Oncology Highlights - May 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!
The SMS-oncology team
First drug approved based on genetics rather than location
For the first time ever, the US Food and Drug Administration has granted approval for the treatment of cancers with a specific genetic feature instead of the location in the body where the tumor originated. Pembrolizumab (Keytruda, Merck) gained accelerated approval for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified with the biomarker microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). These traits are most common in colorectal, endometrial and gastrointestinal cancers, but may also appear in cancers of the breast, prostate, bladder and thyroid gland. With the recent developments, Merck shares rose with 0.8 percent to $64.55 per share.
Unexpected correlation between diabetes and glioma
An unexpected link between diabetes and glioma has been found. Having higher blood sugar levels often is linked to higher risk of developing cancer, which is known for the colon, breasts and bladder. A new study has now shown that in brain cancers such as glioma the opposite is happening: gliomas are less common in people with higher blood sugar or diabetes. The study team analyzed data on the relation between glioma and diabetes in almost 800 thousand participants. Results showed – next to the negative correlation – that this link was the strongest in the year leading up to the diagnosis. The mechanism behind it is now investigated. The team has some hypotheses: it might have to do with that the recurrence of glioma is related to insulin-like growth factor, which is much lower in people with diabetes, or the extremely high uptake of glucose by the brain might be involved. Further studies should answer the remaining questions, and to see if this correlation can be used to develop new treatments for brain cancer. The results have been published in Nature.
New opportunities for early prediction of immunotherapy response
Checkpoint inhibitors and other immunotherapies have revolutionized cancer treatment the last few years. Unfortunately, these therapies only work in a minority of the patients. Identifying the non-responsive patients earlier could make a great difference, for which an appropriate imaging technique is needed. Traditional imaging techniques measure tumor size. This does not fit to immunotherapy, as it does not distinguish between a nonresponding tumor and a tumor which grows in size as the immune cells infiltrate the tumor (“pseudo progression”). Researchers from the Massachusetts General Hospital in Boston have developed a noninvasive PET imaging method that measures granzyme B. This protein is released by immune cells in order to attack cancer cells. Using granzyme B as a marker, the response of the immunotherapy can better predicted much better at a very early time after starting treatment. This means the patient does not have to endure unneeded side effects and can start sooner with alternative therapies. The results have been published in Cancer Research.
A small change that can prevent a deadly medical error in thousands of patients
Many chemotherapeutics are administered intrathecal, meaning it is injected in the spinal fluid. Incorrect administration can lead to ascending paralysis, neurological defects and death. Oncology nurses might have found a way to overcome this hurdle by simply changing its administration. Instead of intravenous (IV) administration, they advise to dilute them into mini-IV drip bags. This precaution makes it impossible to administer the medication incorrect into the spinal fluid and greatly decreases the chances of improper dosage. So far, this technique was not used, as it was believed this would lead to extravasation. However, testing with over 1300 IV mini-bag administrations zero cases of extravasation were found. Results are now presented at an oncology conference and campaigned to increase awareness.
$360 million for blood test to track and detect cancer
Guardant Health has raised $360 million to deploy its blood tests to 1 million people in the next 5 years. This additional money brings the total budget to $550 million. The biotechnology company from California developed the test to track cancer and potentially detect it. The blood test uses DNA sequencing from bits of DNA shed by a tumor into the blood stream. In 2014, Guardant’s tests have been given to 40,000 people and is raising these numbers to increase access as well as to collect more data. The money and upscaling is an important step for Guardant, as its biggest competitor Illumina raised $900 million to start clinical trials with 100,000 patients using DNA sequencing to screen for breast cancer. Guardant’s goal is to create an annual blood test to detect cancer in its earliest phase when it is most curable.
EMA / FDA
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for:
- Three biosimilars of Mabthera: Blitzima and Tuxella for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukaemia (CLL), and Ritemvia for the treatment of NHL alone. The CD20 monoclonal antibodies are developed Celltrion Healthcare Hungary.
The Food and Drug Administration granted approval for:
- Pembrolizumab (Keytruda, Merck) for the following 3 indications:
- for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have the biomarker microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
- for the treatment of locally advanced or metastatic urothelial carcinoma for patients who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy
- in combination with pemetrexed and carboplatin for the treatment of previously untreated metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Ceritinib (Zykadia, Novartis) for the treatment of metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test. In 2014, ceritinib received accelerated approval for patients with ALK-positive metastatic NSCLC whose disease has progressed or who are intolerant to crizotinib.
- Durvalumab (Imfinzi, AstraZeneca) for the treatment of locally advanced or metastatic urothelial carcinoma, whose disease progressed during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The IgG1κ monoclonal antibody blocks the interaction of PD-L1 with the PD-1 and CD80 molecules.
- Avelumab (Bavencio, EMD Serono) for the treatment of locally advanced or metastatic urothelial carcinoma, whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. The PD-L1 IgG1 monoclonal antibody is already available for the treatment Metastatic Merkel Cell Carcinoma.