Senhwa Biosciences, Inc. announced that promising clinical data from their global phase 1b/2 trial, evaluating the combination of Silmitasertib plus Gemcitabine and Cisplatin compared to Gemcitabine and Cisplatin alone in the frontline treatment of patients with Cholangiocarcinoma (CCA) will be presented at the 2021 ASCO GI Cancers Symposium in San Francisco. The study met its primary endpoint during an interim analysis by demonstrating a statistically significant difference in the Silmitasertib plus Gemcitabine and Cisplatin Arm. These findings indicate a clinically meaningful improvement in progression-free survival (PFS) (P<0.05). Consequently, the trial was stopped early once superior efficacy was confirmed. The 2021 ASCO GI Cancer poster titled "Silmitasertib (CX-4945) in Combination with Gemcitabine and Cisplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic Cholangiocarcinoma, a Phase 1b/2 Study" is summarized here: Key Study Population and Outcomes Definition: A total of 88 patients were enrolled and define the intent-to-treat (ITT) population, of which 87 of these patients received Silmitasertib in the phase 1b (n=50) and phase 2 (n=37) portions of the study: All 87 patients were included in the safety population. 55 patients were able to complete at least one full cycle of therapy, without dosing interruption or dose reductions and form the modified intent-to-treat (mITT) population. The primary efficacy outcome measure was assessed with PFS. The efficacy findings for Silmitasertib compare favorably with those reported in the literature for Gemcitabine and Cisplatin in the BT22 study (which included 6-weekly tumor scans, as in their study; the BT22 study looked at Gemcitabine alone verses Gemcitabine and Cisplatin in combination): Median PFS in the mITT population (11.2 months) is a clinically meaningful improvement when compared to the study's Phase II control group (5.8 months). PFS was approximately 5 months longer than in the BT22 study (5.8 months), Median OS (Overall Survival) in the mITT population (17.4 months) was approximately 6 months longer than in the BT22 study (11.2 months), The ORR (Overall Response Rate) in the mITT population (32.1%) was higher than in the BT22 study (19.5%). The DCR (Disease Control Rate in the mITT population (79.3%) was also higher than that in the BT22 study (68.3%).