MHRA Innovation Passport awarded to Boehringer Ingelheim’s investigational treatment in aggressive and rare cancer
Bracknell, UK, 5 December 2022 – Boehringer Ingelheim announces that investigational compound BI 907828 has received the Innovation Passport from the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of de-differentiated liposarcoma (DDLPS). The Innovation Passport designation represents the first step in the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate the time medicines reach patients to improve access to innovative treatments where there is a significant unmet need.
DDLPS is an aggressive and rare type of cancer that arises in fat tissues.[i],[ii] Commonly seen in middle-aged and older adults, it is estimated that around 66 new patients are diagnosed each year in England.1,[iii] Early and correct diagnosis of DDLPS is often challenging due to the rare nature of the condition and non-specific symptoms.1 The cancer usually presents as a large lump in the back of the abdomen or in the limbs and spreads to other parts of the body in approximately 15-30% of cases; over one quarter (28%) of people with DDLPS die from the disease.1 Existing treatments for advanced or metastatic (disease that has spread) DDLPS are often associated with poor outcomes and significant side effects.[iv],[v],[vi],[vii],[viii]
In early, Phase I clinical testing, BI 907828 demonstrated signs of activity together with a manageable safety profile in a range of advanced solid tumours.[ix] BI 907828 is an oral tablet that works by blocking the interaction between two proteins known as MDM2 and P53 and in doing so it can lead to direct action on tumour cells themselves, and activate the body’s own immune response against the cancer.[x] The global Brightline-1 Phase 2/3 study of BI 907828 in newly diagnosed advanced/metastatic DDLPS is underway with several study sites across the UK and Ireland, including Cambridge, Cardiff, London, Oxford, Sheffield and Dublin.[xi]
“Disappointingly, to date we have seen little progress for people with this type of liposarcoma. Whilst most of the other cancers can see new treatments every few years, there has been no new first-line treatment for this type of liposarcoma for over forty years. The current treatment, which is chemotherapy-based, is often associated with poor outcomes, and patients regularly tell us of their struggles with its debilitating side effects,” said Bradley Price, Policy and Public Affairs Manager at Sarcoma UK. “Any potential new innovative treatment that could extend or improve quality of life would make a significant positive impact to people living with DDLPS and their support networks.”
“At Boehringer Ingelheim, we are committed to transforming cancer care in some of the most challenging areas of cancer research. We are delighted that we have been awarded the Innovation Passport for the clinical development of BI 907828 in DDLPS, where there is a significant unmet need for effective treatment options for people living with this aggressive and rare cancer,” said Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland. “BI 907828 is undergoing an extensive clinical development programme across several cancer indications and is part of our robust pipeline of compounds, including cancer cell-directed and immuno-oncology investigational therapies.”
BI 907828 is an investigational compound (not approved for treatment by any regulatory authorities globally).
