BeOne’s Tislelizumab Now Available in Ireland, Offering a New First Line Immunotherapy Option for Advanced Oesophageal Cancer

London, UK. 10 March 2026. BeOne Medicines (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the Health Service Executive (HSE) in the Republic of Ireland has approved reimbursement of tislelizumab, in combination with platinum-based chemotherapy, for the first-line treatment of eligible adult patients with unresectable, locally advanced recurrent or metastatic oesophageal squamous cell carcinoma (OSCC) whose tumours express PD-L1.

From 10 March 2026, tislelizumab will be available to prescribe to eligible patients across Ireland through HSE-funded hospital oncology services, in line with reimbursement approval.

Oesophageal cancer has a relatively low five-year survival and, according to the National Cancer Registry Ireland, approximately 500 patients are diagnosed each year.^[i] OSCC is the most common subtype, accounting for nearly 90% of cases.^[ii] Squamous cell carcinoma represents one of the primary histological subtypes of oesophageal cancer globally.ⁱⁱ

The HSE reimbursement decision is based on results from the Phase 3 RATIONALE-306 trial, a randomised, double-blind, placebo-controlled study evaluating tislelizumab in combination with chemotherapy as a first-line treatment in 649 patients with unresectable, locally advanced recurrent or metastatic oesophageal squamous cell carcinoma.

The study met its primary endpoint and demonstrated a statistically significant improvement in overall survival in the intention-to-treat population. Median overall survival was 17.2 months for patients receiving tislelizumab in combination with chemotherapy compared with 10.6 months for those receiving chemotherapy alone (hazard ratio 0.66; 95% CI 0.54–0.80). In patients with PD-L1 expression ≥5%, median overall survival was 19.1 months versus 10.0 months, respectively (HR 0.62; 95% CI 0.49–0.79).

The safety profile of tislelizumab in combination with chemotherapy was consistent with the known profile of the individual agents. The most frequent serious adverse reactions (≥2%) were pneumonia, dysphagia, diarrhoea, fatigue and oesophageal stenosis. The most common adverse reactions were anaemia, fatigue, decreased appetite, nausea, constipation, decreased weight, diarrhoea, peripheral sensory neuropathy, vomiting and stomatitis.

James Harris, Interim General Manager, BeOne Medicines UK & Ireland, said: “This approval marks our first launch in solid tumours in Ireland and reflects our commitment to supporting patients with advanced oesophageal squamous cell carcinoma. We are pleased that eligible patients will now have access to tislelizumab as a treatment option, and we remain focused on working with the oncology community to support patient care in Ireland.”

Tislelizumab first received approval by the European Commission on 15 September 2023 for the second-line treatment of OSCC. It is approved in multiple advanced cancer indications across Europe, including in gastric and gastro-oesophageal junction adenocarcinoma, non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (SCLC) and nasopharyngeal carcinoma.