Dr-Nancy Valente

Phase I Study T-cell Bispecific Antibody For Aggressive Non-Hodgkin’s Lymphoma

MedicalResearch.com Interview with:

Dr-Nancy Valente

Nancy Valente, M.D.,
Vice President, Global Hematology Development

MedicalResearch.com:  What is the background for this study?

Response: Despite advances in treatments for people with relapsed or refractory (R/R) NHL, a substantial number of patients do not sustain a response to standard-of-care treatment, meaning new options are needed. For example, as many as 40 percent of people with diffuse largeB-cell lymphoma (DLBCL), an aggressive form of NHL, eventually relapse after initial treatment. Different mechanisms of action and different therapy combinations may help improve clinical outcomes in patients with R/R NHL.

At ASH, we presented initial safety and efficacy results from a Phase I study of our T-cell bispecific antibody, CD20-TCB, as a monotherapy in patients with R/RNHL.

MedicalResearch.com: What are the main findings?

Response: The preliminary results suggest thatCD20-TCB monotherapy have promising clinical activity and may induce durable complete responses in patients with late-line R/R aggressive NHL. In patients with aggressive NHL who received the highest tested dose roughly half (53 percent) of patients responded (objective response rate)to treatment and nearly a third (27 percent) saw the disappearance of all signs of cancer (complete response). Importantly, all complete responses have been sustained so far, with a median follow up of roughly three months (94 days). These responses are particularly encouraging since aggressive forms of NHL become harder to treat with each relapse.

Patient sin the study had previously received a median of three lines of therapy, with a range of 1-13 lines. Most were refractory to their most recent therapy (72percent) and refractory to prior treatment with an anti-CD20 antibody (74percent).

MedicalResearch.com: What should readers take away from your report?

Response: CD20-TCB is one of two bispecific antibodies we are developing that are designed to target CD20 and CD3. At ASH, we also presented data for mosunetuzumab. The results from the first clinical trials of these bispecific antibodies showed promising clinical activity and durable complete responses inpatients with R/R NHL. We are excited by the potential to harness the dual-targeting ability of CD20-CD3 bispecific antibodies to treat blood cancers and encouraged by these early results. We continue to study CD20-TCB and mosunetuzumab as potential new treatment options for patients with R/R NHL, an area of high unmet need.

MedicalResearch.com: What recommendations do you have for future research as a result of this work?

Response: Bispecific antibodies can recognize and bind to two different targets simultaneously, and in doing so, combine the binding specificity of two antibodies in one molecule. In the treatment of cancer, bispecific antibodies are designed to physically link a cancer cell to an immune cell which leads to the destruction of the cancer cell by the patient’s immune system, representing a novel approach for the treatment of cancers.

CD20-Tcb (RG6026), a Novel “2:1” FormatT-Cell-Engaging Bispecific Antibody, Induces Complete Remissions inRelapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma: Preliminary Results from aPhase I First in Human Trial

ASH 2018, December 1, 2018: 4:45 PM

MartinHutchings, MD, PhD1*,Gloria Iacoboni, MD2*, Franck Morschhauser,MD3*, Fritz Offner, MD4, AnnaSureda, MD5*, Gilles Andre Salles, MD, PhD6,Carmelo Carlo-Stella, MD7,Joaquin Martinez Lopez, MD8*,Denise Thomas, BS9*, Peter N Morcos, PhD10*, BetsyQuackenbush, MD9*, Cristiano Ferlini, MD11*,Marina Bacac, PhD12*, Ann-Marie E. Broeske,PhD13*, Natalie Dimier, PhD14*, TomMoore, MD11*, Martin Weisser, MD15* andMichael Dickinson, MBBS, FRACP, FRCPA16


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Last Updated on December 11, 2018 by Marie Benz MD FAAD