ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Please note that you are viewing an archived section from 2022 and some content may be unavailable. To unlock all content for 2022, please visit the archives.

Abstract: SA-PO679

Safety and Efficacy of Felzartamab (MOR202) in Anti-Phospholipase A2 Receptor (PLA2R) Autoantibody-Positive Membranous Nephropathy: The M-PLACE Study

Session Information

Category: Glomerular Diseases

  • 1303 Glomerular Diseases: Clinical‚ Outcomes‚ and Trials

Authors

  • Rovin, Brad H., The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Ronco, Pierre M., Sorbonne Université and INSERM UMRS 1155, Paris, France
  • Wetzels, Jack F., Radboud University Medical Center, Nijmegen, Netherlands
  • Adler, Sharon G., Lundquist Research Institute at Harbor UCLA, Torrance, California, United States
  • Ayoub, Isabelle, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Zaoui, Philippe, Centre Hospitalier Universitaire Grenoble Alpes, Grenoble, Auvergne-Rhône-Alpes , France
  • Han, Seung Hyeok, Yonsei University College of Medicine, Seoul, Korea (the Republic of)
  • Jauch-Lembach, Julia, MorphoSys AG, Planegg, Germany
  • Faulhaber, Nicola, MorphoSys AG, Planegg, Germany
  • Cui, Jie, MorphoSys US Inc., Boston, Massachusetts, United States
  • Haertle, Stefan, MorphoSys AG, Planegg, Germany
  • Sprangers, Ben, University Hospitals Leuven, Leuven, Belgium
Background

Primary membranous nephropathy (MN) is an autoimmune kidney disease. Depleting CD20−/CD38+ plasma cells, potentially a main source of autoantibodies, may be an effective treatment (Tx) strategy for MN, particularly in patients (pts) with high PLA2R Ab titers. This interim analysis reports proof-of-mechanism data for felzartamab, a fully human IgG1 anti-CD38 mAb.

Methods

M-PLACE (NCT04145440) is a Phase Ib/IIa, open-label, multicenter, multinational study of adults with anti-PLA2R Abs-associated MN requiring immunosuppressive therapy (IST). Cohort 1: newly diagnosed and IST-relapsed pts; Cohort 2: IST-refractory pts. Pts received 9 felzartamab infusions (16 mg/kg) over six 28-day cycles, followed by a 28-week follow-up. Primary endpoints are incidence and severity of Tx-emergent adverse events (TEAEs); key secondary endpoint is the immunologic response rate based on anti-PLA2R Ab reductions; exploratory endpoints include the effect of Tx on 24h UPCR reduction.

Results

By April 10, 2022, 31 pts were enrolled from 21 sites in N. America, Asia-Pacific, and Europe (Cohort 1, n=18; Cohort 2, n=13); 23 pts have completed the Tx phase (Cohort 2, n=9). Mean (SD) age was 57.5 (11.8) years and 77.4% were male. At baseline, mean circulating anti-PLA2R Ab titer was 247.1 (259.3) U/mL; mean UPCR was 6.4 (2.2) g/g; mean eGFR was 60.2 (20.0) mL/min/1.73m2. Overall, 27 pts (87%) had at least one TEAE; TEAEs were mostly mild/moderate in severity and the majority resolved. The most commonly reported TEAE was infusion-related reaction (29% of pts; one Grade 3). Five pts (16%) experienced serious TEAEs. A ≥50% reduction in anti-PLA2R Ab titer from baseline was shown in 26/31 pts (84%). Change in anti-PLA2R Ab titer was generally followed by a timely change in UPCR. At ~12 months, 4/12 pts with EOS data showed >50% reduction in UPCR, including one refractory pt.

Conclusion

Longer follow-up of the M-PLACE study shows safety data consistent with the safety profile previously described and as expected in this underlying population. The early and pronounced anti-PLA2R Ab responses observed with felzartamab are encouraging, including in hard-to-treat patients; long-term UPCR responses will be further evaluated.

Funding

  • Commercial Support –