Johnson & Johnson (NYSE: JNJ) today announced the results from the Phase 2 open-label UNITY study of nipocalimab for the treatment of alloimmunized pregnant woman at risk of early onset severe (EOS) HDFN have been published in The New England Journal of Medicine (NEJM). The UNITY study met its primary endpoint with 54 percent of individuals receiving nipocalimab achieving a live birth at or after 32 weeks gestational age (GA) without the need for IUT.
Nipocalimab is currently the only therapy reported to be in clinical development for HDFN, a serious and rare condition that occurs when the blood types of a pregnant individual and the developing fetus are incompatible, potentially causing life-threatening anemia in the fetus or infant.2 These results showed that nipocalimab delayed or prevented severe fetal anemia requiring treatment prenatally and reduced the need for IUTs in pregnancies at high risk for recurrent EOS HDFN.
„The Phase 2 data published in the NEJM are encouraging, as the results support the potential of nipocalimab in the treatment of pregnant individuals with a history of severe HDFN, helping to establish a path forward for further development in this disease in a larger scale Phase 3 study,“ said Kenneth J. Moise Jr., M.D., Professor, Department of Women’s Health and Co-Director, Comprehensive Fetal Care Center at Dell Medical School of the University of Texas at Austin and lead study investigatorb. „For many patients, severe HDFN has a poor prognosis, and the current standard of care carries with it a high treatment burden, such as repeated IUTs and additional in-utero procedures that require access to specialty care and carry a risk to the life of the fetus. If approved, nipocalimab would be the first non-surgical treatment for pregnancies at high risk of HDFN.“
The multicenter, open-label, single-arm Phase 2 UNITY study assessed intravenous nipocalimab from 14-35 weeks in pregnancies at high risk for recurrent EOS HDFN.1 The primary endpoint of the study is live birth at ≥32 weeks GA without IUT. Study results showed the primary endpoint was achieved in 54 percent (7/13) of pregnancies versus the 10 percent historical benchmark (95 percent CI, 25.1-80.8; P<0.001).1 The NEJM manuscript includes new data that compares the outcomes of qualifying pregnanciesc and on-study (UNITY) pregnancies.1 The comparison revealed that study pregnancies had a higher proportion of live births (92 percent versus 38 percent), fewer participants requiring IUTs (85 percent versus 46 percent), a later median GA at first IUT (27 and 1/7 weeks versus 20 and 4/7 weeks) and a later median GA at delivery (36 4/7 weeks versus 23 and 6/7 weeks).1 Additionally, among pregnant individuals who joined the study, seven had a fetus that developed hydrops in their most recent qualifying pregnancy, whereas no incidences of hydrops occurred in the study pregnancies.
In the UNITY study, the most frequently reported adverse events were consistent with those common in pregnancy and HDFN.1 Serious side effects were consistent with HDFN or other pregnancy-related conditions including subchorionic hematoma and premature separation of the placenta.1 Infections and illnesses in infants of mothers exposed to nipocalimab were consistent with those typically observed in the neonatal and infancy period. No maternal or neonatal/infant deaths occurred in the study.1 One pregnancy resulted in fetal demise related to a complication of an IUT.
The UNITY study demonstrated positive efficacy and safety results which supports a favorable benefit risk profile for nipocalimab. Thus, the UNITY study results support further clinical development of nipocalimab for the treatment of severe HDFN.1
The AZALEA Phase 3 pivotal study is currently enrolling pregnant individuals at risk for severe HDFN who have a history of severe HDFN in a prior pregnancy(ies) to further assess the efficacy and safety of nipocalimab.4 In addition, Johnson & Johnson is conducting a Phase 3 study of nipocalimab in fetal and neonatal alloimmune thrombocytopenia (FNAIT), which has been considered to be the platelet counterpart of HDFN.
FNAIT is an alloimmune disorder of pregnancy that results when the pregnant person’s immune system attacks fetal or newborn platelets, resulting in thrombocytopenia and risk of bleeding, which can be life-threatening.6
Entdecke mehr von LabNews
Melde dich für ein Abonnement an, um die neuesten Beiträge per E-Mail zu erhalten.
