Onco360, a leading independent specialty pharmacy, has been selected by BeiGene as the exclusive national specialty pharmacy partner for Tevimbra (tislelizumab-jsgr). This partnership supports the distribution of Tevimbra, which is approved for treating adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
The FDA approval of Tevimbra was based on the Phase III RATIONALE-302 trial (NCT03430843), a study comparing tislelizumab to systemic chemotherapy. The trial's findings underscored the potential of Tevimbra in improving outcomes for patients with advanced ESCC who have limited treatment options.
Clinical Efficacy and Safety
The RATIONALE-302 trial randomized 512 adult patients with unresectable advanced or metastatic ESCC to receive either Tevimbra 200mg IV every 3 weeks or investigator’s choice of IV systemic chemotherapy (paclitaxel, docetaxel, or irinotecan). All patients had previously received at least one prior anti-cancer systemic therapy. The study demonstrated a statistically significant improvement in overall survival (OS) for patients treated with Tevimbra compared to those receiving systemic chemotherapy.
Common adverse reactions (≥ 20%) included increased glucose (46%), decreased hemoglobin (45%), decreased lymphocytes (43%), decreased sodium (34%), and anemia (31%).
Mechanism of Action
Tevimbra (tislelizumab) is a PD-1 inhibitor that functions by binding to PD-1 and blocking its interaction with PD-L1 and PD-L2. This action releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. By blocking this interaction, tislelizumab enhances the body's ability to fight cancer cells.
Esophageal Cancer Burden
Esophageal cancer (EC) is the sixth most common cause of cancer-related deaths globally. ESCC is the predominant histological subtype, accounting for approximately 90% of EC cases. The aggressive nature of esophageal cancer often leads to late-stage diagnoses, with over two-thirds of patients presenting with advanced or metastatic disease. The five-year survival rate for patients with distant metastases is less than 6%, highlighting the urgent need for more effective treatments.
Onco360's Commitment
"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, Chief Commercial Officer at Onco360. "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."
