Immune checkpoint inhibition benefits in advanced NSCLC

With the approval of mRNA vaccines for COVID-19, there is a surge of mRNA therapeutics from malaria, HIV, cancer vaccines to mRNA/gRNA gene-editing treatments for cardiovascular diseases with endless possibilities. Lipid nanoparticles (LNPs) are often the delivery choice to effectively deliver and target the cells of interest. In order to produce safe and effective drugs, manufacturers of these modalities must characterize mRNA and the LNPs. Analytical tools such as LC-MS can accurately provide the necessary information to help address critical quality attributes.

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The management of cancer patients in clinical practice is undergoing a revolution due to the introduction of effective immunotherapy. Several different strategies currently rely on harnessing the immune system to fight tumors, leading to unprecedented therapeutic success. However, immunotherapy has also created the need to revisit the assessment of treatment benefit, possibly because its mechanism of action leads to effects on short- and long-term outcomes in a manner that differs from those of other modalities. For example, clinical trials of immune checkpoint inhibitors have disclosed novel issues related to the assessment of objective responses and have reinstated overall survival as a reliable primary endpoint, often to the detriment of progression-free survival (PFS). Moreover, pseudoprogression has become an issue in some tumor types, and the duration of responses has emerged as a relevant endpoint. In parallel, the limitations of current statistical methods of survival analysis that are based on the proportional-hazards assumption have become more apparent, and novel methods have been proposed.