Receive our newsletter – data, insights and analysis delivered to you
  1. News
December 13, 2016

MorphoSys begins Phase II COSMOS trial of MOR208 combined with idelalisib to treat CLL or SLL

German biotechnology company MorphoSys has initiated its Phase II COSMOS trial of MOR208 combined with idelalisib (Zydelig) to treat adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

German biotechnology company MorphoSys has initiated its Phase II COSMOS trial of MOR208 combined with idelalisib (Zydelig) to treat adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

MOR208 is an investigational Fc-engineered monoclonal antibody targeting CD19.

Fc-modification of MOR208 results in potentiation of antibody-dependent, cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), which is believed to improve a key mechanism of tumour cell killing.

MOR208 binds to CD19, which is broadly and homogeneously expressed across different B-cell malignancies, including DLBCL and CLL, thereby inducing direct apoptosis.

Idelalisib selectively inhibits phosphatidylinositol 3-kinase p110δ for CLL.

The Phase II CLL patients assessed for ORR & Safety in MOR208 Study (COSMOS) is being conducted as a single-arm, open-label, multicentre trial, which will include patients in Europe and the US who will receive intravenous infusions of MOR208 for up to 24 cycles of 28 days each and oral administration of Idelalisib on a twice-daily basis.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
"We look forward to exploring the potential of MOR208 in this indication in combination with idelalisib."

MorphoSys chief development officer Dr Arndt Schottelius said: "There is a particularly high medical need for chronic lymphocytic leukaemia (CLL) patients, especially following discontinuation of a BTK inhibitor therapy.

“We look forward to exploring the potential of MOR208 in this indication in combination with idelalisib.”

The study is primarily focused on determining the overall response rate (ORR), as well as comprising complete responses (CR) and partial responses (PR) resulted by the MOR208 and Idelalisib combination.

The secondary endpoints of the study are to assess progression-free survival (PFS), overall survival (OS) and duration of response (DoR), evaluation of the drug combination's safety and determination of pharmacokinetic parameters of MOR208.

MOR208 is currently being tested as an immunotherapeutic treatment option within several phase II combination studies in patients with B-cell malignancies, while another Phase II Lenalidomide-MOR208 IN DLBCL (L-MIND) study is testing the safety and efficacy of MOR208 in combination with lenalidomide to treat relapsed or refractory DLBCL.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU