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December 8, 2017

Sanofi starts Phase lll trials of isatuximab combination for cancer

Sanofi has initiated two Phase lll trials of is atuximab in combination with other cancer treatments in patients with multiple myeloma, a rare blood cancer related to lymphoma and leukemia.

Sanofi has started two Phase lll trials of is atuximab in combination with other cancer treatments in patients with multiple myeloma, a rare blood cancer related to lymphoma and leukemia.

The late-stage clinical studies are named IKEMA and IMROZ and include a total of around 750 patients.

IKEMA is a randomised, open-label, global multicentre Phase lll trial that includes 325 patients.

It will compare the combination of is atuximab with carfilzomib and dexamethasone against carfilzomib and dexamethasone in patients with relapsed and refractory multiple myeloma that have previously been treated with one-to-three lines of therapy.

The IMROZ trial includes 425 patients in a randomised, open-label, global multicentre scenario.

The trial will compare atuximab in combination with bortezomib, lenalidomide and dexamethasone, against bortezomib, lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients who are not eligible for transplant.

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“Our multi-study programme aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens.”

Both trials will examine progression-free survival as the primary endpoint, while their key secondary endpoints will cover overall survival and response rate, depth of response, safety and quality of life.

Sanofi Oncology Development head Joanne Lager said: “The start of two new Phase lll trials will provide further clinical data as we continue to advance the development of isatuximab.

“Our multi-study programme across major multiple myeloma segments aims to demonstrate the value of isatuximab in combination with emerging standard treatment regimens.”

Isatuximab is an investigational anti-CD38 monoclonal antibody currently undergoing study for the treatment of relapsed and previously untreated multiple myeloma patients.

In December last year, Sanofi began an additional Phase lll study, ICARIA, comparing isatuximab in combination with pomalidomide and dexamethasone against pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma.

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