A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer
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CV9201 is an RNActive®-based cancer immunotherapy encoding five non-small cell lung cancer-antigens: New York esophageal squamous cell carcinoma-1, melanoma antigen family C1/C2, survivin, and trophoblast glycoprotein. In a phase I/IIa dose-escalation trial, 46 patients with locally advanced (n = 7) or metastatic (n = 39) NSCLC and at least stable disease after first-line treatment received five intradermal CV9201 injections (400-1600 µg of mRNA). The primary objective of the trial was to assess safety. Secondary objectives included assessment of antibody and ex vivo T cell responses against the five antigens, and changes in immune cell populations. All CV9201 dose levels were well-tolerated and the recommended dose for phase IIa was 1600 µg. Most AEs were mild-to-moderate injection site reactions and flu-like symptoms. Three (7%) patients had grade 3 related AEs. No related grade 4/5 or related serious AEs occurred. In phase IIa, antigen-specific immune responses against ≥ 1 antigen were detected in 63% of evaluable patients after treatment. The frequency of activated IgD+CD38 hi B cells increased > twofold in 18/30 (60%) evaluable patients. 9/29 (31%) evaluable patients in phase IIa had stable disease and 20/29 (69%) had progressive disease. Median progression-free and overall survival were 5.0 months (95% CI 1.8-6.3) and 10.8 months (8.1-16.7) from first administration, respectively. Two- and 3-year survival rates were 26.7% and 20.7%, respectively. CV9201 was well-tolerated and immune responses could be detected after treatment supporting further clinical investigation.
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mRNA vaccines have shown good efficacy in the treatment of acute myelocytic leukemia (AML), non-small cell lung cancer (NSCLC), and melanoma.
“mRNA vaccines have shown good efficacy in the treatment of acute myelocytic leukemia (AML),339–341 non-small cell lung cancer (NSCLC),342,343 and melanoma344–348 (Table 3).”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [343]
Specific immune responses against at least one antigen were detected in 63% of patients after treatment, and the frequency of activated IgD+ CD38hi B cells increased by more than two-fold in 60% of evaluated patients.
“Specific immune responses against at least one antigen were detected in 63% of patients after treatment, and the frequency of activated IgD+ CD38hi B cells increased by more than two-fold in 60% of evaluated patients.343,353,354”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [343]
In a phase I/IIa trial of a RNactive-based vaccine for non-small cell lung carcinoma, common diagnostic indicators for autoimmunity were elevated in up to 20% of patients after a RNactive schedule of five intradermal injections (dose 400-1600 μg).
“In a phase I/IIa trial of a RNactive ® -based vaccine for non-small cell lung carcinoma (NSCLC), common diagnostic indicators for autoimmunity were found to be elevated up to 20% of the patients after a RNactive ® schedule of five intradermal injections (dose of 400-1600 µg) [187].”
From Three decades of messenger RNA vaccine development (2019) · cites this paper as [187]
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- Authors
- Sebastian, M., Schröder, A., Scheel, B., Hong, H. S., Muth, A., von Boehmer, L., Zippelius, A., Mayer, F., Reck, M., Atanackovic, D., Thomas, M., Schneller, F., Stöhlmacher, J., Bernhard, H., Gröschel, A., Lander, T., Probst, J., Strack, T., Wiegand, V., Gnad-Vogt, U., Kallen, K.-J., Hoerr, I., von der Muelbe, F., Fotin-Mleczek, M., Knuth, A., & Koch, S. D.
- Affiliations
- Goethe University Frankfurt (DE)
- Merck KGaA, Darmstadt (Germany) (DE)
- CureVac (Germany) (DE)
- University Hospital of Basel (CH)
- Universitätsklinikum Tübingen (DE)
- German Center for Lung Research (DE)
- Huntsman Cancer Institute (US)
- University Hospital Heidelberg (DE)
- TUM Klinikum (DE)
- University Hospital Carl Gustav Carus (DE)
- Klinikum Darmstadt (DE)
- Universitätsklinikum Aachen (DE)
- University Hospital Zurich (CH)
- Corresponding author
- Sebastian, Martin
- ORCID
- Venue
- Cancer Immunology, Immunotherapy
- Published
- 2019-02-15
- Volume
- 68
- Issue
- 5
- Pages
- 799-812
- ISSN
- 0340-7004 (ISSN-L)
- 1432-0851
- PMC
- PMC11028316
- OpenAlex
- W2911332984
- Cited by
- 209
- References
- 54
- Citations by year
- 2026: 22 · 2025: 37 · 2024: 32 · 2023: 39 · 2022: 28 · 2021: 22 · 2020: 24 · 2019: 5
- FWCI
- 7.89
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Licence
- www.springer.com/tdm (tdm)
- Locations
- Cancer Immunology Immunotherapy (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion)
- Funders
- CureVac AG
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › RNA Interference and Gene Delivery
- Keywords
- non-small cell lung cancer, metastatic non-small cell lung cancer, NY-ESO-1, survivin, trophoblast glycoprotein, dose escalation, safety, antibody response, T cell response, B cell activation, immune checkpoint blockade, survival
- MeSH terms
- Injection Site Reaction, Aged, Aged, 80 and over, Antigens, Neoplasm, B-Lymphocytes, Carcinoma, Non-Small-Cell Lung, Cells, Cultured, Female, Humans, Immunotherapy, Lung Neoplasms, Lymphocyte Activation, Male, Middle Aged, Neoplasm Staging, RNA, Messenger, T-Lymphocytes, Survival Analysis, Cancer Vaccines
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