My study is part of the TACTI-002 trial. This is a phase II study in which eftilagimod, that is a soluble LAG-3 protein, is combined with pembrolizumab in different cohorts. In this congress we present the part B of the trial in which patients received this combination when they have progressed to the combination of immunotherapy plus chemotherapy or immunotherapy alone.
The study design is a phase II trial in which there are three cohorts, the first one is patients who are treatment naïve, the second one is part B, which is the one that we present in the congress, that includes patients who have progressed to immunotherapy alone or in combination with chemotherapy. The third one is patients with head and neck carcinoma that have progressed to standard chemotherapy.
In this part B study patients needed to have a confirmed progression with two consecutive CT scans and they received treatment with eftilagimod every two weeks during eight cycles and then every three weeks until one year, combined with pembrolizumab. After this year they received pembrolizumab alone to complete two years of treatment maximum. The primary endpoint of all these cohorts is objective response rate per iRECIST criteria.
The key results are related to the efficacy. This study included 36 patients, all of them previously treated with immunotherapy plus or without chemotherapy. The majority of patients were PD-L1 negative or PD-L1 low expression. What is important to underline is that in this population we found an objective response rate of about 8% with a disease control rate of 33%. We have to take into account that these are patients who have already progressed on immunotherapy. With a median overall survival of almost 10 months and a progression free survival of 2 months. But what is important also to underline is that the 6-month PFS was 25% and the overall survival rates at 12 and 21 months were 44% and 39% respectively.
How can these study results impact the treatment of NSCLC?
As our population was predominantly patients that have already progressed to immunotherapy and we observed that those patients with high PD-L1 expression and those that have already responded to the previous treatment were the ones that most benefitted from this strategy, this treatment opens a new door for new potential strategies for patients that have already progressed to immunotherapy.
These are preliminary data, it’s in a small cohort of patients but these data support further clinical investigation to innovate this treatment in patients that have already progressed to chemotherapy.