ESMO Congress 2026

Tislelizumab is one of the ten approved anti-PD-1 antibodies ^[1], and its phase 3 evidence already spans multiple tumor types: in first-line advanced squamous NSCLC, tislelizumab plus paclitaxel or nab-paclitaxel with carboplatin improved PFS versus chemotherapy alone ^[3]; in second-line advanced esophageal squamous cell carcinoma, median OS was 8.6 vs 6.3 months in all patients (HR 0.70) and 10.3 vs 6.8 months in the PD-L1 TAP ≥10% population (HR 0.54) ^[4]; a global randomized phase 3 in first-line ESCC ^[5] and a phase 3 in first-line HER2-negative advanced gastric/gastro-oesophageal junction adenocarcinoma ^[6] have also been completed. Notably, these were mostly chemotherapy-combination or monotherapy designs; ^[1] notes that combining PD-1 blockade with other modalities may raise response rates, and ^[6] was explicitly restricted to HER2-negative patients — direct background for expanding tislelizumab into HER2-related combinations.

The tislelizumab-relevant readout at ESMO 2026 came from WUTSUP-02, exploring DV plus tislelizumab in high-risk UTUC (the post did not spell out the full name of DV): pCR was 28%, with higher responses in HER2 2+ & 3+; the poster also emphasized that, given the activity seen in HER2-low metastatic disease, the role of HER2 as a biomarker here still needs to be better understood. Separately at the same meeting, another GU readout was presented: HRQL data from EV-304 periop MIBC in the day-2 Rapid oral GU non-prostate session showed that EV + pembro was not associated with a clinically meaningful detriment in general HRQoL or cystectomy-specific HRQoL — a pembrolizumab-combination dataset running parallel to, and to be distinguished from, the tislelizumab storyline.

Relative to existing knowledge, WUTSUP-02 moves tislelizumab from the lung and GI solid tumors covered by ^[3][4][5][6] into the high-risk UTUC setting, using a combination with DV that echoes the direction described in ^[1], namely that pairing PD-1 blockade with other mechanisms can improve response rates; the higher responses in HER2 2+/3+ provide preliminary clues for patient enrichment and contrast with the HER2-negative population in ^[6].

As for limitations, the post only reported pCR 28% and the HER2-stratified responses; sample size, survival follow-up, protocol design details and any control-arm information were not disclosed, and the status of HER2 as a biomarker awaits further data, so the confirmatory value of this combination cannot yet be judged at this stage.