Stand alone treatment for nGBM?? Can you provide a link to any trial showing the efficacy of L as monotherapy/standalone treatment and documentation of that's what they applied for ??
I am not sure what the final approval is about. We know that keytruda was approved years ago. Without doubt, the combination of DCVax-L with Poly-iclc has been used for hundreds if not thousands compassionate use cases. The results from the combo trial are absolutely amazing. See the following abstract about RNA sequencing? Three patients from neoadjuvant PD1 inhibitor + DCVax-L group and three patients from DCVax-L + adjuvant PD1 inhibitor. How could Dr. Liau draw conclusion from such a small sample size? The only logical answer is the results are absolutely stunning. I have seen the significantly universal reduction of all mutated genes in the poly-iclc trial. We didn't see patients in poly-iclc trial had anti-tumor immune response so intense that patients had to go through surgery and take immunosuppressive drug to suppress immune response, did we? This can give us the indication how earth-shattering the results are. I don't think Merck anticipated the amazing results either.
If I were LP, I would present all the available results to MHRA and let MHRA do the multiple choice to show how progressive the institution really is.
Methods To investigate this mechanism of immunotherapy resistance, we performed single-cell RNA-sequencing (scRNAseq) on pre- and post-vaccination tumor-infiltrating immune cells from three recurrent GBM patients enrolled in the ATL-DC + neo-aPD1 clinical trial. Additionally, we integrated our previously published and newly generated scRNAseq data encompassing 21 immunotherapy-naive and 23 neo-aPD1-treated recurrent GBM samples for comparison, representing the largest single-cell resolution analysis of the GBM immune microenvironment to date (n = 50).