Full Press Release Details
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® .
About Onco360 Oncology Pharmacy Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Specialty Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer Benito.Fernandez@Onco360.com 516-640-1332
References:
• 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. JCO 39, 4012-4012(2021).
• National Cancer Institute. Cancer stat facts: esophageal cancer. https://seer.cancer.gov/statfacts/html/esoph.html .