We investigated the use of cabozantinib in patients with relapsed/refractory germ cell tumour.
Can you describe the study design and the patient population enrolled?
This was a phase II single arm study. It used a Simon two-stage design and it enrolled patients with relapsed/refractory disease. So these patients had been through frontline cisplatin chemotherapy and at least one salvage regimen.
What signals of clinical activity were observed with cabozantinib in this heavily pretreated population?
Our primary outcome was clinical benefit rate which was defined as the proportion of CR, PR and stable disease for at least three months. We demonstrated a clinical benefit rate of 43.2% in this highly heavily pretreated patient population.
How might these findings influence future treatment strategies for refractory GCT?
This is a tough patient population to show clinical benefit in, especially in this heavily pretreated patient population. So I do think that this shows it provides an opportunity for patients to be on a drug that can give them stability of disease but also have fewer side effects than some of the other typical chemotherapy regimens that we have in germ cell tumour. Then the next step would be trying to try this earlier in germ cell tumour.
Is there anything else you would like to add?
Based off of this, these initial results, we do have an ongoing trial of zanzalintinib with oral etoposide. There is a safety lead-in in patients with relapsed/refractory disease but then once that shows safety it will move to the post high-dose chemotherapy maintenance phase. So trying to move this treatment paradigm earlier for germ cell tumour.