MedicalResearch.com Interview with:
Dr James Kuo, MBBS
Medical oncologist and Deputy Medical Director
Scientia Clinical Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Immune checkpoint inhibitors (ICI) that have seen success in the treatment of patients with various tumour types have not been as effective in patients with metastatic pancreatic cancer and therefore immune-therapeutic agents of novel mechanism of action, in particular in combination with existing ICI, need to be investigated.
This study set out to test the safety and efficacy of pixatimod, a novel immunomodulatory agent, in combination with nivolumab, firstly in the dose escalation cohorts in patients with any solid tumour for the maximal tolerable dose, and then using this dose to further treat an expansion cohort of patients with pancreatic cancer. Altogether 16 patients had received the combination and in 10 patients in whom treatment response was evaluable, 4 patients experienced a clinical benefit and continued treatment in the trial, with 1 patient having a significant partial response now treated for 48 weeks. Interestingly, all these 4 patients had metastatic colorectal cancer. Side effect profile has been consistent with other immunotherapeutic agent combination and in the patients who had clinical benefit, no treatment related side effects were observed.
MedicalResearch.com: What should readers take away from your report?
Response: This combination of pixatimod and nivolumab shows promise in the dose escalation cohort for patients with metastatic colorectal cancer, in particular a subtype of metastatic colorectal cancer known as being microsatellite stable for which treatment with any immunotherapeutic agent in the past had been unsuccessful.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: While the dose expansion cohort of the trial now moves on to recruit patients with pancreatic cancer, this combination should be investigated in patients with microsatellite stable colorectal cancer as well. Further research in combination immunotherapeutic agents will continue to improve treatment for patients with cancer types that have been intrinsically resistant to single-agent immunotherapy.
Disclosures: I have received travel grant from Zuccero Therapeutics and BMS, both are sponsoring this trial.
EORTC-NCI-AACR 2018 publication:
Preliminary results from a Phase Ib study of pixatimod (PG545) in combination with nivolumab in patients with advanced solid tumours with an expansion cohort in patients with metastatic pancreatic cancer
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