Sanofi's CD38 Antibody Sarclisa Combination Therapy Meets Primary Endpoint in Phase 3 IKEMA Trial for Multiple Myeloma

Today, Sanofi announced that Sarclisa (isatuximab-irfc), its CD38 antibody, in combination with dexamethasone and carfilzomib, met the primary endpoint in the interim analysis of the Phase 3 IKEMA clinical trial in patients with multiple myeloma (MM). Compared with treatment with dexamethasone and carfilzomib alone, the isatuximab-containing combination therapy significantly reduced the risk of disease progression or death. These positive data from the trial will support the submission of regulatory applications for isatuximab.

Multiple myeloma (MM) is a hematologic malignancy caused by the malignant transformation of plasma cells in the bone marrow. Abnormal plasma cells accumulate in the bone marrow, forming tumors in multiple bones throughout the body. These cells not only fail to perform their normal functions but also impair the bone marrow’s ability to produce healthy blood cells. Malignant plasma cells disrupt normal hematopoiesis, leading to decreased blood cell counts, bone damage, and renal impairment. Despite significant advances in the treatment of MM in recent years, the majority of patients still face the challenges of relapse or drug resistance, which pose life-threatening risks.

Isatuximab is a monoclonal antibody targeting the CD38 receptor on the surface of plasma cells, which can trigger multiple distinct mechanisms of action to promote apoptosis and modulate immune responses. In March this year, the U.S. FDA announced the approval of isatuximab in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.

The IKEMA study is a randomized, multicenter, open-label Phase 3 clinical trial designed to evaluate the efficacy and safety of adding isatuximab to current standard-of-care regimens for multiple myeloma (MM). All patients enrolled in the trial had received one to three prior lines of therapy. The primary endpoint was progression-free survival. Secondary endpoints included overall response rate, overall survival, and safety profiles. The positive results of this study will be presented at future academic conferences.

“The results of this Phase 3 clinical trial demonstrate that adding isatuximab to the standard treatment regimen of carfilzomib and dexamethasone significantly reduces the risk of disease progression or death in patients,” said John Reed, M.D., Global Head of Research and Development at Sanofi. “This marks the second set of positive Phase 3 clinical trial data for isatuximab, further supporting the therapeutic potential of our drug in improving outcomes for patients with relapsed multiple myeloma.”

According to the latest public announcements on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration, two new clinical trial applications for isatuximab injection have been submitted in China. As recorded on the Chinese Clinical Trial Registry and Information Publicity Platform, Sanofi is conducting two clinical trials in patients with multiple myeloma. One is a randomized, open-label, international, multicenter Phase 3 study designed to compare the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone versus bortezomib, lenalidomide, and dexamethasone alone in prolonging progression-free survival in patients with newly diagnosed multiple myeloma who are ineligible for transplantation. The other is a Phase 1 clinical study aimed at evaluating the pharmacokinetics, safety, and preliminary efficacy of isatuximab in Chinese patients with relapsed/refractory multiple myeloma.

Image source: CDE official website

References:

[1] Sarclisa® (isatuximab) Phase 3 IKEMA trial meets primary endpoint early in patients with relapsed multiple myeloma. Retrieved 2020-05-12, from https://www.sanofi.com/en/media-room/press-releases/2020/2020-05-12-07-00-00

Original Title: Sanofi’s CD38 Antibody Combination Therapy Meets Phase 3 Clinical Endpoints; Clinical Trial Application Submitted in China

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