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Amgen unveils double whammy of data for its investigational cancer immunotherapies at ASH 2018

December 07, 2018 By pharmafile
Tag: Amgen , AML , ASH

Amgen has presented the first clinical data at the American Society of Hematology (ASH) Annual Meeting 2018 for two investigational novel bispecific T cell engager (BiTE) immunotherapies, known as AMG 420 and AMG 330. According to the findings, both candidates showed tolerability and anti-tumour activity, with the former in the treatment of relapsed and/or refractory multiple myeloma, and the latter in elapsed or refractory acute myeloid leukaemia (AML).

Amgen describes BiTE technology as “an innovative treatment approach that helps the body's immune system attack cancer cells without the removal of immune cells from the patient.” In the first trial, AMG 420, which acts by targeting B-cell maturation antigens (BCMA), was tested in 42 patients with relapsed and/or refractory multiple myeloma who had progression after at least two prior lines of treatment (including a proteasome inhibitor and an immunomodulatory imide drug).

13 of these patients responded to the therapy, seven of which achieved complete response (CR). In those receiving the 400 µg/d dose, the objective response rate (ORR) was 70%, with six patients still showing response after 7.5 months.

However, 48% of participants experienced serious adverse events (AEs) with 17 requiring hospitalisation, and two died during the course of the study, though Amgen noted that these were not treatment-related.

"These first-in-human data of a BCMA-targeting BiTE immunotherapy showed encouraging evidence of AMG 420 activity, with no major toxicities up to the 400 µg/d dose in patients with relapsed and/or refractory multiple myeloma who received a median of four prior therapies," remarked Dr Max S Topp, Professor at the Hospital of Wuerzburg and AMG 420 clinical study investigator. "Despite recent treatment advances, multiple myeloma continues to be a disease characterised by cycles of relapse and recurrence requiring additional therapies to help control the disease."

In the second trial, AMG 330, which targets CD33, was tested in 40 patients with relapsed or refractory AML in 12 dose cohorts. It was found that two patients achieved CR in the 240 µg/d group, while two achieved CR with incomplete blood count recovery – one in the 240 µg/d group and one in the 120 µg/d group. However, none of these responses were maintained beyond one treatment cycle.

Worrying, 73% of participants experienced severe AEs, with two patients dying over the course of the study – one from AML progression and one from intracranial haemorrhage, neither of which are treatment-related according to the manufacturer.

Dr Farhad Ravandi, the Janiece and Stephen A Lasher Professor of Medicine and Chief of Section of Developmental Therapeutics in the Department of Leukemia at the University of Texas and AMG 330 clinical study investigator, commented on the findings: "The majority of adult AML patients will not be cured with standard chemotherapy, underscoring the need for innovative treatment options for those who have relapsed or are refractory to currently available treatments. These early data are encouraging as they indicate AMG 330 may have anti-leukemic activity in heavily pretreated patients with relapsed or refractory AML, validating the need for continued evaluation of the BiTE platform in targeting CD33.”

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