Trial results for the Phase 2 PORCUPINE2 study (NCT04907851) investigating pembrolizumab in combination with RXC004 for advanced solid tumors were posted on ClinicalTrials.gov on 2025-03-17. The study reported an Objective Response Rate (ORR) of 0% for the combination therapy in Module 3 for advanced biliary tract cancer. Monotherapy with RXC004 showed an ORR of 16.7% in RNF43 mutated pancreatic cancer and 5.0% in biliary tract cancer.
Background
The PORCUPINE2 study (NCT04907851) aimed to evaluate the preliminary efficacy and safety of RXC004 monotherapy and in combination with pembrolizumab in advanced solid tumors that had progressed following standard of care treatment.
Trial design
The PORCUPINE2 study (NCT04907851) was a Phase 2, completed trial that enrolled 45 participants. The study investigated RXC004 monotherapy and RXC004 in combination with pembrolizumab in patients with advanced solid tumors after progression on standard of care therapy. Specific conditions included RNF43 mutated advanced (unresectable)/metastatic pancreatic cancer (Stage III/IV) and advanced (unresectable)/metastatic biliary tract cancer (Stage III/IV).
Key results
The trial results provided several outcome measurements across different modules:
- Objective Response Rate (ORR):
- For RXC004 monotherapy in Module 1 (RNF43 Mutated Advanced Pancreatic Cancer), the ORR was 16.7% (percentage of participants).
- For RXC004 monotherapy in Module 2 (Advanced Biliary Tract Cancer), the ORR was 5.0% (percentage of participants).
- For RXC004 in combination with pembrolizumab in Module 3 (Advanced Biliary Tract Cancer), the ORR was 0% (percentage of participants).
- Progression Free Survival Rate at 6 Months:
- For RXC004 monotherapy in Module 2 (Advanced Biliary Tract Cancer), the rate was 6.1% (percentage of participants). Data for Module 1 was not available.
- Disease Control Rate (DCR):
- In Module 1 (RNF43 Mutated Advanced Pancreatic Cancer), the DCR was 16.7% (percentage of participants).
- In Module 2 (Advanced Biliary Tract Cancer), the DCR was 25.0% (percentage of participants).
- In Module 3 (Advanced Biliary Tract Cancer Combination Therapy), the DCR was 31.6% (percentage of participants).
- Median Progression Free Survival (PFS):
- In Module 1 (RNF43 Mutated Advanced Pancreatic Cancer), the median PFS was 1.4 months.
- In Module 2 (Advanced Biliary Tract Cancer), the median PFS was 1.4 months.
- In Module 3 (Advanced Biliary Tract Cancer Combination Therapy), the median PFS was 1.41 months.
- Best Percentage Change in Tumor Size:
- In Module 1 (RNF43 Mutated Advanced Pancreatic Cancer), the median change was 41.67% (Percentage change in tumour size).
What this means
The results from the PORCUPINE2 trial provide preliminary efficacy data for RXC004 as monotherapy and in combination with pembrolizumab in advanced solid tumors. The observed 0% Objective Response Rate for the combination therapy in advanced biliary tract cancer (Module 3) suggests a lack of objective responses in this specific setting. While monotherapy showed some ORR (16.7% in pancreatic cancer, 5.0% in biliary tract cancer), the median Progression Free Survival across all modules was consistently low at approximately 1.4 months. These findings offer insights into the activity of RXC004, alone and with pembrolizumab, in these difficult-to-treat cancer types, particularly after progression on standard therapies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT04907851, titled "A Study to Assess RXC004 Efficacy in Advanced Solid Tumours After Progression on Standard of Care (SoC) Therapy (PORCUPINE2)," were posted on 2025-03-17 on clinicaltrials.gov.