Follow up of MAIA Trial of Darzalex + lenalidomide + dexamethasone in patients with newly diagnosed multiple myeloma who are transplant ineligible are presented at ASH Meeting.- Janssen Biotech + Genmab A/S

Data from the follow-up (median of 36.4 months) of the Phase III MAIA study (Abstract #1875) was presented at ASH 2019 and demonstrated Darzalex in combination with lenalidomide and dexamethasone continued to significantly reduce the risk of disease progression or death by greater than 44 percent in patients with newly diagnosed multiple myeloma who are transplant ineligible, compared to treatment with Rd alone (HR = 0.56; 95 percent CI: 0.44-0.71; P<0.0001), with no new safety concerns after three years of follow-up with dazralex-rd. additionally time from randomization to progression on next-line treatment or death pfs2 favored the darzalex arm hr="0.69;" 95 percent ci 0.53-0.91 p="0.0079)." common grade 3 4 teaes occurring in 10 percent of patients in the darzalex-rd arm compared to the rd arm were neutropenia 51 percent vs. 35 percent lymphopenia 15 percent vs. 11 percent pneumonia 15 percent vs. 9 percent anemia 14 percent vs. 21 percent leukopenia 11 percent vs. 6 percent and hypokalemia 10 percent vs. 10 percent respectively. the most common serious teae in the darzalex-rd arm compared to the rd arm was pneumonia 14 percent vs. 9 percent respectively. the most common grade 3 4 infection rates were 36 percent in the darzalex-rd treatment arm compared with 27 percent in the rd arm.2 in the darzalex-rd arm 9 percent of patients discontinued treatment due to teaes compared with 18 percent of patients in the rd arm..>

About the MAIA Trial The randomized, open-label, multicenter Phase III study included 737 newly diagnosed patients aged 45-90 years old (median age of 73) with multiple myeloma ineligible for high-dose chemotherapy and ASCT. Patients were randomized to receive either Darzalex -Rd or Rd alone in 28-day cycles. In the Darzalex-Rd treatment arm, patients received Darzalex 16 mg/kg IV weekly for cycles 1�2, every two weeks for cycles 3�6 and every 4 weeks for cycle 7 and thereafter.