Janssen Pharmaceutical publishes the phase III clinical research data of darzalex (daratumumab) in MM patients

Recently, Johnson & Johnson's Janssen Pharmaceutical (http://www.chemdrug.com/) Company (http://www.chemdrug.com/company/) published the data of phase III clinical study Columba (mmy3012) to evaluate the treatment of relapsed / refractory multiple myeloma (mm) patients by subcutaneous injection (SC) darzalex (daratumumab) The results showed that compared with IV darzalex, SC darzalex had non inferiority in efficacy and pharmacokinetics, shorter administration time (5 minutes vs more than 3 hours), and lower incidence of transfusion related reactions (13% vs 35%) About darzalex SC, darzalex SC was developed by using the enhanze drug delivery technology of halozyme company (http://www.chemdrug.com/), and the formula contains recombinant human hyaluronidase PH20 (rhhuph20) At present, darzalex IV has been approved for the treatment of some patients with multiple myeloma (mm) Darzalex is the first McAb targeting CD30 in the world It has been approved for first-line, second-line and multi line treatment of multiple myeloma In 2018, its sales exceeded 2 billion US dollars It also has the potential to treat many other types of tumors with high expression of CD38 Columba Columba is a randomized, open label, multicenter study involving 522 patients with recurrent or refractory MM who have previously received at least three therapies, including a proteasome inhibitor (PI) and an immunomodulator (IMID), or whose disease is refractory to both a PI and an IMID In the study, darzalex SC treatment group (n = 263) received subcutaneous injection of darzalex (fixed dose 1800mg, prepared together with rhhuph20, the concentration of rhhuph20 is 2000 units / ml), once a week in cycle 1-2, twice a week in cycle 3-6, seven weeks and four weeks later Darzalex IV group (n = 259) received intravenous infusion of darzalex (dose 16 mg / kg), once a week in cycle 1-2, once every 2 weeks in cycle 3-6, once every 7 weeks and once every 4 weeks after that Each cycle is 28 days In the darzalex SC treatment group, darzalex was given in a fixed volume and subcutaneous injection was completed within 3-5 minutes In the darzalex IV treatment group, the median duration of the first, second and subsequent intravenous infusion of darzalex was 7.0 hours, 4.3 hours and 3.4 hours, respectively Two treatment groups continued treatment until disease progression or unacceptable toxicity The results showed that after a median follow-up of 7.5 months, the total response rate (ORR) and the first day of the third treatment cycle (ctrough) of darzalex SC group and darzalex IV group were non inferior In terms of safety, the most common adverse events (teaes) of darzalex SC compared with darzalex IV were thrombocytopenia (14% vs 14%), anemia (13% vs 14%) and neutropenia (13% vs 8%) The incidence of transfusion related reactions in darzalex SC was lower than that in darzalex IV (13% vs 35%, or = 0.28, 95% CI: 0.18-0.44, P < 0.0001) The main causes of treatment interruption included progressive diseases (43% in SC group, 44% in IV group) and adverse events (7% in SC group, 8% in IV group).