Our Industry Case Studies
Our industry partnerships are crucial to ensure patients in the UK gain access to innovative treatments at the earliest opportunity. Here are just a few examples of the recent partnerships between our network and industry:
Cambridge ECMC’s Department of Oncology, the Department of Mathematics, and Microsoft Research are collaborating to develop machine learning algorithms to detect both image and non-image features that predict for late toxicity following radiotherapy for head and neck cancer, prostate cancer, lung cancer, and brain tumours.
Autolus (a UCL spinout) secured a £59m investment to take CAR-T cell therapy into blood cancer trials. Two new Phase I/II studies in paediatric acute lymphocytic leukaemia (ALL) and adult diffuse large B-cell lymphoma (DLBCL), AMELIA and ALEXANDER for AUTO3 (an autologous T-cell product, genetically modified to express two separate CARs which recognise CD19 and CD22) have opened at UCL ECMC.
Manchester ECMC was the highest EU recruiter, and performed the molecular profiling in the STARTRK trial, enrolling patients with locally advanced and metastatic solid tumours who had any of a NTRK1, 2, 3 mutation or a ROS1 or ALK gene rearrangement (~1% prevalence). These results have led to Ignyta setting up a trial of registrational intent
A Phase Ib trial with an MPS-1 inhibitor (BOS172722), is now open to recruitment for triple negative breast cancer patients. BOS172722 was initially discovered and developed in the ICR, supported by Cancer Research UK. ICR ECMC is the lead site and lead recruiter for this trial, with its biomarker team providing full pharmacokinetic analysis in this trial.
Leicester ECMC has setup three new haematology partnerships, to run translational studies, with Roche: Obinutuzumab (anti-CD20) antibodies in DLBCL patients; Astex – effect of IAP inhibitors on DLBCL; Bioinvent – expression of CD32b and mechanisms of novel CD32b antibodies in DLBCL.
MiNivAn
The Paediatric Network have further strengthened their partnership with Bristol-Myers Squibb, which has allowed it to complete the Phase I study comparing the use of Nivolumab alone with the combination of Nivolumab and Ipilimumab in high-grade CNS tumours.
This has resulted in Bristol-Myers Squibb providing Nivolumab for the novel MiNivAn combination study, which combines the drug with targeted radiotherapy. Funded by Solving Kids Cancer, the trial opened this year at Southampton and UCH, and has recruited patients with relapsed or refractory neuroblastoma from across the UK.
The 2nd and 3rd phases of this international study will add in the antiGD2 monoclonal antibody Dinutuximab beta to the combination (in collaboration with Eusa).
This Phase I/II study is testing SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), as both a single agent and in combination with Palbociclib in postmenopausal women with ER positive advanced breast cancer. Funded by Sanofi, the trial’s primary endpoints are to determine safe dosage of SAR439859 in both cases.
Dr Rob Jones of Cardiff ECMC was selected as the UK CI for the trial, which is also being run at other ECMC centres including Oxford and Glasgow. This represents one of a number of other commercial studies which are currently still in setup where Cardiff has been selected as the lead UK site with Rob Jones as UK CI.
This study will be assessing patients longitudinally for ctDNA BRAF mutations, with therapy switched to immune therapy if/when the BRAF mutation level reaches a defined threshold making this the first ctDNA primary end-point validated to Good Clinical Practice for clinical decision making.
This therapy switch design is a pioneering approach to offer patients the correct therapy based on their disease development. Run through the Manchester ECMC, the CAcTUS study is driven by CRUK Manchester Institute, The Christie in collaboration with Bristol-Myers Squibb.
Dr Martin Forster and Professor Tony Ng, of UCL ECMC, have established collaboration with Daiichi exploring circulating biomarkers in the Phase II study of DS-8201 in patients with advanced HER2-overexpressing or HER2-mutated non-squamous non-small cell lung cancer.
Phase I of this study was conducted at the Clinical Research Facility (PI Dr Forster) and ECMC supported staff (research nurse, studies manager and data manager) were critical to completing the study, which led to the success of this collaboration.
The translational research involved the use of exosome and immune profiling to identify non-invasive treatment stratification and longitudinal monitoring markers in patients with recurrent / metastatic head and neck cancer.
The study found multivariate risk scores/signatures that predicted either progression free survival or RECIST response. The data was presented at ASCO 2018 (along with the Phase II trial data) and manuscripts are currently being written for publication.