We just presented the clinical activity of gotistobart versus docetaxel in non-small cell lung cancer patients, particularly in squamous non-small cell lung cancer patients progressing on previous chemoimmunotherapy. The data we presented is stage 1 of this randomised global phase III trial.

What was the study design?

The study design is a two-stage randomised global phase III trial. Stage 1 is non-pivotal. On this stage totally 217 patients with treatment-resistant non-small cell lung cancer were randomised to a docetaxel arm and two arms of gotistobart with a different dose. We currently already finished enrolment and we presented data on the stage 1.

Based on the stage 1 data, so we are actively enrolling patients in the pivotal stage 2 part. So including the patients only with squamous non-small cell lung cancer patients who are going to receive gotistobart versus chemotherapy.

What were the key findings?

Gotistobart is a novel pH-sensitive anti-CTLA-4 antibody with an optimised Fc domain. The mechanism of action of this new generation of CTLA-4 antibody actually can promote depletion of regulatory T-cells in the tumour microenvironment. So we on the stage 1 non-pivotal study, in this meeting we presented data in the squamous non-small cell lung cancer patients. Totally there are 87 patients in this cohort, 45 patients received gotistobart and 42 patients received docetaxel. Gotistobart clearly demonstrated clinically meaningful overall survival benefit at the data cut-off with the following period of 14-15 months. The median overall survival has not been reached in the gotistobart arm while in the docetaxel arm the median overall survival is 10 months.

What could be the clinical significance of these results?

Previously the limitation for anti-CTLA-4 antibodies is because of the limited or narrowed therapeutic window because they have a high incidence of immune-related adverse events. This newer generation of anti-CTLA-4 antibodies actually have widened the therapeutic window. Even in the current we activate a higher dose and actually the toxicity profile is manageable with a predictable profile established in this class of drug.

What types of toxicities did you observe?

Between the gotistobart arm and the docetaxel arm any grade adverse events, as well as grade 3 and above adverse events, are comparable in the gotistobart arm and the chemo arm. When we look into the incidence for grade 3 and above adverse events, it’s a very typical profile on both arms. Prominent adverse events in the gotistobart arm are more immune related while in the