[Asia Economy Reporter Oh Ju-yeon] CrystalGenomics announced on the 27th that Ivaltinostat demonstrated efficacy in the clinical phase 2 results report for conditional new drug sales approval.
Ivaltinostat is being developed as a triple combination therapy for pancreatic cancer (Ivaltinostat + Gemcitabine + Erlotinib). In this report, the median overall survival (median OS) in the patient group who completed the predetermined 6 or more treatment cycles (PP) was 11.7 months, showing a life extension improvement of 5.5 months compared to the existing standard treatment (Gemcitabine + Erlotinib combination), which was evaluated as proof of efficacy.
In particular, as a result of follow-up observation of subjects until October 20, it was confirmed that one pancreatic cancer patient was still alive. Including this patient, the mean overall survival (mean OS) extends to 13.2 months.
Additionally, in the elderly group aged 65 and over who completed the targeted 6 treatment cycles, significantly superior effects were observed compared to those who received less than 6 cycles (p-value<0.01), confirming usability regardless of age.
Among existing standard treatments, the FOLFIRINOX regimen (Leucovorin + 5-Fluorouracil + Irinotecan + Oxaliplatin quadruple therapy) has been limited in use for elderly patients aged 65 and over due to severe side effects.
From a safety perspective, compared to the Gemcitabine + Erlotinib combination therapy, the incidence rate of adverse reactions corresponding to side effects (Grade 3 or 4) was significantly improved, and no newly occurring severe adverse reactions were observed.
Adverse reactions such as skin lesions, diarrhea, nausea, and vomiting, which appeared in the Gemcitabine + Erlotinib combination therapy, were absent in the Ivaltinostat triple combination therapy, confirming that safety was rather improved due to the addition of Ivaltinostat.
Furthermore, compared to other standard treatments such as the FOLFIRINOX regimen and Gemzar-Abraxane combination therapy, significantly superior safety results were demonstrated.
The company stated, "In particular, indicators of severe side effects such as neutropenia, leukopenia, neuropathy, vomiting, and diarrhea were significantly improved."
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