-size:125%; background-color:#31a354" |'''Section editor''' |
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| − | |style="background-color:#F0F0F0; width:15%"|[[File:Tillman_Benjamin-2.jpg|frameless|upright=0.3|center]] | + | | style="background-color:#F0F0F0; width:15%" |[[File:Tillman_Benjamin-2.jpg|frameless|upright=0.3|center]] |
| − | |style="width:35%"|<big>[[User:Benjamintillman|Benjamin Tillman, MD]]<br>Vanderbilt University<br>Nashville, TN</big> | + | | style="width:35%" |<big>[[User:Benjamintillman|Benjamin Tillman, MD]]<br>Vanderbilt University<br>Nashville, TN</big> |
|- | |- | ||
|} | |} | ||
| Line 14: | Line 14: | ||
=Guidelines= | =Guidelines= | ||
=="How I Treat"== | =="How I Treat"== | ||
| + | |||
*'''2021:''' Berentsen [https://doi.org/10.1182/blood.2019003809 How I treat cold agglutinin disease] | *'''2021:''' Berentsen [https://doi.org/10.1182/blood.2019003809 How I treat cold agglutinin disease] | ||
| Line 26: | Line 27: | ||
===Regimen {{#subobject:47595c|Variant=1}}=== | ===Regimen {{#subobject:47595c|Variant=1}}=== | ||
{| class="wikitable" style="width: 50%; text-align:center;" | {| class="wikitable" style="width: 50%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
|- | |- | ||
|[http://www.bloodjournal.org/content/130/4/537.long Berentsen et al. 2017] | |[http://www.bloodjournal.org/content/130/4/537.long Berentsen et al. 2017] | ||
| − | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
|- | |- | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Bendamustine]] 90 mg/m<sup>2</sup> IV once per day on days 1 & 2 | *[[Bendamustine]] 90 mg/m<sup>2</sup> IV once per day on days 1 & 2 | ||
| + | |||
====Targeted therapy==== | ====Targeted therapy==== | ||
| + | |||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | ||
| Line 41: | Line 45: | ||
===References=== | ===References=== | ||
| − | # Berentsen S, Randen U, Oksman M, Birgens H, Tvedt THA, Dalgaard J, Galteland E, Haukås E, Brudevold R, Sørbø JH, Næss IA, Malecka A, Tjønnfjord GE. Bendamustine plus rituximab for chronic cold agglutinin disease: results of a Nordic prospective multicenter trial. Blood. 2017 Jul 27;130(4):537-541. Epub 2017 May 22. [http://www.bloodjournal.org/content/130/4/537.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28533306 PubMed] NCT02689986 | + | |
| + | #Berentsen S, Randen U, Oksman M, Birgens H, Tvedt THA, Dalgaard J, Galteland E, Haukås E, Brudevold R, Sørbø JH, Næss IA, Malecka A, Tjønnfjord GE. Bendamustine plus rituximab for chronic cold agglutinin disease: results of a Nordic prospective multicenter trial. Blood. 2017 Jul 27;130(4):537-541. Epub 2017 May 22. [http://www.bloodjournal.org/content/130/4/537.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28533306 PubMed] NCT02689986 | ||
==Eculizumab monotherapy {{#subobject:08ef07|Regimen=1}}== | ==Eculizumab monotherapy {{#subobject:08ef07|Regimen=1}}== | ||
| Line 51: | Line 56: | ||
===Regimen {{#subobject:95a0a9|Variant=1}}=== | ===Regimen {{#subobject:95a0a9|Variant=1}}=== | ||
{| class="wikitable" style="width: 50%; text-align:center;" | {| class="wikitable" style="width: 50%; text-align:center;" | ||
| − | !style="width: 25%"|Study | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
|- | |- | ||
|[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6177646/ Röth et al. 2018 (DECADE)] | |[http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6177646/ Röth et al. 2018 (DECADE)] | ||
| − | |style="background-color:#ffffbe"|Phase II, <20 pts | + | | style="background-color:#ffffbe" |Phase II, <20 pts |
|- | |- | ||
|} | |} | ||
| Line 61: | Line 66: | ||
''Eligible patients had symptomatic cold agglutinin-mediated hemolysis with a serum lactate dehydrogenase (LDH) level greater than or equal to 2 x upper limit of normal and a cold agglutinin titer greater than 1:64 at 4°C.'' | ''Eligible patients had symptomatic cold agglutinin-mediated hemolysis with a serum lactate dehydrogenase (LDH) level greater than or equal to 2 x upper limit of normal and a cold agglutinin titer greater than 1:64 at 4°C.'' | ||
====Immunosuppressive therapy==== | ====Immunosuppressive therapy==== | ||
| + | |||
*[[Eculizumab (Soliris)]] as follows: | *[[Eculizumab (Soliris)]] as follows: | ||
**Cycle 1: 600 mg IV once per day on days 1, 8, 15, 22 | **Cycle 1: 600 mg IV once per day on days 1, 8, 15, 22 | ||
| Line 66: | Line 72: | ||
====Supportive medications==== | ====Supportive medications==== | ||
| − | * Patients were vaccinated against ''Neisseria meningitidis'' or received "appropriate antibiotics" if vaccination occurred within 14 days of the first dose | + | |
| + | *Patients were vaccinated against ''Neisseria meningitidis'' or received "appropriate antibiotics" if vaccination occurred within 14 days of the first dose | ||
'''28-day cycle for 1 cycle, then 14-day cycle for 11 cycles''' | '''28-day cycle for 1 cycle, then 14-day cycle for 11 cycles''' | ||
| Line 72: | Line 79: | ||
===References=== | ===References=== | ||
<!-- # '''Abstract:''' Alexander Röth, MD, Martin Bommer, MD, Andreas Hüttmann, MD, Dörte Herich-Terhürne, Nils Kuklik, PhD, Lenz Veronika, Hubert Schrezenmeier, MD and Ulrich Dührsen, MD. Complement Inhibition with Eculizumab in Patients with Cold Agglutinin Disease (CAD): Results from a Prospective Phase II Trial (DECADE Trial). ASH Annual Meeting 2015 Abstract 274 [https://ash.confex.com/ash/2015/webprogram/Paper79420.html link to abstract] --> | <!-- # '''Abstract:''' Alexander Röth, MD, Martin Bommer, MD, Andreas Hüttmann, MD, Dörte Herich-Terhürne, Nils Kuklik, PhD, Lenz Veronika, Hubert Schrezenmeier, MD and Ulrich Dührsen, MD. Complement Inhibition with Eculizumab in Patients with Cold Agglutinin Disease (CAD): Results from a Prospective Phase II Trial (DECADE Trial). ASH Annual Meeting 2015 Abstract 274 [https://ash.confex.com/ash/2015/webprogram/Paper79420.html link to abstract] --> | ||
| − | # '''DECADE:''' Röth A, Bommer M, Hüttmann A, Herich-Terhürne D, Kuklik N, Rekowski J, Lenz V, Schrezenmeier H, Dührsen U. Eculizumab in cold agglutinin disease (DECADE): an open-label, prospective, bicentric, nonrandomized phase 2 trial. Blood Adv. 2018 Oct 9;2(19):2543-2549. [https://doi.org/10.1182/bloodadvances.2018024190 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6177646/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30291112/ PubMed] NCT01303952 | + | |
| + | #'''DECADE:''' Röth A, Bommer M, Hüttmann A, Herich-Terhürne D, Kuklik N, Rekowski J, Lenz V, Schrezenmeier H, Dührsen U. Eculizumab in cold agglutinin disease (DECADE): an open-label, prospective, bicentric, nonrandomized phase 2 trial. Blood Adv. 2018 Oct 9;2(19):2543-2549. [https://doi.org/10.1182/bloodadvances.2018024190 link to original article] [http://www.ncbi.nlm.nih.gov/pmc/articles/pmc6177646/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30291112/ PubMed] NCT01303952 | ||
==FR {{#subobject:96c221|Regimen=1}}== | ==FR {{#subobject:96c221|Regimen=1}}== | ||
| Line 82: | Line 90: | ||
===Regimen {{#subobject:645885|Variant=1}}=== | ===Regimen {{#subobject:645885|Variant=1}}=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[http://www.bloodjournal.org/content/116/17/3180.long Berentsen et al. 2010] | |[http://www.bloodjournal.org/content/116/17/3180.long Berentsen et al. 2010] | ||
| − | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
| style="background-color:#e0ecf4" |ORR: 76% | | style="background-color:#e0ecf4" |ORR: 76% | ||
|- | |- | ||
| Line 94: | Line 102: | ||
''Eligible patients had to be diagnosed with cold agglutinin disease and require therapy because of anemia, substantial cold-induced circulatory symptoms, or both.'' | ''Eligible patients had to be diagnosed with cold agglutinin disease and require therapy because of anemia, substantial cold-induced circulatory symptoms, or both.'' | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| + | |||
*[[Fludarabine (Fludara)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 5 | *[[Fludarabine (Fludara)]] 40 mg/m<sup>2</sup> PO once per day on days 1 to 5 | ||
| + | |||
====Targeted therapy==== | ====Targeted therapy==== | ||
| + | |||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once on day 1 | ||
| Line 101: | Line 112: | ||
===References=== | ===References=== | ||
| − | # Berentsen S, Randen U, Vågan AM, Hjorth-Hansen H, Vik A, Dalgaard J, Jacobsen EM, Thoresen AS, Beiske K, Tjønnfjord GE. High response rate and durable remissions following fludarabine and rituximab combination therapy for chronic cold agglutinin disease. Blood. 2010 Oct 28;116(17):3180-4. Epub 2010 Jul 15. [http://www.bloodjournal.org/content/116/17/3180.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/20634373 PubMed] NCT00373594 | + | |
| + | #Berentsen S, Randen U, Vågan AM, Hjorth-Hansen H, Vik A, Dalgaard J, Jacobsen EM, Thoresen AS, Beiske K, Tjønnfjord GE. High response rate and durable remissions following fludarabine and rituximab combination therapy for chronic cold agglutinin disease. Blood. 2010 Oct 28;116(17):3180-4. Epub 2010 Jul 15. [http://www.bloodjournal.org/content/116/17/3180.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/20634373 PubMed] NCT00373594 | ||
==Rituximab monotherapy {{#subobject:65c6f1|Regimen=1}}== | ==Rituximab monotherapy {{#subobject:65c6f1|Regimen=1}}== | ||
| Line 111: | Line 123: | ||
===Regimen {{#subobject:372fe5|Variant=1}}=== | ===Regimen {{#subobject:372fe5|Variant=1}}=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[http://www.bloodjournal.org/content/103/8/2925.long Berentsen et al. 2003] | |[http://www.bloodjournal.org/content/103/8/2925.long Berentsen et al. 2003] | ||
| − | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
| style="background-color:#9ebcda" |ORR: 54% | | style="background-color:#9ebcda" |ORR: 54% | ||
|- | |- | ||
|[http://www.tandfonline.com/doi/full/10.1080/10428190500286481 Schöllkopf et al. 2006] | |[http://www.tandfonline.com/doi/full/10.1080/10428190500286481 Schöllkopf et al. 2006] | ||
| − | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
| style="background-color:#8c96c6" |ORR: 45% | | style="background-color:#8c96c6" |ORR: 45% | ||
|- | |- | ||
| Line 127: | Line 139: | ||
''Patients in '''Berentsen et al. 2003''' were required to have cold agglutinin disease, as defined by the combination of chronic hemolysis and a cold agglutinin titer of 1:64 or higher, and a typical pattern for the direct antiglobulin test (DAT).'' | ''Patients in '''Berentsen et al. 2003''' were required to have cold agglutinin disease, as defined by the combination of chronic hemolysis and a cold agglutinin titer of 1:64 or higher, and a typical pattern for the direct antiglobulin test (DAT).'' | ||
====Immunosuppressive therapy==== | ====Immunosuppressive therapy==== | ||
| + | |||
*[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22 | *[[Rituximab (Rituxan)]] 375 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22 | ||
| Line 132: | Line 145: | ||
===References=== | ===References=== | ||
| − | # Berentsen S, Ulvestad E, Gjertsen BT, Hjorth-Hansen H, Langholm R, Knutsen H, Ghanima W, Shammas FV, Tjønnfjord GE. Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients. Blood. 2004 Apr 15;103(8):2925-8. Epub 2003 Dec 30. [http://www.bloodjournal.org/content/103/8/2925.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/15070665 PubMed] | + | |
| − | # Schöllkopf C, Kjeldsen L, Bjerrum OW, Mourits-Andersen HT, Nielsen JL, Christensen BE, Jensen BA, Pedersen BB, Taaning EB, Klausen TW, Birgens H. Rituximab in chronic cold agglutinin disease: a prospective study of 20 patients. Leuk Lymphoma. 2006 Feb;47(2):253-60. [http://www.tandfonline.com/doi/full/10.1080/10428190500286481 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/16321854 PubMed] | + | #Berentsen S, Ulvestad E, Gjertsen BT, Hjorth-Hansen H, Langholm R, Knutsen H, Ghanima W, Shammas FV, Tjønnfjord GE. Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients. Blood. 2004 Apr 15;103(8):2925-8. Epub 2003 Dec 30. [http://www.bloodjournal.org/content/103/8/2925.long link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/15070665 PubMed] |
| + | #Schöllkopf C, Kjeldsen L, Bjerrum OW, Mourits-Andersen HT, Nielsen JL, Christensen BE, Jensen BA, Pedersen BB, Taaning EB, Klausen TW, Birgens H. Rituximab in chronic cold agglutinin disease: a prospective study of 20 patients. Leuk Lymphoma. 2006 Feb;47(2):253-60. [http://www.tandfonline.com/doi/full/10.1080/10428190500286481 link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/16321854 PubMed] | ||
==Sutimlimab monotherapy== | ==Sutimlimab monotherapy== | ||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable" style="width: 75%; text-align:center;" | {| class="wikitable" style="width: 75%; text-align:center;" | ||
| − | !style="width: 33%"|Study | + | ! style="width: 33%" |Study |
| − | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 33%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | + | ! style="width: 33%" |[[Levels_of_Evidence#Efficacy|Efficacy]] |
|- | |- | ||
|[https://www.nejm.org/doi/full/10.1056/NEJMoa2027760?query=oncology-hematology.long Röth et al. 2021] | |[https://www.nejm.org/doi/full/10.1056/NEJMoa2027760?query=oncology-hematology.long Röth et al. 2021] | ||
| − | |style="background-color:#91cf61"|Phase II | + | | style="background-color:#91cf61" |Phase II |
| style="background-color:#9ebcda" |ORR: 54% | | style="background-color:#9ebcda" |ORR: 54% | ||
|- | |- | ||
| + | |||
| + | |} | ||
====Targeted therapy==== | ====Targeted therapy==== | ||
| + | |||
*[[Sutimlimab]] 6.5 g (for patients who weighed less than 75 kg at baseline) and 7.5g (for patients who weighed 75 kg or more) | *[[Sutimlimab]] 6.5 g (for patients who weighed less than 75 kg at baseline) and 7.5g (for patients who weighed 75 kg or more) | ||
| + | |||
'''7 day course for cycle 1 then every 14 days for 26 weeks''' | '''7 day course for cycle 1 then every 14 days for 26 weeks''' | ||
Revision as of 04:38, 8 May 2021
| Section editor | |
|---|---|
 |
Benjamin Tillman, MD Vanderbilt University Nashville, TN |
4 regimens on this page
4 variants on this page
|
Guidelines
"How I Treat"
- 2021: Berentsen How I treat cold agglutinin disease
All lines of therapy
Bendamustine & Rituximab (BR)
| back to top |
BR: Bendamustine, Rituximab
Regimen
| Study | Evidence |
|---|---|
| Berentsen et al. 2017 | Phase II |
Chemotherapy
- Bendamustine 90 mg/m2 IV once per day on days 1 & 2
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
28-day cycle for 4 cycles
References
- Berentsen S, Randen U, Oksman M, Birgens H, Tvedt THA, Dalgaard J, Galteland E, Haukås E, Brudevold R, Sørbø JH, Næss IA, Malecka A, Tjønnfjord GE. Bendamustine plus rituximab for chronic cold agglutinin disease: results of a Nordic prospective multicenter trial. Blood. 2017 Jul 27;130(4):537-541. Epub 2017 May 22. link to original article contains verified protocol PubMed NCT02689986
Eculizumab monotherapy
| back to top |
Regimen
| Study | Evidence |
|---|---|
| Röth et al. 2018 (DECADE) | Phase II, <20 pts |
Eligible patients had symptomatic cold agglutinin-mediated hemolysis with a serum lactate dehydrogenase (LDH) level greater than or equal to 2 x upper limit of normal and a cold agglutinin titer greater than 1:64 at 4°C.
Immunosuppressive therapy
- Eculizumab (Soliris) as follows:
- Cycle 1: 600 mg IV once per day on days 1, 8, 15, 22
- Cycles 2 to 11: 900 mg IV once on day 1
Supportive medications
- Patients were vaccinated against Neisseria meningitidis or received "appropriate antibiotics" if vaccination occurred within 14 days of the first dose
28-day cycle for 1 cycle, then 14-day cycle for 11 cycles
References
- DECADE: Röth A, Bommer M, Hüttmann A, Herich-Terhürne D, Kuklik N, Rekowski J, Lenz V, Schrezenmeier H, Dührsen U. Eculizumab in cold agglutinin disease (DECADE): an open-label, prospective, bicentric, nonrandomized phase 2 trial. Blood Adv. 2018 Oct 9;2(19):2543-2549. link to original article link to PMC article PubMed NCT01303952
FR
| back to top |
FR: Fludarabine & Rituximab
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Berentsen et al. 2010 | Phase II | ORR: 76% |
Eligible patients had to be diagnosed with cold agglutinin disease and require therapy because of anemia, substantial cold-induced circulatory symptoms, or both.
Chemotherapy
- Fludarabine (Fludara) 40 mg/m2 PO once per day on days 1 to 5
Targeted therapy
- Rituximab (Rituxan) 375 mg/m2 IV once on day 1
28-day cycle for 4 cycles
References
- Berentsen S, Randen U, Vågan AM, Hjorth-Hansen H, Vik A, Dalgaard J, Jacobsen EM, Thoresen AS, Beiske K, Tjønnfjord GE. High response rate and durable remissions following fludarabine and rituximab combination therapy for chronic cold agglutinin disease. Blood. 2010 Oct 28;116(17):3180-4. Epub 2010 Jul 15. link to original article contains verified protocol PubMed NCT00373594
Rituximab monotherapy
| back to top |
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Berentsen et al. 2003 | Phase II | ORR: 54% |
| Schöllkopf et al. 2006 | Phase II | ORR: 45% |
Patients in Berentsen et al. 2003 were required to have cold agglutinin disease, as defined by the combination of chronic hemolysis and a cold agglutinin titer of 1:64 or higher, and a typical pattern for the direct antiglobulin test (DAT).
Immunosuppressive therapy
- Rituximab (Rituxan) 375 mg/m2 IV once per day on days 1, 8, 15, 22
28-day course
References
- Berentsen S, Ulvestad E, Gjertsen BT, Hjorth-Hansen H, Langholm R, Knutsen H, Ghanima W, Shammas FV, Tjønnfjord GE. Rituximab for primary chronic cold agglutinin disease: a prospective study of 37 courses of therapy in 27 patients. Blood. 2004 Apr 15;103(8):2925-8. Epub 2003 Dec 30. link to original article contains verified protocol PubMed
- Schöllkopf C, Kjeldsen L, Bjerrum OW, Mourits-Andersen HT, Nielsen JL, Christensen BE, Jensen BA, Pedersen BB, Taaning EB, Klausen TW, Birgens H. Rituximab in chronic cold agglutinin disease: a prospective study of 20 patients. Leuk Lymphoma. 2006 Feb;47(2):253-60. link to original article contains protocol PubMed
Sutimlimab monotherapy
Regimen
| Study | Evidence | Efficacy |
|---|---|---|
| Röth et al. 2021 | Phase II | ORR: 54% |
Targeted therapy
- Sutimlimab 6.5 g (for patients who weighed less than 75 kg at baseline) and 7.5g (for patients who weighed 75 kg or more)
7 day course for cycle 1 then every 14 days for 26 weeks