Tevimbra^® (tislelizumab)

FOR IMMEDIATE RELEASE:

Onco360^® Has Been Selected as The National Specialty Pharmacy Partner for Tevimbra^® (tislelizumab-jsgr)

Louisville, KY — October 1, 2024 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by Beigene for Tevimbra^® (tislelizumab), approved for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. This indication was approved based on the Phase III RATIONALE-302, (NCT03430843) clinical trial, which compared Tislelizumab to systemic chemotherapy.¹

Tevimbra^® (tislelizumab) is a PD-1 inhibitor that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2, releasing the PD-1 pathway mediated inhibition of the immune response, including the anti-tumor immune response. Esophageal cancer (EC) is the sixth most common cause of cancer-related deaths. ESCC is the most common histologic subtype of EC, accounting for nearly 90% of ECs. Esophageal cancer is a rapidly fatal disease. Over two-thirds of patients have advanced or metastatic disease at the time of diagnosis, with an expected five-year survival rate of less than 6% for those with distant metastases.²

“Onco360 is grateful for the opportunity to expand our partnership with the team at BeiGene and become the exclusive national specialty pharmacy provider for Tevimbra^®,” said Benito Fernandez. “The FDA approval of Tevimbra represents a new treatment option for patients suffering from unresectable or metastatic esophageal cancer, and as a chosen provider, we remain committed to providing patients, their caregivers, and providers with the highest level of quality and service.

The FDA approval of Tevimbra^® is based on the results of the Phase III RATIONALE-2 clinical trial, which evaluated 512 adult patients with unresectable advanced or metastatic esophageal (ESCC), randomized 1:1 to receive Tevimbra^® 200mg IV every 3 weeks or investigator’s choice IV systemic chemotherapy (paclitaxel, docetaxel, or irinotecan). All patients had received at least one prior anti-cancer systemic therapy. RATIONALE-302 demonstrated a statistically significant improvement in overall survival (OS) for patients randomized to Tevimbra^® as compared with systemic chemotherapy. 

The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were increased glucose (46%), decreased hemoglobin (45%), decreased lymphocytes (43%), decreased sodium (34%), decreased albumin (33%), increased alkaline phosphatase (32%), anemia (31%), fatigue (28%), increased AST (27%), musculoskeletal pain (24%), decreased weight (23%), increased ALT (23%), and cough (22%). 

Please see the full Prescribing Information for Tevimbra^®

Media Contact: Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

1. Lin Shen et al., RATIONALE 302: Randomized, phase 3 study of tislelizumab versus chemotherapy as second-line treatment for advanced unresectable/metastatic esophageal squamous cell carcinoma. JCO39, 4012-4012(2021).  
2. National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html