Interim findings from the Phase I dose escalation segment of the mRNA cancer immunotherapy study (mRNA-4359) indicate potential benefits for patients with advanced solid tumors. This experimental immunotherapy is specifically aimed at individuals with lung cancer, melanoma, and other solid malignancies. A group of nineteen patients at advanced stages of cancer underwent treatment with one to nine doses of this immunotherapy. Researchers observed that the treatment triggered an immune response against the cancer cells and was mostly well-tolerated by the patients. Reported side effects included fatigue, pain at the injection site, and fever.
Interim findings from the Phase I dose escalation segment of the mRNA cancer immunotherapy study (mRNA-4359) indicate potential benefits for patients with advanced solid tumors.
This experimental immunotherapy targets patients suffering from lung cancer, melanoma, and various other solid tumors. Nineteen advanced-stage cancer patients received between one and nine doses of the treatment. Results show that the immunotherapy successfully initiated an immune response and was generally well-tolerated, with mild side effects such as fatigue, pain at the injection site, and fever.
The outcomes from the Phase I trial, which is the first human study of this therapy, will be discussed on Saturday, September 14th, at the European Society of Medical Oncology conference in Barcelona. The presentation will be led by the UK Chief Investigator from King’s College London and Guy’s and St Thomas’ NHS Foundation Trust, with the trial being sponsored by Moderna.
This mRNA immunotherapy represents one of many cancer vaccines currently undergoing clinical trials globally. It operates by training patients’ immune systems to recognize common tumor markers, allowing the body to target and eliminate cancer cells that express these markers, while potentially removing cells that might hinder immune response.
The Phase I trial was primarily designed to assess the safety and tolerability of the immunotherapy, with secondary and tertiary goals involving the evaluation of radiographic and immunological responses.
Among the sixteen patients evaluated, eight demonstrated that their tumors neither grew nor developed new growths.
Additionally, data indicated that the mRNA immunotherapy could effectively stimulate the immune system, leading to the generation of immune cells in the bloodstream capable of recognizing two key proteins (PD-L1 and IDO1). Some patients showed increased levels of vital immune cells that could attack cancer cells, alongside reduced levels of immune cells that might inhibit effective cancer treatment.
Study authors caution that these results should be viewed with care due to the small sample size and the study’s primary focus on safety and optimal dose determination. Nevertheless, these encouraging preliminary findings justify further research into mRNA-4359.
The trial is ongoing and continues to recruit patients with melanoma and lung cancer in tandem with the immunotherapy drug pembrolizumab to gather more data about the therapy’s safety and efficacy.
The UK Chief Investigator, Dr. Debashis Sarker, who is a Clinical Reader in Experimental Oncology at King’s College London and a medical oncology consultant at Guy’s and St Thomas’ NHS Foundation Trust, remarked, “This study evaluating an mRNA cancer immunotherapy marks an essential initial step in on the path to potentially develop new treatments for patients with advanced cancers.”
“We’ve demonstrated that this therapy is generally well tolerated without severe side effects and has the potential to activate the immune system in a manner that may prove beneficial in treating cancer effectively. However, as this study has included only a limited number of patients thus far, it’s premature to ascertain its effectiveness for those with advanced cancer stages.”
“The ongoing trial is a significant international collaboration involving the UK, USA, Spain, and Australia.”
Kyle Holen, M.D., Moderna’s Senior Vice President and Head of Development for Therapeutics and Oncology, commented, “We are heartened by the Phase 1 results of mRNA-4359, which showcase its ability to induce robust antigen-specific T-cell responses while maintaining an acceptable safety profile.”
“This innovative approach could be pivotal in transforming the tumor microenvironment into one that is more conducive to immune responses, potentially providing new hope for patients with advanced solid tumors.”
