Oncology Highlights - August 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
Natural selection reason for difference between common and rare cancer types
A new study published in Trends in cancer have now found a possible reason why some cancers are common, while others are rare. The researchers propose that large or paired organs, such as the colon or breast, are more vulnerable for developing malignant tumors than the critical organs important to keeping you alive and for reproduction, such as the heart, brain or uterus. The latter organs may have evolved fewer mechanisms to defend against cancerous cells as a result of natural selection. The evolution theory now may be an explanation for the difference in rates of organ cancer in addition to external risk factors (e.g. smoking or UV light exposure) and internal factors (e.g. frequency of cell divisions in an organ). Another suggestion by the team was to regard individual organs as specialized islands with their own environmental conditions in terms of the level of oxygen, acidity and water, as cancer cell survival most likely depends on the hospitality of the local environment. A complete analysis of the influence of the ecological factors on malignancy will now be carried out by the researchers.
Exaggerated long-term effects of Hiroshima and Nagasaki?
This month’s publication in the journal Genetics indicates that the long-term effects of the atomic bombs over the Japanese cities Hiroshima and Nagasaki back in 1945 may have been exaggerated. This was concluded by Dr. Jordan who re-analyzed data collected in the past 60 years, obtained currently by the group the Radiation Effects Research Foundation (RERF). This dedicated research group funded by the Japanese and American governments collected data of 100.000 survivors, 77.000 of their offspring, and 20.000 controls who were not exposed to radiation. Dr. Jordan summarizes that cancer rates among the survivors was higher compared to those who were out of town at the time and that the risk increased with age (younger people facing a greater lifetime risk), sex (woman are of higher risk than men) and the detonation site distance. Because most survivors only had a modest exposure to radiation, many did not develop cancer and the overall incidence was only 10% higher. Nevertheless, people exposed to a high radiation dose of 1 Gray – exceeding current safety limits with approximately 1000 times – showed a 44% increase of cancer risk over the same time span (1958-1998). The overall reduction of lifespan due to the atomic bombs was indicated to be “just” 1.3 years.
Transmissible cancer DFTD resistance in evolved Tasmanian devils
One of the only three known forms of transmissible cancer types that recently emerged on Tasmanian devils – devil facial tumour disease (DFTD) – is also the deadliest form, having killed already more than 80% of this large carnivorous animal species in Australia. However, a new study published in Nature Communications suggests that some populations evolve genetic resistance to DFTD, which may avoid the species’ extinction. By comparing the DNA of Tasmanian devils from both before and after the DFTD outbreak 20 years ago, Prof. Storfer and colleagues from Washington State University identified two small genomic regions in the DNA samples that showed significant changes indicative of DFTD resistant DNA. This shows a rapid evolutionary response to strong selection and suggests hope for the species’ survival. In addition, it may “also help direct future research addressing important questions about the evolution of cancer transmissibility and what causes remission and reoccurrence in cancer and other diseases" concluded Prof. Storfer.
Cancer overtakes heart disease as leading killer in 12 European countries
Cardiovascular disease (CVD) is the main cause of death worldwide with a global burden of 17.3 million deaths, however European Heart Journal recently published that cancer has now overtaken CVD as leading killer in 12 European countries. Here it was found that in Europe CVD caused more than 4 million deaths each year, a number that significantly decreased due to preventing and treating strategies. As a result, now more men die from cancer than CVD in the following 12 countries: The Netherlands, Belgium, Norway, France, Italy, Luxembourg, Portugal, Slovenia, Spain, the UK, Denmark and Israel. In the latter two countries it accounts for both men and woman. The trend was observed first in France. Nevertheless, on a global scale, cancer caused 8.2 million deaths in 2013, which is less than half caused by CVD.
A healthy Tasmanian devil
Pfizer to buy Medivation for $14B
Pfizer has completed negotiations and months of bidding for the takeover of San Francisco’s most desired independent biotech company Medivation, in a cash deal worth about $14 billion. In that way, Pfizer acquired a leading prostate-cancer drug Xtandi to boost its oncology portfolio. According to market analysts, Medivation’s drug creates around $2 billion gross sales per year and has the potential to more than double. It was reported earlier that besides Pfizer, Sanofi, Merck & Co, Celgene and Gilead Sciences had submitted expressions of interest to acquire Medivation. The strong interest in Medivation illustrates the high need for new effective cancer treatments and, the potential guaranteed billions of dollars in turnover to the companies that own them.
EMA / FDA
EMA oncology drug recommendations for approval August 2016:
No Committee for Medicinal Products for Human Use (CHMP) meeting was held in August.
FDA oncology/hematology approvals in August 2016:
The FDA granted accelerated approval to:
- Pembrolizumab (Keytruda, Merck Sharp & Dohme) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The approval of the PD1 inhibitor was based on demonstration of a durable objective response rate (ORR) in a subgroup of patients in a non-randomized study. As a condition of the accelerated approval, Merck needs to conduct a multicenter, randomized trial to show the clinical benefit and superiority of pembrolizumab over standard of care. In line with this, Merck's KEYNOTE 040 trial is ongoing. Keytruda is already approved for the indications NSCLC and melanoma.
UK regulator updates guidance for medical devices including apps
The number of health apps claiming to help manage health including ones that gather, analyze and interpret data for diagnosis, treatment recommendations or prescriptions exploded in this growing digital world. A new guidance was offered by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) to help identify the health apps which are medical devices and make sure they comply with regulations and are acceptably safe. In the UK, as in the rest of Europe, software and apps declared as “regulated and acceptably safe” medical devices gain a CE mark in line with the EU medical device directives. MHRA hopes to help with the classification process by releasing the step-by-step interactive PDF guidance document.