653. Myeloma: Therapy, excluding Transplantation: Immunotherapy in Myeloma and Amyloid
Adam D. Cohen, MD1, Alfred L. Garfall, MD1, Edward A. Stadtmauer, MD, FACP1*, Simon F Lacey, PhD, BS2, et al.
The authors of the study conclude that:
CART-BCMA infusions following Cy lymphodepletion are feasible and have significant clinical activity in highly-refractory MM pts with poor-risk genetics and limited treatment options. Efficacy appears lower at the 107 dose, compared with 108, and remaining pts are now being enrolled in Cohort 3. CRS remains a common but manageable toxicity. Decreased BCMA expression on residual MM cells post-infusion may be an escape mechanism reflecting CART-BCMA-induced immune editing. These data provide further support for exploration of CART-BCMA in relapsed/refractory MM, with updated cohort 3 data to be presented at the meeting.
Lingzhi Yan1*, Jingjing Shang1*, Liqing Kang2*, Xiaolan Shi1*, et al.
The authors of the study conclude that:
Combined administration of auto/allo-logous CART-19 and CART-BCMA cells can be manufactured from heavily-pretreated MM pts, and demonstrate promising in vivo expansion and clinical activity. Toxicities to date can be controlled and reversed, without TRM. Expanded accrual in cohort 1 is ongoing, with updated data to be presented at the meeting.
Vaishali Sanchorawala, MD1, Shayna Sarosiek, MD2, John Mark Sloan, MD1, Dina Brauneis, NP1*, et al.
The authors of the study conclude that:
Daratumumab infusion is well tolerated in patients with relapsed AL amyloidosis, when administered with appropriate pre and post-medications. Infusion related reactions were minimal and not comparable to reported incidence in myeloma. Preliminary data suggest a rapid hematologic response after 1 dose of daratumumab in patients with AL amyloidosis.
Murielle Roussel1*, Anne-Marie Stoppa, MD2, Aurore Perrot, MD3*, Lionel Karlin, MD4*, et al.
The authors of the study conclude that:
Daratumumab demonstrates encouraging efficacy in previously-treated patients with AL amyloidosis with deep and rapid responses. The administration of DARA in these patients is associated with a good safety profile and non-severe adverse events mostly after the first infusion. Further studies on DARA-based associations in AL amyloidosis patients are warranted. The data will be updated at the meeting.
Camille Vanessa Edwards, MBBS, BSc1*, Julia Gould, BA2*, Arielle L Langer, MD, MPH3*, Markus Y Mapara, MD, PhD4, et al.
The authors of the study conclude that:
We found that mAb 11-1F4 is well tolerated and safe without grade 4 or 5 AEs nor dose limiting toxicity (MTD of 500mg/m2). Moreover, we postulate that in patients with persistent organ dysfunction after plasma-cell directed therapy; mAb 11-1F4 leads to fast, early and sustained organ response. Overall, amyloid fibril targeted therapy with mAb 11-1F4 represents both a promising and innovative approach to the management of patients with AL Amyloidosis. The rapid destruction of amyloid fibrils by mAb 11-1F4 can improve organ function and, potentially improve mortality in patients with this uniformly fatal disease. Larger randomized trials to evaluate the efficacy of this mAb are planned.
Craig C Hofmeister, MD1, Ajai Chari2*, Yael Cohen3*, Andrew Spencer, MD4, et al.
The authors of the study conclude that:
DARA was well tolerated in SMM, with a safety profile similar to that in RRMM. Follow up for efficacy is ongoing. A phase 3 study (SMM3001) is planned to evaluate long intense dosing with subcutaneous administration of DARA in high-risk SMM pts.