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

Area of Science:

• Oncology
• Immunology
• Pharmacology

Background:

• Effective cancer immunotherapy requires targeting somatic mutations with individualized approaches.
• Autogene cevumeran is an mRNA lipoplex-based immunotherapy targeting patient-specific neoantigens.

Purpose of the Study:

• Evaluate the safety and tolerability of autogene cevumeran.
• Assess its immunogenicity, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.

Main Methods:

• Phase 1 study of autogene cevumeran monotherapy (n=30) and combination with atezolizumab (n=183) in advanced solid tumors.
• Interim analysis of safety, immune responses, and clinical activity.

Main Results:

• Autogene cevumeran was well tolerated, eliciting neoantigen-specific T cell responses in 71% of patients.
• Responses, including CD8+ T cells, were sustained up to 23 months and found within tumors.
• Observed clinical activity, including objective responses in difficult-to-treat patients.

Conclusions:

• Autogene cevumeran demonstrates favorable safety and immunogenicity in advanced cancer patients.
• The findings support further development of autogene cevumeran, particularly in earlier treatment settings.