Oncology Highlights - January 2017
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
New method for prostate cancer screening might prevent thousands of biopsies
A new study led by the University College London (UCL) showed the possibility to use MRI scans to catch and diagnose prostate cancer, a method which could make biopsies unneeded. Next to causing side effects such as bleeding, pain and infections, biopsies have a higher chance to miss the tumour at all. Trial results on 576 men demonstrate that the MRI scan could pick up 93% of the aggressive cancers, against a rate of only 48% by biopsies. In the UK only, 100,000-120,000 men are sent for a biopsy annually after initial blood tests suggest prostate cancer, while the new MRI scans showed that more than a quarter could have been spared from the procedure. With the current diagnostic systems being limited, these new findings were described as “the biggest leap forward in prostate cancer diagnosis in decades”. However, big obstacles remain: both the high costs of the scan as the availability of the scanners itself could be drawbacks to implement this technique on a higher scale. The paired validating confirmatory study was published in The Lancet.
“Off the shelf” CAR T cells possibly cured leukemia in babies
Doctors from London’s Great Ormond Street hospital might have cured two babies of leukemia. The little patients received chimeric antigen receptor (CAR) T cells created from a donor’s blood instead of their own. Normally, CAR T cells are custom-made from a patient’s own blood, which is not always possible for example when the patient does not have sufficient healthy T cells. With the new development, CAR T cells from donor blood are “upgraded” using gene editing to disrupt TCR and CD52. The still functional CAR T cells now can evade host immunity in unmatched recipients. With these additions, cells can be harvested and stored ahead of time instead of the costly and timely process of manufacturing the patient its own cells. These “off the shelf” donor CAR T cells can be used to create many doses of cancer treatments, overcoming both the hindering costs and time problems. However very promising, extensive clinical testing to confirm the technique’s efficacy is required. The report was published in Science.
Novel imaging technique to follow T cells in immunotherapy
A novel technique demonstrated a new way to visualize and monitor the behaviour of immunotherapy cells. With this imaging technique, researchers are able to see where T cells attach, how many arrive in the tumor, or if the cells even remain alive, which can help clinicians in the future to learn if and why a treatment works or doesn’t work in a cancer patient. This is the first demonstration of non-invasively imaging of the immune system in action. Currently, evaluating patient’s remission and thus efficacy of a therapy is based on tumor shrinkage which can take months – no tools are available to see whether treatment is working during the therapy – and can lead to ‘pseudo progression’ in which immune cells infiltrating a tumor and doing their job are falsely mistaken for tumor growth and progressive disease (PD). The T cells used in this imaging technique have an added ‘reporter gene’ that produces a protein visible using PET scan. Imaging can be performed weeks to months later again, which could provide clinicians with timelines of T cell behaviour. The research group is now working on perfecting this technique by trying if the T cells could be imaged when they are actually attached to the tumor cells. The novel imaging technique was reported in Science.
Refined view of esophageal cancer and treatment strategy
By collecting samples of esophageal and gastric cancer from patients around the world, scientists from the Dana-Farber Cancer Institute have found data suggesting that there are two separate types of esophageal cancer. While the upper esophageal cancers closely resemble cancers in the head and neck, tumors further down are very similar to stomach cancer. It was shown that the clinical subtypes differ profoundly at the molecular level, and are different in such a way that it suggests they should be considered as separate diseases. Currently, 4 out of 5 patients die of esophageal cancer within 5 years of diagnosis. With this refined view of the disease, oncologists are likely to change their approach to studies and treatment. The study carried out by The Cancer Genome Atlas (TCGA) Research Network was published in Nature.
“While a lump is the most common sign of breast cancer, some symptoms can be seen rather than felt.” The new awareness campaign #KnowYourLemons uses lemons to show women the symptoms of breast cancer and urges them to see a doctor if they notice any of the 12 changes in their breasts. The campaign is a reminder that lumps are not the only symptom of breast cancer and was designed by Corrine Beaumont, as she felt that the woman displayed in the current campaigns do not look like ordinary woman. Moreover, she states, even those with little literacy can understand this image. The campaign is estimated to be already seen by over 7.5 million people.
Takeda acquires Ariad Pharmaceuticals
Takeda Pharmaceuticals announced to have entered into agreement to acquire Ariad Pharmaceuticals, paying $24 per share that equals a total value of approximately $5.2 billion. The Japan-based company has been looking for new drugs to refill their pipeline, as some of their biggest products’ patents have expired. This take-over includes an expansion of Takeda’s portfolio with Iclusig® (ponatinib) and brigatinib (previously known as AP26113). For the latter, the FDA has granted priority review to its new drug application (NDA) for the treatment of ALK-positive non-small cell lung cancer (NSCLC) and is expected to be approved shortly. It is regarded to be a potential best-in-class ALK inhibitor with peak sales over $1 billion. Ponatinib is an oral drug developed by ARIAD Pharmaceuticals for the treatment of chronic myeloid leukemia and Philadelphia chromosome–positive acute lymphoblastic leukemia. It is a multi-targeted tyrosine-kinase inhibitor. The commercially available tyrosine kinase inhibitor Iclusig® was in the news in October 2016, when Senator Bernie Sanders expressed his disapproval about Ariad’s so-called “greed” when setting the price of the drug at almost $200,000 a year.
EMA / FDA
Both the EMA and the FDA have not announced any approvals or recommendations for new oncology drugs in January 2017.
ICH publishes renovation plan for ICH E6 and E8
This month, ICH proposed improvements to the clinical trials guidelines ICH E8 and E6 as a response to an open letter sent to the EMA and ICH in February 2016. Research organizations and an international consortium of health researchers expressed their concerns regarding to the guidelines failing to ‘sufficiently recognize variations in the level of risk for participants in the different types of trials and allow corresponding flexibility in managing risks’. Moreover, it was said that good clinical practice guidelines should address the planning and the conduct of clinical trials more as a whole and not as separate parts. ICH now responded with a paper highlighting several aspects of the discussions, concluding in a proposed plan for renovation related to clinical trial design, planning, management, and conduct that expands on the important work of ICH E6 R2.