Bristol-Myers Squibb (BMS) recently announced that the U.S. Food and Drug Administration (FDA) has accepted a supplementary biologics license for the anti-PD-1 therapy Opdivo (Nivolumab, generic name: nivolumab) Application (sBLA), the sBLA seeking approval of Opdivo for the adjuvant treatment of adult patients with esophagus or gastroesophageal junction (GEJ) cancer who have undergone neoadjuvant chemoradiotherapy (CRT) and resection. The FDA has granted priority review to the sBLA and has designated the Prescription Drug User Fees Act (PDUFA) target date as May 20, 2021. Earlier this month, Opdivo's application for the aforementioned indications was also accepted by the European Medicines Agency (EMA), and a centralized review process has been initiated.

　　Opdivo was approved for listing in China in June 2018, becoming the first approved immuno-oncology (I-O) therapeutic drug in the Chinese market. In March 2020, the National Medical Products Administration (NMPA) approved Opdivo for the treatment of patients with advanced or recurrent gastric or gastroesophageal junction adenocarcinoma who had previously received two or more systemic treatment regimens. The approval of the indications for gastroesophageal junction adenocarcinoma is also the third that Opdivo has been approved in China after non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (SCCHN). Indications.

　　This application is based on the results of Phase 3 CheckMate-577 trial. Data show that in patients with esophageal cancer and GEJ cancer who received neoadjuvant CRT and surgical resection, compared with placebo, adjuvant Opdivo treatment doubled the disease-free survival (DFS) of patients (median DFS: 22.4 Months vs 11.0 months). Currently, the standard treatment for patients with esophageal cancer and GEJ cancer who have undergone neoadjuvant concurrent chemoradiation and surgical resection is surveillance follow-up. The results of this study confirmed for the first time that adjuvant therapy can significantly prolong the disease-free survival of such patients.

　　About CheckMate-5773 phase study data, safety and tolerability

　　CheckMate-577 is a randomized, double-blind, multi-center phase 3 study to evaluate the efficacy and safety of Opdivo as an adjuvant therapy for patients with resectable esophageal cancer and GEJ cancer who have not achieved complete pathological remission after neoadjuvant CRT. The primary endpoint of the study is disease-free survival (DFS), and the secondary endpoint is overall survival (OS). After receiving neoadjuvant concurrent chemoradiation and complete tumor resection (also known as "triple therapy"), 794 patients were randomly assigned to the placebo group (N=262) or the Opdivo group (N=532). Patients in the Opdivo group received Opdivo 240 mg intravenously every 2 weeks. After 16 weeks of continuous medication, Opdivo 480 mg was administered sequentially every 4 weeks until the disease recurred, intolerable toxicity occurred or the patient withdrew informed consent , The longest total treatment time is one year.

　　The results of the study were announced in September 2020. The data showed that: Compared with the placebo group, the Opdivo group showed a statistically significant and clinically significant improvement in the primary study endpoint disease-free survival (DFS). Compared with the placebo group (11.0 months; 95%CI: 8.3-14.3), the median DFS of the patients who received Opdivo treatment doubled (22.4 months vs 11.0 months; HR=0.69; p=0.0003) ). The median treatment time of patients in the Opdivo group was more than 10 months (10.1 months).

　　In the study, the safety of Opdivo monotherapy is consistent with previous research reports. Compared with placebo, Opdivo is safe and well tolerated. In the Opdivo group, most patients (89%) were able to receive a relative dose intensity of ≥ 90%. Among patients treated with Opdivo, the incidence of all grades and 3-4 treatment-related adverse events (TRAE) was 71% and 13%, respectively, compared with 46% and 6% in the placebo group. In the Opdivo group, less than 10% of patients had severe TRAE (all grades: 8%, grades 3-4: 5%), compared with 3% and 1% in the placebo group. In both groups, the discontinuation rate due to TRAEs of any grade was lower (Opdivo group: 9%, placebo group: 3%).

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