Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer

Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer

Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with the Fc-silencing ‘LALA’ mutation. The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy...

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Veröffentlicht in:European journal of cancer (1990) 2025-01, Vol.217, p.115255, Article 115255
Hauptverfasser: Laktionov, K., Smolin, A., Stroyakovskiy, D., Moiseenko, V., Dvorkin, M., Andabekov, T., Cheng, Y., Liu, B., Kozlov, V., Odintsova, S., Dvoretsky, S., Mochalova, A., Urda, M., Yi, T., Li, X., László, U., Müller, V., Bogos, K., Fadeeva, N., Musaev, G., Liu, Q., Kirtbaya, D., Shi, J., Gladkov, O., Narimanov, M., Semiglazova, T., Khasanova, A., Chovanec, J., Andrašina, I., Szabová, A., Rosinská, O., Sudekova, D., Zsolt, P-S., Ran, F., Sun, M., Jiang, O., Chen, R., Zhao, E., Liu, C., Tan, W., Pirmagomedov, A., Poddubskaya, E., Kislov, N., Shumskaya, I., Sorokina, I., Zinkina-Orikhan, A., Linkova, Yu, Fogt, S., Liaptseva, D., Siliutina, A., Basova, O., Kryukov, F.
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Sprache:eng
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Anti-PD-1
Non-small cell lung cancer
PD-L1 expression
Prolgolimab
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container_issue
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container_title European journal of cancer (1990)
container_volume 217
creator Laktionov, K.
Smolin, A.
Stroyakovskiy, D.
Moiseenko, V.
Dvorkin, M.
Andabekov, T.
Cheng, Y.
Liu, B.
Kozlov, V.
Odintsova, S.
Dvoretsky, S.
Mochalova, A.
Urda, M.
Yi, T.
Li, X.
László, U.
Müller, V.
Bogos, K.
Fadeeva, N.
Musaev, G.
Liu, Q.
Kirtbaya, D.
Shi, J.
Gladkov, O.
Narimanov, M.
Semiglazova, T.
Khasanova, A.
Chovanec, J.
Andrašina, I.
Szabová, A.
Rosinská, O.
Sudekova, D.
Zsolt, P-S.
Ran, F.
Sun, M.
Jiang, O.
Chen, R.
Zhao, E.
Liu, C.
Tan, W.
Pirmagomedov, A.
Poddubskaya, E.
Kislov, N.
Shumskaya, I.
Sorokina, I.
Zinkina-Orikhan, A.
Linkova, Yu
Fogt, S.
Liaptseva, D.
Siliutina, A.
Basova, O.
Kryukov, F.
description Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with the Fc-silencing ‘LALA’ mutation. The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS). After a median follow-up of 18 months, the median OS was not reached (95% CI, 22.28 – NA) in the prolgolimab-combination group vs 14.6 months (95% CI, 11.73 – 19.15) in the placebo-combination group (HR, 0.51; 95% CI, 0.35 – 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95% CI, 0.49 – 0.85, p = 0.0004). The only adverse events that were reported in at least 10% of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea. Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389) •Significant benefits in overall survival and progression free survival•OS and PFS benefits are retained in PD-L1 TPS
doi_str_mv 10.1016/j.ejca.2025.115255
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The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS). After a median follow-up of 18 months, the median OS was not reached (95% CI, 22.28 – NA) in the prolgolimab-combination group vs 14.6 months (95% CI, 11.73 – 19.15) in the placebo-combination group (HR, 0.51; 95% CI, 0.35 – 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95% CI, 0.49 – 0.85, p = 0.0004). The only adverse events that were reported in at least 10% of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea. Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. 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All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c1529-21836e1746204fa11918b809d958c2736c4849ad15692a4cfe60618e90e3f0543</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S095980492500036X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39879779$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Laktionov, K.</creatorcontrib><creatorcontrib>Smolin, A.</creatorcontrib><creatorcontrib>Stroyakovskiy, D.</creatorcontrib><creatorcontrib>Moiseenko, V.</creatorcontrib><creatorcontrib>Dvorkin, M.</creatorcontrib><creatorcontrib>Andabekov, T.</creatorcontrib><creatorcontrib>Cheng, Y.</creatorcontrib><creatorcontrib>Liu, B.</creatorcontrib><creatorcontrib>Kozlov, V.</creatorcontrib><creatorcontrib>Odintsova, S.</creatorcontrib><creatorcontrib>Dvoretsky, S.</creatorcontrib><creatorcontrib>Mochalova, A.</creatorcontrib><creatorcontrib>Urda, M.</creatorcontrib><creatorcontrib>Yi, T.</creatorcontrib><creatorcontrib>Li, X.</creatorcontrib><creatorcontrib>László, U.</creatorcontrib><creatorcontrib>Müller, V.</creatorcontrib><creatorcontrib>Bogos, K.</creatorcontrib><creatorcontrib>Fadeeva, N.</creatorcontrib><creatorcontrib>Musaev, G.</creatorcontrib><creatorcontrib>Liu, Q.</creatorcontrib><creatorcontrib>Kirtbaya, D.</creatorcontrib><creatorcontrib>Shi, J.</creatorcontrib><creatorcontrib>Gladkov, O.</creatorcontrib><creatorcontrib>Narimanov, M.</creatorcontrib><creatorcontrib>Semiglazova, T.</creatorcontrib><creatorcontrib>Khasanova, A.</creatorcontrib><creatorcontrib>Chovanec, J.</creatorcontrib><creatorcontrib>Andrašina, I.</creatorcontrib><creatorcontrib>Szabová, A.</creatorcontrib><creatorcontrib>Rosinská, O.</creatorcontrib><creatorcontrib>Sudekova, D.</creatorcontrib><creatorcontrib>Zsolt, P-S.</creatorcontrib><creatorcontrib>Ran, F.</creatorcontrib><creatorcontrib>Sun, M.</creatorcontrib><creatorcontrib>Jiang, O.</creatorcontrib><creatorcontrib>Chen, R.</creatorcontrib><creatorcontrib>Zhao, E.</creatorcontrib><creatorcontrib>Liu, C.</creatorcontrib><creatorcontrib>Tan, W.</creatorcontrib><creatorcontrib>Pirmagomedov, A.</creatorcontrib><creatorcontrib>Poddubskaya, E.</creatorcontrib><creatorcontrib>Kislov, N.</creatorcontrib><creatorcontrib>Shumskaya, I.</creatorcontrib><creatorcontrib>Sorokina, I.</creatorcontrib><creatorcontrib>Zinkina-Orikhan, A.</creatorcontrib><creatorcontrib>Linkova, Yu</creatorcontrib><creatorcontrib>Fogt, S.</creatorcontrib><creatorcontrib>Liaptseva, D.</creatorcontrib><creatorcontrib>Siliutina, A.</creatorcontrib><creatorcontrib>Basova, O.</creatorcontrib><creatorcontrib>Kryukov, F.</creatorcontrib><title>Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer</title><title>European journal of cancer (1990)</title><addtitle>Eur J Cancer</addtitle><description>Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with the Fc-silencing ‘LALA’ mutation. The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS). After a median follow-up of 18 months, the median OS was not reached (95% CI, 22.28 – NA) in the prolgolimab-combination group vs 14.6 months (95% CI, 11.73 – 19.15) in the placebo-combination group (HR, 0.51; 95% CI, 0.35 – 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95% CI, 0.49 – 0.85, p = 0.0004). The only adverse events that were reported in at least 10% of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea. Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389) •Significant benefits in overall survival and progression free survival•OS and PFS benefits are retained in PD-L1 TPS&lt;1% NSCLC•&lt;10% of therapy discontinuation due to safety concerns</description><subject>Anti-PD-1</subject><subject>Non-small cell lung cancer</subject><subject>PD-L1 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S.</creatorcontrib><creatorcontrib>Liaptseva, D.</creatorcontrib><creatorcontrib>Siliutina, A.</creatorcontrib><creatorcontrib>Basova, O.</creatorcontrib><creatorcontrib>Kryukov, F.</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>European journal of cancer (1990)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Laktionov, K.</au><au>Smolin, A.</au><au>Stroyakovskiy, D.</au><au>Moiseenko, V.</au><au>Dvorkin, M.</au><au>Andabekov, T.</au><au>Cheng, Y.</au><au>Liu, B.</au><au>Kozlov, V.</au><au>Odintsova, S.</au><au>Dvoretsky, S.</au><au>Mochalova, A.</au><au>Urda, M.</au><au>Yi, T.</au><au>Li, X.</au><au>László, U.</au><au>Müller, V.</au><au>Bogos, K.</au><au>Fadeeva, N.</au><au>Musaev, G.</au><au>Liu, Q.</au><au>Kirtbaya, D.</au><au>Shi, J.</au><au>Gladkov, O.</au><au>Narimanov, M.</au><au>Semiglazova, T.</au><au>Khasanova, A.</au><au>Chovanec, J.</au><au>Andrašina, I.</au><au>Szabová, A.</au><au>Rosinská, O.</au><au>Sudekova, D.</au><au>Zsolt, P-S.</au><au>Ran, F.</au><au>Sun, M.</au><au>Jiang, O.</au><au>Chen, R.</au><au>Zhao, E.</au><au>Liu, C.</au><au>Tan, W.</au><au>Pirmagomedov, A.</au><au>Poddubskaya, E.</au><au>Kislov, N.</au><au>Shumskaya, I.</au><au>Sorokina, I.</au><au>Zinkina-Orikhan, A.</au><au>Linkova, Yu</au><au>Fogt, S.</au><au>Liaptseva, D.</au><au>Siliutina, A.</au><au>Basova, O.</au><au>Kryukov, F.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer</atitle><jtitle>European journal of cancer (1990)</jtitle><addtitle>Eur J Cancer</addtitle><date>2025-01-21</date><risdate>2025</risdate><volume>217</volume><spage>115255</spage><pages>115255-</pages><artnum>115255</artnum><issn>0959-8049</issn><issn>1879-0852</issn><eissn>1879-0852</eissn><abstract>Prolgolimab is an IgG1 anti-PD-1 monoclonal antibody with the Fc-silencing ‘LALA’ mutation. The phase III DOMAJOR study assessed efficacy and safety of prolgolimab in combination with pemetrexed and platinum-based chemotherapy vs placebo in combination with pemetrexed and platinum-based chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC). 292 patients with advanced non-squamous NSCLC were randomized 1:1 to receive 4 cycles of pemetrexed, platinum-based drug and either prolgolimab (3 mg/kg Q3W) or placebo followed by prolgolimab/placebo with pemetrexed until disease progression or toxicity (≤36 months). The primary endpoint was overall survival (OS). After a median follow-up of 18 months, the median OS was not reached (95% CI, 22.28 – NA) in the prolgolimab-combination group vs 14.6 months (95% CI, 11.73 – 19.15) in the placebo-combination group (HR, 0.51; 95% CI, 0.35 – 0.73, p = 0.0001). The OS improvement was independent of PD-L1 status. Median progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) was 7.7 months in the prolgolimab-combination group and 5.5 months in the placebo-combination group (HR, 0.65; 95% CI, 0.49 – 0.85, p = 0.0004). The only adverse events that were reported in at least 10% of the patients that were significantly more frequent in the prolgolimab-combination group were blood creatinine increased and dyspnoea. Among patients with advanced NSCLC the addition of prolgolimab to pemetrexed and a platinum-based drug increased OS and PFS, with no new safety concerns. This benefit was retained in patients with PD-L1 negative tumors. (ClinicalTrials.gov, NCT03912389) •Significant benefits in overall survival and progression free survival•OS and PFS benefits are retained in PD-L1 TPS&lt;1% NSCLC•&lt;10% of therapy discontinuation due to safety concerns</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>39879779</pmid><doi>10.1016/j.ejca.2025.115255</doi></addata></record>
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ispartof European journal of cancer (1990), 2025-01, Vol.217, p.115255, Article 115255
issn 0959-8049
1879-0852
1879-0852
language eng
recordid cdi_proquest_miscellaneous_3161518519
source Elsevier ScienceDirect Journals
subjects Anti-PD-1
Non-small cell lung cancer
PD-L1 expression
Prolgolimab
title Prolgolimab with Chemotherapy as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer
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