[Asia Economy Reporter Hyunseok Yoo] CrystalGenomics announced on the 30th that it has submitted an Investigational New Drug application (IND) to the Ministry of Food and Drug Safety for the Phase 3 clinical trial of ‘Ivaltinostat,’ which is being developed as a first-line treatment for pancreatic cancer.
The Phase 3 clinical trial for pancreatic cancer will be conducted on 170 patients with unresectable locally advanced or metastatic pancreatic cancer. The test group will receive a combination of Ivaltinostat, gemcitabine, and erlotinib, while the control group will receive the currently most prescribed first-line treatment, the FOLFIRINOX regimen (oxaliplatin + irinotecan + leucovorin + fluorouracil).
The primary endpoints include overall survival (OS), safety (grade 3-4), progression-free survival (PFS), and disease control rate (DCR) improvements through the Ivaltinostat combination therapy compared to the FOLFIRINOX regimen, which is the existing standard treatment.
Once the Phase 3 clinical trial plan is approved, Professors Siyoung Song and Junghyun Cho from Yonsei University College of Medicine will serve as principal investigators, with the Severance Hospital Pancreatobiliary Cancer Center leading patient recruitment. The trial will be conducted using a randomized, open-label design.
In the preceding Phase 2 clinical trial, the median overall survival (mOS) of the per-protocol (PP) group, which completed six cycles of treatment, was 11.7 months, showing improvement compared to 5.5 months for the gemcitabine and erlotinib combination. Furthermore, adverse reactions such as skin lesions, diarrhea, nausea, and vomiting (grade 3-4 severe side effects) observed in the gemcitabine and erlotinib combination were not present in the Ivaltinostat combination therapy, demonstrating improved safety.
Notably, as of mid-this month, follow-up observations of subjects who received the Ivaltinostat combination in the Phase 2 trial confirmed that one patient has survived for approximately 25 months.
Professor Siyoung Song of Yonsei University Severance Hospital stated, “Ivaltinostat is an excellent drug candidate. Although the number of patients who completed the entire treatment cycle in the Phase 2 trial was insufficient, we believe that successful progress in the Phase 3 trial could mark a significant breakthrough in overcoming pancreatic cancer, a formidable challenge for humanity.”
A CrystalGenomics official said, “We received a fast-track designation from the Ministry of Food and Drug Safety in November last year for conditional approval and applied for orphan drug designation for conditional approval. However, during consultations with the Ministry, while efficacy and safety were sufficiently recognized, it was noted that the small number of subjects posed difficulties for orphan drug designation. Accordingly, we voluntarily withdrew the orphan drug designation application for conditional approval and plan to proceed with the Phase 3 clinical trial to formally apply for new drug approval.”
They added, “Since we have already confirmed extended overall survival and safety in the per-protocol (PP) group in the Phase 2 trial, we are confident that by increasing the number of subjects in the Phase 3 trial and further objectifying the data, we will be able to obtain final approval as a treatment for pancreatic cancer.”
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