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AstraZeneca, Lilly enter clinical trail pact to evaluate safety and efficacy of MEDI4736 in combo with ramucirumab to treat solid tumours
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London, UK
May 30 , 2015
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AstraZeneca and Eli Lilly and Company (Lilly) have entered into a
clinical trial collaboration to evaluate the safety and preliminary
efficacy of AstraZeneca’s investigational anti-PD-L1 immune checkpoint
inhibitor, MEDI4736, in combination with ramucirumab (Cyramza), Lilly’s
VEGF Receptor 2 antiangiogenic cancer medicine. The planned study will
assess the combination as a treatment for patients with advanced solid
tumours.
The phase I study is expected to establish the safety
and a recommended dosing regimen, with the potential to open expansion
cohorts in various tumours of interest, for the combination of MEDI4736
and ramucirumab.
Under the terms of the agreement, the trial
will be sponsored by Lilly. Additional details of the collaboration,
including tumour types to be studied and financial terms, were not
disclosed.
MEDI4736 is a monoclonal antibody developed by
MedImmune, AstraZeneca’s global biologics research and development arm,
directed against programmed cell death ligand 1 (PD-L1). Signals from
PD-L1 help tumours avoid detection by the immune system. Ramucirumab is a
vascular endothelial growth factor (VEGF) Receptor 2 antagonist that
specifically binds and blocks activation of VEGF Receptor 2 by blocking
the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D.
Preclinical data indicate that combining VEGFR inhibitors with immune
checkpoint blockades, such as PD-L1 targeted agents, has the potential
to enhance anti-tumour activity.
Robert Iannone, Head of
Immuno-oncology, Global Medicines Development at AstraZeneca, said: “We
believe that combination therapy in immuno-oncology has the potential to
transform the way cancer is treated. MEDI4736 is supported by a
comprehensive development programme and is emerging as a cornerstone of
our combination-focused immuno-oncology pipeline targeting multiple
tumour types. Our collaboration with Lilly is a great addition to our
programme and provides the opportunity to explore another exciting,
novel combination that could deliver important clinical benefit to
cancer patients.”
“The development of immune checkpoint
inhibitors has been one of the more exciting research advancements in
recent oncology history, but it is going to be even more interesting to
see how these inhibitors can be combined with other proven targeted
therapies,” said Richard Gaynor, M.D., senior vice president, product
development and medical affairs, Lilly Oncology. “This collaboration
represents the next wave of immuno-oncology research by bringing
together two innovative medicines – Lilly’s Cyramza and AstraZeneca’s
MEDI4736 – as a novel combination that we hope will one day provide new
cancer treatment solutions.”
In the EU, ramucirumab has been
granted marketing authorisation for use in adults, in combination with
paclitaxel, for the treatment of advanced gastric or gastro-oesophageal
junction adenocarcinoma following prior chemotherapy, and as a
monotherapy in this setting for patients for whom treatment in
combination with paclitaxel is not appropriate.
Ramucirumab
is approved in the US for use as a single agent or in combination with
paclitaxel as a treatment for people with advanced or metastatic gastric
(stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose
cancer has progressed on or after prior fluoropyrimidine- or
platinum-containing chemotherapy. It is also approved in the US in
combination with docetaxel as a treatment for people with metastatic
non-small cell lung cancer (NSCLC) whose cancer has progressed on or
after platinum-based chemotherapy. Additionally, it is approved in the
US with FOLFIRI as a treatment for people with metastatic colorectal
cancer (mCRC) whose cancer has progressed on or after therapy with
bevacizumab, oxaliplatin, and a fluoropyrimidine.
MEDI4736 is an
investigational human monoclonal antibody directed against programmed
cell death ligand 1 (PD-L1). Signals from PD-L1 help tumours avoid
detection by the immune system. MEDI4736 blocks these signals,
countering the tumour’s immune-evading tactics.
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