When selecting patients, we don’t want to take patients who are rapidly progressing and are going to go off the study soon. We need to be able to select the patients who are going to benefit from this durable and delayed induction of immune response.
What are the next steps?
Follow-up studies are going to determine if this could get into the market. Also, we want to choose the right patient population. We want to determine if this drug allows patients to delay their progression and live longer, whether they receive it in the maintenance setting, in comparison to another therapy, or in the maintenance setting after first-line chemotherapy.
I don’t think we'll have to focus as much on partial responses with this agent if we are using it as a single agent. However, we are not sure if it can cause more durable tumor growth arrest and improve survival for patients who then might go on to receive other therapies, or if that immune reduction will cause them to live longer.
How do you foresee an agent like this changing the treatment landscape?
It can potentially change the landscape for those patients with synovial or myxoid sarcoma who respond well to chemotherapy but ultimately progress. This treatment in those patients with metastatic disease allows them to live longer and can even be used in the adjuvant setting due to the high risk of recurrence. If we can get the immune response kicked in for patients who have these high-risk tumors early on, we might be able to potentially cure them and prevent relapses. That is the hope but it remains to be seen.
Is there anything else you would like to add?
The biomarker analysis is very interesting. There was a patient on the initial phase I study who had a partial response 1 year after entering the study and who was still in remission 2 years later.
We studied that patient’s biomarker profile in detail and there seems to be a hint regarding which patients are going to respond. The key is selecting that right patient population who is going to benefit from this.
Somaiah N, Chawla SP, Block MS, et al. Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS). J Clin Oncol. 2017; 35 (suppl; abstr 11006).