The biomarker data provide a particularly important insight into the study population, showing that the combination treatment resulted in good clinical responses in patients considered less likely to respond to monotherapy checkpoint inhibition. This indicates a potential broad applicability for UV1 as a combination therapy to anti-PD1 checkpoint inhibitors in the real-world setting
[…]
In addition to the sub-analysis of the PD-L1 status, the study also evaluated four other key prognostic biomarkers, including baseline tumor mutational burden (TMB), predicted neoantigens, interferon gamma (IFN-gamma) gene signature, and levels of tumor infiltrating lymphocytes. Objective responses were observed in patients with low TMB, in patients with low neoantigen tumors, and in patients with tumors which were not enriched for IFN-gamma. These patients have tumors which previous clinical data have shown would be less responsive to treatment with pembrolizumab monotherapy in various cancer types. Lastly, the study also showed that clinical responders did not have higher levels of tumor infiltrating lymphocytes prior to treatment.[…]
The analyses of each of these five biomarkers signal efficacy in patients treated with UV1 in combination with pembrolizumab, regardless of tumor phenotype. These results are supportive of the addition of UV1 to checkpoint inhibitors, with the potential for improving both efficacy in current target patient populations and extending the use of immunotherapy to broader patient
populations in multiple cancer types, underserved by existing therapies.
Carlos de Sousa, CEO of Ultimovacs added: "We are excited about the clinical data generated on UV1 so far, with indications of efficacy also in hard-to-treat cancer patients with low levels of PD-L1. The biomarker data strengthen the
rationale of UV1 as backbone therapy in combination with checkpoint inhibitors.
These results provide a solid foundation for Ultimovacs’ extensive program of five randomized phase II trials of UV1 in different cancer indications, including malignant melanoma.
Med denne meldingen lener de seg langt frem i skoa. Dette var mer enn jeg hadde turt å håpe på. Å avvente avlesning ble plutselig enda enklere.
Slik jeg ser det, så er dette de mest lovende datapunktene vi har fått fra selskapet, utover helheten av positive signaler som peker i samme retning. Her får man attpåtil signaler på at UV1 også gir bedre effekt i pasienter hvor SOC/CPI er mindre sannsynlig at gir effekt i utgangspunktet.
