The AdvanTIG-202 study represents an open-label phase 2 clinical trial conducted on patients with recurrent or metastatic cervical cancer. The study aimed to assess the effectiveness of a combined therapy involving a PD-L1 inhibitor and a TIGIT inhibitor. Eligible patients had prior exposure to platinum chemotherapy, measurable lesions, and a good performance status upon enrollment.
During the initial phase (stage 1) of the trial, the treatment group received a combination of tislelizumab (TIS) and ociperlimab (OCI), while the control group received only TIS. Subsequently, additional patients were included in the treatment arm, receiving both TIS and OCI.
The rationale behind this combination therapy stems from the observed synergistic effects in pre-clinical and clinical studies involving other types of tumours. In cervical cancer, PD-L1 inhibition alone results in a modest 15% increase in objective response rate (ORR), with even lower rates in PD-L1 negative patients. By integrating a TIGIT inhibitor, this study investigates the potential enhancement of ORR outcomes.
The primary endpoint of the study was ORR, and the results indicated a significant improvement in ORR when compared to the histological control group treated with anti-PD-L1 alone. This improvement was particularly notable in the subgroup of patients with PD-L1 positive status.
Interestingly, the ORR increase was substantial in the TIS control group, surpassing even the combination treatment. However, the study did not aim to compare these results with the TIS-treated patients due to the imbalanced distribution of enrolled patients and the small sample size of the control group, preventing definitive conclusions.
Notably, there are no plans for a phase 3 trial; instead, the focus lies on exploring biomarkers to identify responders to the anti-PD-L1 and anti-TIGIT combination therapy.
Regarding safety, the trial demonstrated manageable toxicity levels, with only 13% of patients experiencing grade 3 or higher side effects. This finding appears more favourable than those observed in other studies involving immune checkpoint inhibitors in cervical cancer. However, cautious interpretation is necessary when making cross-trial comparisons.
Reference
Lee .J-Y. – AdvanTIG-202: Phase 2 Randomized, Multicenter, Open-Label Study of Tislelizumab (TIS) With or Without Ociperlimab (OCI) in Patients (pts) With Previously Treated Recurrent/Metastatic (R/M) Cervical Cancer (CC) – ESMO2023 #744MO
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