Oncology Highlights - January 2016
Reading our newsletter will only take a few minutes and allows you to keep up to date with last month’s news items on oncology drug development.
Kind regards, the SMS-oncology team
Predicting cancer evolution via laws of nature
A new study published in Nature Genetics reports that the spread of mutations in a cancer follows natural laws and is therefore (in theory) predictable. By analyzing 904 cancers from 14 types and from different cohorts, scientists at The Institute of Cancer Research, London and Queen Mary University of London (QMUL) found that many cancers evolve in patterns. Important cancer genes are already present during the early stages of tumor growth and new mutations in the tumor often have no additional effect. These “passenger” mutations accumulate following the so-called 1/𝑓 power-law distribution, a pattern driving a diversity of physical and chemical processes in nature such as the flow of rivers. These findings indicate that by applying mathematical formulas to tumor biopsies doctors may be able to predict how the cancer will change and grow in time, and what treatments should be used. It also offers opportunities to interpret existing cancer genomic data and to discriminate between functional and non-functional intratumoral heterogeneity. Read more >
Fault in new gene BRIP1 increases ovarian cancer risk
Germline mutations in the BRCA1, BRCA2 and mismatch repair genes are known to be associated with the development of ovarian cancer, and represent a subgroup of approximately 15%. By comparing the genes of 8650 women – either being diagnosed with ovarian cancer, not having cancer, or having a family history of the disease – researchers found that woman carrying a fault in the BRIP1 gene have up to a 3 times higher chance to develop the fifth most common cancer in the UK. These women were also more likely to be diagnosed with an aggressive ovarian cancer at a later stage, as well as at an older age. It was estimated that 1 out of every 1000 woman has a mutated BRIP1, or BRCA1-interacting protein 1 gene. The scientists from the University of Cambridge, UCL and Imperial College London published their study in the Journal of the National Cancer Institute. Read more >
Invention of mini “microscope pen” for real-time cancer cell identification
A groundbreaking invention from the University of Washington, the mini-microscope, has the potential to allow for real-time identification of cancer cells during surgery. The device the size of a pen enables surgeons to see the tissue at cellular level and zoom in to make an accurate distinction between tumor and normal tissue cells. It uses a microelectromechanical system (MEMS)-based line-scanned (LS) dual-axis confocal (DAC) microscope, and especially the dual-axis architecture has advantages in terms of reducing background noise from out-of-focus and multiply scattered light. Offering a quick and noninvasive alternative to gold-standard histopathology, the “microscope pen” may improve early cancer detection and guide tumor-resection procedures, thereby improving patient outcomes. In collaboration with Stanford University, Memorial Sloan Kettering Cancer Center and the Barrow Neurological Institute, the mini-microscope is currently being perfected. The work is published in Biomedical Optics Express. Read more >
Mandatory tissue sampling barrier for trial participation
More and more non-small cell lung cancer (NSCLC) trials mandate tumor tissue specimens and accompanying analyses before patients are eligible for participation. A new study published in the Journal of Thoracic Oncologyhighlights the impact of biopsy requirement on patient enrollment in clinical trials. The team of researchers investigated 55 clinical trials including advanced NSCLC patients of which 38 required tumor samples for enrollment; 6 mandated repeat biopsies, while 32 allowed the use of archival samples. Of the 549 subjects offered to participate, 60% received study treatment. This percentage was higher in trials where tissue sample was not required (83% vs 55%), and patients in these trials also started therapy earlier (after 9 vs 16 days) compared to trials where tissue sample was mandatory. A similar finding was seen when comparing the use of archival tissue vs repeat biopsies. With mandatory tissue sample being a significant barrier for patient enrollment, the investigators from the Princess Margaret Cancer Center in Toronto Potential reported the following potential solutions: use of available diagnostic samples (e.g. cytology samples), development of peripheral blood assays for molecular markers, faster central laboratory testing turnaround time, and more resources for rapid biopsy. Read more >
European biotech sector raised a new record of €6.26 billion in 2015
Despite the declining global biotech boom, 191 listed European biotech companies raised a total of €6.26 billion in 2015 when counting the number and volumes of IPOs, follow-on financings and secondary listings. This is a new record for the European biotech sector and an 82% increase compared to 2014 (€3.44B). One-third of the capital (€2.01B) came in through the US stock market NASDAQ, although the European Euronext and AIM are becoming increasingly more popular trading centers. Of the 25 European biotech that opted for an IPO worth a total of €1.21bn, the top 3 highest were recorded by Adaptimmune (€170M) on NASDAQ, Cassiopea in Zurich (€168M) and Biocartis (€115M) in Brussels. The remaining €5.05bn was obtained via follow-on financings. The key findings are reported by German market analyst BIOCOM AG in their “Analysis of European Biotech Companies on the Stock Markets: US vs Europe”. Read more >
Obama administration launched ‘moonshot’ initiative to cure cancer
President of the US, Obama, announced during his final State of the Union speech to launch a ‘moonshot’ initiative to cure cancer wherein both private and public resources are to be increased. The goal is to bring together the different disciplines in oncology research including all its stakeholders (e.g. government agencies and regulators, academic research institutions, private industry and patient groups) to support and build upon basic science and translate this into improved cancer treatments. The initiative supported by US Biotechnology Innovation Organization (BIO) and the American Association for Cancer Research (AACR) will be led by vice president, Joe Biden, whose son died of brain cancer last year. Read more >
EMA / FDA
EMA drug recommendations for approval January 2016:
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for:
- Empliciti (elotuzumab, Bristol-Myers Squibb) for the treatment of multiple myeloma in combination with lenalidomide and dexamethasone after receiving at least one prior therapy. Empliciti is an immunostimulatory monoclonal antibody targeting the protein SLAMF7 (signalling lymphocyte activation molecule family member 7) that is highly expressed on multiple myeloma cells. Empliciti was designated as an orphan medicinal product in 2012, and was accelerated assessed.
- Revlimid (lenalidomide, Celgene) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The derivative of thalidomide has already been approved for the treatment of multiple myeloma as well as myelodysplastic syndromes (MDS).
The FDA adopted an extension of indication for:
- Halaven (eribulin, Eisai Co.) for the treatment of unresectable or metastatic liposarcoma after receiving a prior anthracycline-containing regimen. Eribulin is a synthetic mesylate salt with unique microtubule inhibitor anticancer effects. The development program for eribulin for this indication received orphan drug designation. Eribulin is already used for the treatment of metastatic breast cancer.
- Arzerra (ofatumumab, Novartis) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). The CD20 targeting antibody was already approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate, as well as for CLL patients who are refractory to fludarabine and alemtuzumab.