Safety and efficacy of durvalumab with R-CHOP or R2-CHOP in untreated, high-risk DLBCL: a phase 2, open-label trial
Patients with high-risk diffuse large B-cell lymphoma (DLBCL) have poor outcomes following first-line cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Evidence shows chemotherapy and immune checkpoint blockade can increase antitumor efficacy. This study investigated du...
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| Veröffentlicht in: | International journal of hematology 2022-02, Vol.115 (2), p.222-232 |
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| creator | Nowakowski, Grzegorz S. Willenbacher, Wolfgang Greil, Richard Larsen, Thomas S. Patel, Krish Jäger, Ulrich Manges, Robert F. Trümper, Lorenz Everaus, Hele Kalakonda, Nagesh Brown, Peter Jørgensen, Judit Meszaros Cunningham, David Dell’Aringa, Justine Fox, Brian Rubio, Neus Domper Kilavuz, Nurgul Casadebaig, Marie-Laure Manzke, Oliver Munoz, Javier |
| description | Patients with high-risk diffuse large B-cell lymphoma (DLBCL) have poor outcomes following first-line cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Evidence shows chemotherapy and immune checkpoint blockade can increase antitumor efficacy. This study investigated durvalumab, a programmed death-ligand 1 inhibitor, combined with R-CHOP or lenalidomide + R-CHOP (R
2
-CHOP) in newly diagnosed high-risk DLBCL. Patients received durvalumab 1125 mg every 21 days for 2–8 cycles + R-CHOP (non-activated B-cell [ABC] subtype) or R
2
-CHOP (ABC), then durvalumab consolidation (1500 mg every 28 days). Of 46 patients, 43 received R-CHOP and three R
2
-CHOP. All patients had the high-risk disease; 14 (30.4%) and eight (17.4%) had double- or triple-hit DLBCL, respectively. Following induction, 20/37 (54.1%) patients receiving durvalumab + R-CHOP achieved complete response (CR), and seven (18.9%) partial response (PR); 25 (67.6% [95% CI 50.2–82.0]) continued to consolidation and were progression-free at 12 months. Among efficacy-evaluable patients with double- or triple-hit DLBCL (
n
= 12), five achieved CR and five PR. Adverse events were generally consistent with R-CHOP. Correlative analyses did not identify conclusive biomarkers of response. Durvalumab + R-CHOP is feasible in DLBCL with no new safety signals, but the combination provided no greater benefit than R-CHOP. |
| doi_str_mv | 10.1007/s12185-021-03241-4 |
| format | Article |
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2
-CHOP) in newly diagnosed high-risk DLBCL. Patients received durvalumab 1125 mg every 21 days for 2–8 cycles + R-CHOP (non-activated B-cell [ABC] subtype) or R
2
-CHOP (ABC), then durvalumab consolidation (1500 mg every 28 days). Of 46 patients, 43 received R-CHOP and three R
2
-CHOP. All patients had the high-risk disease; 14 (30.4%) and eight (17.4%) had double- or triple-hit DLBCL, respectively. Following induction, 20/37 (54.1%) patients receiving durvalumab + R-CHOP achieved complete response (CR), and seven (18.9%) partial response (PR); 25 (67.6% [95% CI 50.2–82.0]) continued to consolidation and were progression-free at 12 months. Among efficacy-evaluable patients with double- or triple-hit DLBCL (
n
= 12), five achieved CR and five PR. Adverse events were generally consistent with R-CHOP. Correlative analyses did not identify conclusive biomarkers of response. Durvalumab + R-CHOP is feasible in DLBCL with no new safety signals, but the combination provided no greater benefit than R-CHOP.</description><identifier>ISSN: 0925-5710</identifier><identifier>EISSN: 1865-3774</identifier><identifier>DOI: 10.1007/s12185-021-03241-4</identifier><language>eng</language><publisher>Singapore: Springer Singapore</publisher><subject>Anticancer properties ; Antitumor activity ; Apoptosis ; B-cell lymphoma ; Biomarkers ; Cancer therapies ; Chemotherapy ; Consolidation ; Cyclophosphamide ; Cytotoxicity ; Doxorubicin ; Gene expression ; Health risks ; Hematology ; Hospitals ; Immune checkpoint ; Immunotherapy ; Ligands ; Lymphocytes B ; Lymphoma ; Medical research ; Medicine ; Medicine & Public Health ; Monoclonal antibodies ; Oncology ; Original Article ; Prednisone ; Risk ; Rituximab ; Safety ; Targeted cancer therapy ; Vincristine</subject><ispartof>International journal of hematology, 2022-02, Vol.115 (2), p.222-232</ispartof><rights>Japanese Society of Hematology 2021</rights><rights>Japanese Society of Hematology 2021.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c306t-46903e898f5b6563d91088e71126285511a2a1f6fc3badf9b8d03a0157f9abe33</citedby><cites>FETCH-LOGICAL-c306t-46903e898f5b6563d91088e71126285511a2a1f6fc3badf9b8d03a0157f9abe33</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12185-021-03241-4$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12185-021-03241-4$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids></links><search><creatorcontrib>Nowakowski, Grzegorz S.</creatorcontrib><creatorcontrib>Willenbacher, Wolfgang</creatorcontrib><creatorcontrib>Greil, Richard</creatorcontrib><creatorcontrib>Larsen, Thomas S.</creatorcontrib><creatorcontrib>Patel, Krish</creatorcontrib><creatorcontrib>Jäger, Ulrich</creatorcontrib><creatorcontrib>Manges, Robert F.</creatorcontrib><creatorcontrib>Trümper, Lorenz</creatorcontrib><creatorcontrib>Everaus, Hele</creatorcontrib><creatorcontrib>Kalakonda, Nagesh</creatorcontrib><creatorcontrib>Brown, Peter</creatorcontrib><creatorcontrib>Jørgensen, Judit Meszaros</creatorcontrib><creatorcontrib>Cunningham, David</creatorcontrib><creatorcontrib>Dell’Aringa, Justine</creatorcontrib><creatorcontrib>Fox, Brian</creatorcontrib><creatorcontrib>Rubio, Neus Domper</creatorcontrib><creatorcontrib>Kilavuz, Nurgul</creatorcontrib><creatorcontrib>Casadebaig, Marie-Laure</creatorcontrib><creatorcontrib>Manzke, Oliver</creatorcontrib><creatorcontrib>Munoz, Javier</creatorcontrib><title>Safety and efficacy of durvalumab with R-CHOP or R2-CHOP in untreated, high-risk DLBCL: a phase 2, open-label trial</title><title>International journal of hematology</title><addtitle>Int J Hematol</addtitle><description>Patients with high-risk diffuse large B-cell lymphoma (DLBCL) have poor outcomes following first-line cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Evidence shows chemotherapy and immune checkpoint blockade can increase antitumor efficacy. This study investigated durvalumab, a programmed death-ligand 1 inhibitor, combined with R-CHOP or lenalidomide + R-CHOP (R
2
-CHOP) in newly diagnosed high-risk DLBCL. Patients received durvalumab 1125 mg every 21 days for 2–8 cycles + R-CHOP (non-activated B-cell [ABC] subtype) or R
2
-CHOP (ABC), then durvalumab consolidation (1500 mg every 28 days). Of 46 patients, 43 received R-CHOP and three R
2
-CHOP. All patients had the high-risk disease; 14 (30.4%) and eight (17.4%) had double- or triple-hit DLBCL, respectively. Following induction, 20/37 (54.1%) patients receiving durvalumab + R-CHOP achieved complete response (CR), and seven (18.9%) partial response (PR); 25 (67.6% [95% CI 50.2–82.0]) continued to consolidation and were progression-free at 12 months. Among efficacy-evaluable patients with double- or triple-hit DLBCL (
n
= 12), five achieved CR and five PR. Adverse events were generally consistent with R-CHOP. Correlative analyses did not identify conclusive biomarkers of response. Durvalumab + R-CHOP is feasible in DLBCL with no new safety signals, but the combination provided no greater benefit than R-CHOP.</description><subject>Anticancer properties</subject><subject>Antitumor activity</subject><subject>Apoptosis</subject><subject>B-cell lymphoma</subject><subject>Biomarkers</subject><subject>Cancer therapies</subject><subject>Chemotherapy</subject><subject>Consolidation</subject><subject>Cyclophosphamide</subject><subject>Cytotoxicity</subject><subject>Doxorubicin</subject><subject>Gene expression</subject><subject>Health risks</subject><subject>Hematology</subject><subject>Hospitals</subject><subject>Immune checkpoint</subject><subject>Immunotherapy</subject><subject>Ligands</subject><subject>Lymphocytes B</subject><subject>Lymphoma</subject><subject>Medical research</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Monoclonal antibodies</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Prednisone</subject><subject>Risk</subject><subject>Rituximab</subject><subject>Safety</subject><subject>Targeted cancer 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Trümper, Lorenz ; Everaus, Hele ; Kalakonda, Nagesh ; Brown, Peter ; Jørgensen, Judit Meszaros ; Cunningham, David ; Dell’Aringa, Justine ; Fox, Brian ; Rubio, Neus Domper ; Kilavuz, Nurgul ; Casadebaig, Marie-Laure ; Manzke, Oliver ; Munoz, Javier</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c306t-46903e898f5b6563d91088e71126285511a2a1f6fc3badf9b8d03a0157f9abe33</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Anticancer properties</topic><topic>Antitumor activity</topic><topic>Apoptosis</topic><topic>B-cell lymphoma</topic><topic>Biomarkers</topic><topic>Cancer therapies</topic><topic>Chemotherapy</topic><topic>Consolidation</topic><topic>Cyclophosphamide</topic><topic>Cytotoxicity</topic><topic>Doxorubicin</topic><topic>Gene expression</topic><topic>Health risks</topic><topic>Hematology</topic><topic>Hospitals</topic><topic>Immune 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David</au><au>Dell’Aringa, Justine</au><au>Fox, Brian</au><au>Rubio, Neus Domper</au><au>Kilavuz, Nurgul</au><au>Casadebaig, Marie-Laure</au><au>Manzke, Oliver</au><au>Munoz, Javier</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Safety and efficacy of durvalumab with R-CHOP or R2-CHOP in untreated, high-risk DLBCL: a phase 2, open-label trial</atitle><jtitle>International journal of hematology</jtitle><stitle>Int J Hematol</stitle><date>2022-02-01</date><risdate>2022</risdate><volume>115</volume><issue>2</issue><spage>222</spage><epage>232</epage><pages>222-232</pages><issn>0925-5710</issn><eissn>1865-3774</eissn><abstract>Patients with high-risk diffuse large B-cell lymphoma (DLBCL) have poor outcomes following first-line cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (R-CHOP). Evidence shows chemotherapy and immune checkpoint blockade can increase antitumor efficacy. This study investigated durvalumab, a programmed death-ligand 1 inhibitor, combined with R-CHOP or lenalidomide + R-CHOP (R
2
-CHOP) in newly diagnosed high-risk DLBCL. Patients received durvalumab 1125 mg every 21 days for 2–8 cycles + R-CHOP (non-activated B-cell [ABC] subtype) or R
2
-CHOP (ABC), then durvalumab consolidation (1500 mg every 28 days). Of 46 patients, 43 received R-CHOP and three R
2
-CHOP. All patients had the high-risk disease; 14 (30.4%) and eight (17.4%) had double- or triple-hit DLBCL, respectively. Following induction, 20/37 (54.1%) patients receiving durvalumab + R-CHOP achieved complete response (CR), and seven (18.9%) partial response (PR); 25 (67.6% [95% CI 50.2–82.0]) continued to consolidation and were progression-free at 12 months. Among efficacy-evaluable patients with double- or triple-hit DLBCL (
n
= 12), five achieved CR and five PR. Adverse events were generally consistent with R-CHOP. Correlative analyses did not identify conclusive biomarkers of response. Durvalumab + R-CHOP is feasible in DLBCL with no new safety signals, but the combination provided no greater benefit than R-CHOP.</abstract><cop>Singapore</cop><pub>Springer Singapore</pub><doi>10.1007/s12185-021-03241-4</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | International journal of hematology, 2022-02, Vol.115 (2), p.222-232 |
| issn | 0925-5710 1865-3774 |
| language | eng |
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| source | SpringerLink Journals |
| subjects | Anticancer properties Antitumor activity Apoptosis B-cell lymphoma Biomarkers Cancer therapies Chemotherapy Consolidation Cyclophosphamide Cytotoxicity Doxorubicin Gene expression Health risks Hematology Hospitals Immune checkpoint Immunotherapy Ligands Lymphocytes B Lymphoma Medical research Medicine Medicine & Public Health Monoclonal antibodies Oncology Original Article Prednisone Risk Rituximab Safety Targeted cancer therapy Vincristine |
| title | Safety and efficacy of durvalumab with R-CHOP or R2-CHOP in untreated, high-risk DLBCL: a phase 2, open-label trial |
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