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Autogene cevumeran with or without atezolizumab in advanced solid tumors: a phase 1 trial

Effective targeting of somatic cancer mutations to enhance the efficacy of cancer immunotherapy requires an individualized approach. Autogene cevumeran is a uridine messenger RNA lipoplex-based individualized neoantigen-specific immunotherapy designed from tumor-specific somatic mutation data obtain...

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Hauptverfasser: Lopez, Juanita Suzanne (VerfasserIn) , Powles, Thomas (VerfasserIn) , Braiteh, Fadi (VerfasserIn) , Siu, Lillian L. (VerfasserIn) , LoRusso, Patricia (VerfasserIn) , Friedman, Claire F. (VerfasserIn) , Balmanoukian, Ani S. (VerfasserIn) , Gordon, Michael (VerfasserIn) , Yachnin, Jeffrey (VerfasserIn) , Rottey, Sylvie (VerfasserIn) , Karydis, Ioannis (VerfasserIn) , Fisher, George A. (VerfasserIn) , Schmidt, Marcus (VerfasserIn) , Schuler, Martin (VerfasserIn) , Sullivan, Ryan J. (VerfasserIn) , Burris, Howard A. (VerfasserIn) , Galvao, Vladimir (VerfasserIn) , Henick, Brian S. (VerfasserIn) , Dirix, Luc (VerfasserIn) , Jäger, Dirk (VerfasserIn) , Ott, Patrick A. (VerfasserIn) , Wong, Kit Man (VerfasserIn) , Jerusalem, Guy (VerfasserIn) , Schiza, Aglaia (VerfasserIn) , Fong, Lawrence (VerfasserIn) , Steeghs, Neeltje (VerfasserIn) , Leidner, Rom S. (VerfasserIn) , Rittmeyer, Achim (VerfasserIn) , Laurie, Scott A. (VerfasserIn) , Gort, Eelke (VerfasserIn) , Aljumaily, Raid (VerfasserIn) , Melero, Ignacio (VerfasserIn) , Sabado, Rachel L. (VerfasserIn) , Rhee, Ina (VerfasserIn) , Mancuso, Michael R. (VerfasserIn) , Müller, Lars (VerfasserIn) , Fine, Gregg D. (VerfasserIn) , Yadav, Mahesh (VerfasserIn) , Kim, Leesun (VerfasserIn) , Leveque, Vincent J. P. (VerfasserIn) , Robert, Alberto (VerfasserIn) , Darwish, Martine (VerfasserIn) , Qi, Ting (VerfasserIn) , Zhu, Jiawen (VerfasserIn) , Zhang, Jingbin (VerfasserIn) , Twomey, Patrick (VerfasserIn) , Rao, Gautham K. (VerfasserIn) , Low, Donald W. (VerfasserIn) , Petry, Chris (VerfasserIn) , Lo, Amy A. (VerfasserIn) , Schartner, Jill M. (VerfasserIn) , Delamarre, Lélia (VerfasserIn) , Mellman, Ira (VerfasserIn) , Löwer, Martin (VerfasserIn) , Müller, Felicitas (VerfasserIn) , Derhovanessian, Evelyna (VerfasserIn) , Cortini, Andrea (VerfasserIn) , Manning, Luisa (VerfasserIn) , Maurus, Daniel (VerfasserIn) , Brachtendorf, Sebastian (VerfasserIn) , Lörks, Verena (VerfasserIn) , Omokoko, Tana (VerfasserIn) , Godehardt, Eva (VerfasserIn) , Becker, Dirk (VerfasserIn) , Hawner, Christine (VerfasserIn) , Wallrapp, Christine (VerfasserIn) , Albrecht, Christian (VerfasserIn) , Kröner, Christoph (VerfasserIn) , Tadmor, Arbel D. (VerfasserIn) , Diekmann, Jan (VerfasserIn) , Vormehr, Mathias (VerfasserIn) , Jork, Anette (VerfasserIn) , Paruzynski, Anna (VerfasserIn) , Lange, Maren Denise (VerfasserIn) , Blake, Jonathon (VerfasserIn) , Hennig, Oliver (VerfasserIn) , Kuhn, Andreas N. (VerfasserIn) , Sahin, Ugur (VerfasserIn) , Türeci, Özlem (VerfasserIn) , Camidge, David Ross (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 6 January 2025
In: Nature medicine
Year: 2025, Jahrgang: 31, Heft: 1, Pages: 152-164
ISSN:1546-170X
DOI:10.1038/s41591-024-03334-7
Online-Zugang:Verlag, kostenfrei, Volltext: https://doi.org/10.1038/s41591-024-03334-7
Verlag, kostenfrei, Volltext: https://www.nature.com/articles/s41591-024-03334-7
Volltext
Verfasserangaben:Juanita Lopez, Thomas Powles, Fadi Braiteh, Lillian L. Siu, Patricia LoRusso, Claire F. Friedman, Ani S. Balmanoukian, Michael Gordon, Jeffrey Yachnin, Sylvie Rottey, Ioannis Karydis, George A. Fisher, Marcus Schmidt, Martin Schuler, Ryan J. Sullivan, Howard A. Burris, Vladimir Galvao, Brian S. Henick, Luc Dirix, Dirk Jaeger, Patrick A. Ott, Kit Man Wong, Guy Jerusalem, Aglaia Schiza, Lawrence Fong, Neeltje Steeghs, Rom S. Leidner, Achim Rittmeyer, Scott A. Laurie, Eelke Gort, Raid Aljumaily, Ignacio Melero, Rachel L. Sabado, Ina Rhee, Michael R. Mancuso, Lars Muller, Gregg D. Fine, Mahesh Yadav, Leesun Kim, Vincent J. P. Leveque, Alberto Robert, Martine Darwish, Ting Qi, Jiawen Zhu, Jingbin Zhang, Patrick Twomey, Gautham K. Rao, Donald W. Low, Chris Petry, Amy A. Lo, Jill M. Schartner, Lélia Delamarre, Ira Mellman, Martin Löwer, Felicitas Müller, Evelyna Derhovanessian, Andrea Cortini, Luisa Manning, Daniel Maurus, Sebastian Brachtendorf, Verena Lörks, Tana Omokoko, Eva Godehardt, Dirk Becker, Christine Hawner, Christine Wallrapp, Christian Albrecht, Christoph Kröner, Arbel D. Tadmor, Jan Diekmann, Mathias Vormehr, Anette Jork, Anna Paruzynski, Maren Lang, Jonathon Blake, Oliver Hennig, Andreas N. Kuhn, Ugur Sahin, Özlem Türeci, D. Ross Camidge

MARC

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520 |a Effective targeting of somatic cancer mutations to enhance the efficacy of cancer immunotherapy requires an individualized approach. Autogene cevumeran is a uridine messenger RNA lipoplex-based individualized neoantigen-specific immunotherapy designed from tumor-specific somatic mutation data obtained from tumor tissue of each individual patient to stimulate T cell responses against up to 20 neoantigens. This ongoing phase 1 study evaluated autogene cevumeran as monotherapy (n = 30) and in combination with atezolizumab (n = 183) in pretreated patients with advanced solid tumors. The primary objective was safety and tolerability; exploratory objectives included evaluation of pharmacokinetics, pharmacodynamics, preliminary antitumor activity and immunogenicity. Non-prespecified interim analysis showed that autogene cevumeran was well tolerated and elicited poly-epitopic neoantigen-specific responses, encompassing CD4+ and/or CD8+ T cells, in 71% of patients, most of them undetectable at baseline. Responses were detectable up to 23 months after treatment initiation. CD8+ T cells specific for several neoantigens constituted a median of 7.3% of circulating CD8+ T cells, reaching up to 23% in some patients. Autogene cevumeran-induced T cells were found within tumor lesions constituting up to 7.2% of tumor-infiltrating T cells. Clinical activity was observed, including one objective response in monotherapy dose escalation and in two patients with disease characteristics unfavorable for response to immunotherapy treated in combination with atezolizumab. These findings support the continued development of autogene cevumeran in earlier treatment lines. ClinicalTrials.gov registration: NCT03289962. 
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SRT |a LOPEZJUANIAUTOGENECE6202 

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