Johnson & Johnson darzalex is approved by the European Union for the second-line treatment of multiple myeloma

Source: Sina pharmaceutical 2017-05-02 US pharmaceutical giant JNJ tumor pipeline recently received good news in EU regulation The European Commission (EC) has approved the expansion of the existing indications of targeting anticancer drug darzalex (daratumumab) for the second-line treatment of multiple myeloma (mm), specifically: the combination of darzalex and standard nursing program [lenalidomide (lenalidomide, an immunomodulator) + dexamethasone (a hormone)] or [bortezomib, a protein] Enzyme inhibitors) + dexamethasone] were used in adult patients with multiple myeloma (mm) who had previously failed to receive at least one regimen In the European Union, darzalex was first approved in May 2016 as a single drug therapy for adult patients with recurrent and refractory multiple myeloma who had previously received treatment (including: Pi, a protease inhibitor, and IMID, an immunomodulator) and whose progression was confirmed after the last treatment In the United States, darzalex was approved for the first time in November 2015 as a single drug therapy for the third and fourth line treatment of multiple myeloma; at the end of last year, the FDA further approved darzalex combined with the two standard nursing programs (lenalidomide + dexamethasone, bortezomib + dexamethasone) for the second line treatment of multiple myeloma (mm) The EU approved darzalex for second-line treatment, based on data from two phase III clinical studies Pollux (mmy3003) and castr (mmy3004), both of which were conducted in adult patients with multiple myeloma who had received at least one previous treatment Data from Pollux (mmy3003) study showed that compared with lenalidomide + dexamethasone combination therapy, darzalex + lenalidomide + dexamethasone triple therapy significantly reduced the risk of disease progression or death by 63% (P < 0.001) Data from the castr (mmy3004) study showed that darzalex + bortezomib + dexamethasone triple therapy significantly reduced the risk of disease progression or death by 61% (P < 0.001) compared with bortezomib + dexamethasone triple therapy In these two studies, the safety of darzalex combined standard nursing plan was consistent with that of darzalex single drug study and standard nursing plan study In Pollux (mmy3003) study, the most common level 3 or level 4 adverse events during darzalex combined with lenalidomide + dexamethasone treatment included neutropenia (51.9%), thrombocytopenia (12.7%), anemia (12.4%); the infusion reactions related to darzalex treatment occurred in 47.7% of patients, most of them were level 1 or level 2 In the castr (mmy3004) study, the most common level 3 or level 4 adverse events during the treatment of darzalex combined with bortezomib + dexamethasone included thrombocytopenia (45.3%), anemia (14.4%), neutropenia (12.8%); the infusion reactions related to darzalex treatment occurred in 98.2% of patients, most of them were level 1 or level 2 and occurred in the first infusion, level 3 occurred in 8.6% Of patients Torben Plesner, a researcher in the darzalex clinical study and a physician at the danmwaielle hospital in Denmark, said that the data from the Pollux study and the castr study showed that the darzalex combined standard nursing regimen significantly prolonged the progression free survival (PFS) and significantly reduced the risk of disease progression or death compared with the standard nursing regimen These data indicate that the combination of darzalex with proteasome inhibitors or immunomodulators is expected to bring clinical benefits to patients with multiple myeloma (mm) who have previously received first-line or multi-line treatment Multiple myeloma (mm) is a kind of hematological malignancy originated from bone marrow It can't be cured and has a high recurrence rate It is characterized by excessive proliferation of plasma cells The disease is the second most common haematological tumor, usually affecting the elderly over 65 years old, more common in men than in women It is estimated that in 2012, there were about 39000 new cases in the world According to the latest five-year survival data (2000-2007), as many as half of new patients in Europe live less than five years, and about 29% will die within one year after diagnosis Although the disease may be relieved after treatment, unfortunately, because there is no drug to cure the disease, the vast majority of patients will experience relapse Although some patients do not show symptoms in fact, most of them are diagnosed due to the symptoms including bone problems, low blood picture, high blood calcium, kidney problems or infection Patients with relapse after standard therapy (including proteasome inhibitors and immunomodulators) have limited choice of clinical treatment and poor prognosis Darzalex is the first CD38 targeting and cytolytic antibody drug approved for marketing in the world It has broad-spectrum killing activity and can target and combine the transmembrane extracellular enzyme CD38 highly expressed on the surface of multiple myeloma and multiple solid tumor cells It can induce the rapid death of tumor cells through a variety of immune-mediated mechanisms, including complement dependent cytotoxicity (CDC) and antibody dependence Sex cell-mediated cytotoxicity (ADCC), antibody dependent cell-mediated phagocytosis (ADCP) and apoptosis (apoptosis) In addition, darzalex also showed immunoregulation, which promoted tumor cell death by reducing the number of immunosuppressive cells in tumor microenvironment (including regulatory T-cells [T-regs], regulatory B cells [T-regs], myelogenous inhibitory cells) At present, Johnson & Johnson is promoting a comprehensive clinical development project to investigate the potential of darzalex in multiple myeloma across a range of treatment backgrounds, including five phase III clinical studies Darzalex is a product vigorously developed by Johnson & Johnson In addition to multiple myeloma, darzalex has the potential to treat other types of tumors with high expression of CD38 molecules, including diffuse large B-cell lymphocarcinoma (DLBCL), chronic lymphoblastic leukemia (CLL), acute lymphoblastic leukemia (all), plasma cell leukemia (PCL), acute myeloid leukemia (AML), follicular leukemia Sex lymphoma (FL) and mantle cell lymphoma (MCL) etc Additional studies to assess darzalex's treatment of these malignancies or precancerous diseases are ongoing or planned At the beginning of January this year, the tumor immunotherapy giant Bristol Myers Squibb (BMS) and Johnson & Johnson reached a strategic cooperation to investigate the treatment of hematological malignancies and multiple solid tumors by PD-1 immunotherapy opdivo combined with darzalex, including multiple myeloma (mm), non-small cell lung cancer (NSCLC), pancreatic cancer, colorectal cancer (CRC), three yin breast cancer (TNBC) and head and neck cancer This cooperation will further accelerate the rapid expansion of both sides in the field of Hematology and solid tumors (compiled by Sina pharmaceutical / newborn)