Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma
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ORIGINAL ARTICLE
Subcutaneous delivery of daratumumab in Japanese patients with relapsed/refractory multiple myeloma Hirohiko Shibayama1 · Morio Matsumoto2 · Hiroshi Kosugi3 · Kazuhiro Shibayama4 · Hiroshi Yamazaki4 · Shinsuke Iida5 Received: 3 June 2020 / Revised: 29 July 2020 / Accepted: 25 August 2020 © Japanese Society of Hematology 2020
Abstract Subcutaneous daratumumab (DARA SC; daratumumab co-formulated with recombinant human hyaluronidase PH20) is administered in ~ 5 min and demonstrates safety and efficacy comparable to intravenous daratumumab, with low infusionrelated reaction (IRR) rates in global populations. This open-label, multicenter, phase 1 study is the first evaluation of DARA SC in Japanese patients. Eligible patients had relapsed/refractory multiple myeloma (RRMM; ≥ 2 prior lines of therapy including a proteasome inhibitor and immunomodulatory drug). Patients (N = 6) received DARA SC 1,800 mg until progression (weekly for Cycles 1–2; every 2 weeks for Cycles 3–7; monthly for Cycles 7 + [28-day cycles]). The primary objective was to evaluate safety. Secondary objectives included efficacy and pharmacokinetics. Median time of administration was 3–4 min for all injections. No dose-limiting toxicity occurred, and no treatment-emergent adverse events were serious or led to discontinuation. No IRRs were observed; 4 (67%) patients had injection-site reactions (all grade 1). Overall response rate was 67%. Pharmacokinetics of DARA SC in Japanese patients were similar to findings from the global phase 1b PAVO study (NCT02519452). DARA SC at a flat dose of 1,800 mg was well tolerated in Japanese RRMM patients with comparable efficacy and pharmacokinetics to intravenous daratumumab. ClinicalTrials.gov identifier NCT03242889. Keywords Daratumumab · Subcutaneous · Multiple myeloma
Introduction Previous presentation The data were presented in part, based on an earlier data cut, at the 80th Annual Meeting of the Japanese Society of Hematology in Osaka, Japan, 12–14 October 2018. Department and Institution Where Work Was Done Japanese Red Cross Central Medical Center, Nagoya City University Hospital, Osaka University Hospital, Shibukawa Medical Center, and Ogaki Municipal Hospital. * Hirohiko Shibayama [email protected]‑u.ac.jp 1
Department of Hematology and Oncology, Osaka University Graduate School of Medicine, Osaka, Japan
2
Department of Hematology, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan
3
Department of Hematology, Ogaki Municipal Hospital, Ogaki, Japan
4
Research & Development Division, Janssen Pharmaceutical K.K., Tokyo, Japan
5
Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
In Japan, multiple myeloma (MM) occurs in approximately 5 out of 100,000 people and has a 5-year survival rate of approximately 35% [1, 2]. Although Japan has historically had a lower incidence of MM than Western countries, both the incidence and mortality rate are on the rise [2, 3]. The availability of novel agents, including proteasome inhibi
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