Summary of Cardiff Oncology Clinical Update Conference Call Company and Industry - **Company**: Cardiff Oncology - **Industry**: Oncology, specifically focusing on metastatic colorectal cancer (mCRC) treatment Core Points and Arguments 1. **Clinical Trial Update**: Cardiff Oncology provided an update on the CARDUP004 trial, emphasizing the significance of the data shared, which reinforces previous findings and supports the potential of ondansertib in first-line RAS mutated mCRC treatment [4][32] 2. **Drug Candidate**: Ondansertib is a serine kinase inhibitor targeting PLK1, with a favorable pharmacological profile that minimizes toxicities seen in earlier PLK inhibitors [5][4] 3. **Trial Objectives**: The CARDUP004 trial aims to assess the efficacy and safety of ondansertib in combination with standard chemotherapy regimens, with a focus on establishing a registrational path with the FDA [6][31] 4. **Patient Demographics**: The trial included patients with documented KRAS or NRAS mutations and unresectable metastatic disease, with a total of 110 patients randomized [13][24] 5. **Efficacy Results**: The trial reported a 49% objective response rate (ORR) in the 30 mg ondansertib arm compared to 30% in the control arm, indicating a significant improvement [16][32] 6. **Progression-Free Survival (PFS)**: Early PFS data shows promising trends, with a dose-dependent effect favoring the 30 mg dose, although median PFS has not yet been reached [26][27] 7. **Safety Profile**: Ondansertib was well tolerated, with adverse event rates comparable to control arms, indicating a positive risk-benefit profile [25][45] 8. **Regulatory Path Forward**: Cardiff Oncology plans to engage with the FDA regarding the registrational program based on the data presented, aiming for discussions before the end of the year [31][36] Additional Important Content 1. **Historical Context**: Colorectal cancer remains a significant health issue, with a low five-year survival rate of 15% and a median PFS of less than one year for first-line treatments [11] 2. **Need for New Therapies**: There is an urgent need for new therapies in mCRC, particularly for patients with RAS mutations, as the last new drug approval in this area was over 20 years ago [12] 3. **Comparative Analysis**: The trial's results were compared to historical data, highlighting the need for careful interpretation of response rates and the importance of focusing on RAS mutated populations [69][70] 4. **Future Updates**: Cardiff Oncology anticipates providing further updates on the RAS mutated mCRC program by Q1 2026 [34] This summary encapsulates the key points discussed during the conference call, focusing on the advancements in Cardiff Oncology's clinical trials and the implications for the treatment of metastatic colorectal cancer.