Immunotherapy for gastric cancer! Merck / Pfizer bavencio first line maintenance treatment phase III clinical failure, failed to extend the total survival period!

November 11, 2019 / BIOON / - Pfizer, a US pharmaceutical giant, and Merck KGaA, a partner, recently announced the top line results of the phase III javenlin gastric 100 study (nct02625610) on the treatment of gastric cancer by bavencio (avelumab), a PD-L1 tumor immunotherapy This is a multicenter, randomized, open label study in patients with HER2 negative, advanced (unresectable, locally advanced, or metastatic) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have not received chemotherapy for metastatic or locally advanced disease In the study, 805 patients were treated with oxaliplatin and 5-fluorouracil (5-FU) or oxaliplatin and capecitabine for 12 weeks 499 of them did not progress at the end of 12 weeks of chemotherapy, and these patients were randomly assigned to receive bavencio as maintenance therapy, or continue to receive the same chemotherapy until the disease progressed Patients who are not suitable for further chemotherapy should be given the best support care The primary end point of the study was total survival (OS) in all randomized patients (intention to treat [ITT] population) or PD-L1 positive (≥ 1%) population The results showed that bavencio had clinical activity in the first-line maintenance treatment, but in ITT group (n = 499) or PD-L1 positive group (n = 54), bavencio failed to reach the main end point of improving total survival (OS) compared with standard nursing (ITT group: HR = 0.91, 95% CI: 0.74-1.11; PD-L1 positive group: HR = 1.13, 95% CI: 0.57-2.23) No new safety signals were observed in this study, and the safety of bavencio was consistent with that observed in Javelin clinical development project At present, Pfizer and Merck are conducting a detailed analysis of the javenlin gastric 100 study in order to better understand the results At that time, all data of the study will be shared with the scientific community Dr Markus m ö hler, director of gastrointestinal oncology at Johannes Gutenberg University, Germany, who coordinated the study, said: "advanced gastric cancer is a refractory tumor, and there is an important unmet demand for additional therapeutic drugs In addition, gastric cancer rarely has immunogenicity, so far, no immunosuppressive checkpoint inhibitors show superior to the current chemotherapy care standard Since we have not yet determined the ideal strategy for integrating immunotherapy into continuous care, the results of the javelin gastric 100 study will provide important information for us to further understand this challenging disease and potential treatment options " Bavencio belongs to PD - (L) 1 tumor immunotherapy, which is a kind of tumor immunotherapy with great attention at present It aims to use the immune system of human body to resist cancer, and block the PD-1 / PD-L1 signal pathway to make cancer cells die It has the potential to treat various types of tumor Bavencio has been shown to be involved in both adaptive and innate immune functions in preclinical models Bavencio, by blocking the interaction between PD-L1 and PD-1 receptor, has been shown to release inhibition of T cell-mediated anti-tumor immune response in preclinical models Pfizer and Merck signed an agreement of up to US $2.85 billion in November 2014 to enter the PD - (L) 1 field At present, the two sides are promoting the javelin clinical development project, which involves more than 15 different types of tumors and more than 10000 patients In addition to gastric / gastroesophageal junction adenocarcinoma, these tumor types include ovarian cancer, breast cancer, head and neck cancer, Merkel cell cancer, non-small cell lung cancer, renal cell cancer and urothelial cancer In the U.S., bavencio was approved by the U.S FDA in March 2017 for the treatment of metastatic Merkel cell carcinoma (MCMC) in pediatrics and adults aged 12 and over This approval makes bavencio the first tumor immunotherapy in the world to treat MCMC, which is a worse invasive skin cancer than melanoma In May 2017, bavencio was approved by the US FDA for: (1) patients with locally advanced or metastatic urothelial carcinoma (MUC) during or after chemotherapy with platinum; (2) patients with locally advanced or metastatic urothelial carcinoma (MUC) who underwent preoperative (neoadjuvant) or postoperative (adjuvant) chemotherapy with platinum for 12 months In May this year, bavencio and tyrosine kinase inhibitor inlyta (axitinib, acitinib) were approved by the FDA as the first-line treatment for patients with advanced renal cell carcinoma (RCC) Original source: EMD Serono and Pfizer provide update on phase III javelin gastric 100 trial