Oncology Highlights - February 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
Barcoding T cells improves current T cell selection
New developments in adoptive T cell transfer, a class of treatments using immune T cells to fight cancer, could have great consequences for the treatment of cancer. Normally, T cells are obtained from the patient or a healthy donor, multiplied in the lab, and returned to the patient. However, each infusion contains thousands of varieties of T cells all with different cancer-killing capabilities, and daughter cells might have different characteristics compared to the mother cell. Fred Hutch scientists are now able to track what happens during adoptive T cell transfers. Based on receptors specific to each T cell, this new method distinguishes different T cells from each other making it possible to track them. By tracking the T cells in patients who went into complete remission, T cells that play the most important role in fighting cancer cells were found to be extremely rare in the body. With this information, those T cells can be selected and increased in population, a process that is now investigated by the research group in clinical trials in lung cancer and acute myloid leukemia (AML) patients. The paper was published in Science.
Blood pressure drug as new cure for angiosarcoma?
Propranolol – a common drug introduced already back in 1964 to treat high blood pressure – received an Orphan Drug Designation by the European Commission (EC) to treat angiosarcoma. Angiosarcoma is an uncommon yet aggressive sub group of the sarcomas. The new application was discovered at the Texas Tech University Health Sciences Center El Paso in 2013. Propranolol was shown to bring tumors down to undetectable levels, with very little to no side effects. Scientists across the world have reported successful results since then, with a surprising 100% clinical response. Being discovered more than half a century ago, propranolol is now available as a generic drug for about $4 a month, compared to current angiosarcoma prescriptions which can cost patients up to $10,000 a month resulting in a full treatment of $100,000 to $200,000. The non-profit Anticancer Fund applied the drug to be approved as an orphan drug, is now meeting with authorities to have propranolol to be relicensed as an official cancer drug.
New application to detect skin cancer
Computer scientists at Stanford University wrote an algorithm to artificially diagnose skin cancer merely based on pictures of birthmarks. With a database of almost 130,000 skin disease images, they trained the system to visually diagnose potential cancer. The research team compared the application’s skills to the judgement of dermatologists, showing the algorithm perfectly matched the doctors’ capability to diagnose the most common and deadliest skin cancers. Currently, the algorithm is available on computers only, but is under development to make it smartphone compatible. Prospective validation of the application is needed before it can be implemented in clinical practice. Skin cancer has a prevalence of 3-25 per 100,000 people and early detection could have a tremendous impact on skin cancer outcomes: the 5-year survival in the earliest stages is around 97% but drops to approximately 14% when detected later on. The study was published in Nature.
TerSera acquires AstraZeneca’s rights of Zoladex
AstraZeneca and TerSera entered into an agreement for the commercial rights of Zoladex, an injectable luteinizing hormone-releasing hormone agonist for the treatment of prostate cancer and breast cancer, as well as for several other benign gynaecological disorders. AstraZeneca will receive $250 million upon completion, as well as sales-related income through milestones up to $70 million, plus additional recurring sales-based payments of a percentage Product Sales. With this deal, AstraZeneca aims to concentrate on new innovative oncology medicines, while maintaining Zoladex accessible for patients
EMA / FDA
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for:
- Pemetrexed (Pemetrexed, Hospira) for the treatment of unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology. The anti-folate agent disrupts folate-dependent metabolic processes essential for cell replication. Pemetrexed is a generic of Alimta, which has been authorized in the EU since September 2004.
- Rolapitant (Varuby, Tesaro) for the prevention of delayed nausea and vomiting as a result of chemotherapy in adults. Chemotherapy can cause the body to release substance P which binds to nerve cells in the brain’s area postrema (vomiting center) making a patient feel sick or be sick. Rolapitant blocks the binding of substance P to these nerve cells and this helps prevent nausea and vomiting.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive recommendation on extensions for:
- Daratumumab (Darzalex, Janssen-Cilag) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. The monoclonal antibody was earlier approved as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.
- Trametinib (Mekinist, Novartis) in combination with dabrafenib (Tafinlar, Novartis Europharm) for the treatment of adult patients with advanced non-small cell lung cancer with a BRAF V600 mutation. Trametinib, a MEK inhibitor, was earlier approved as monotherapy, and also in combination with the B-Raf inhibitor for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.
The FDA granted approval for:
- Lenalidomide (Revlimid, Celgene Corp) as maintenance therapy for patients with Multiple Myeloma (MM) following autologous stem cell transplant. Already back in 2006, the thalidomide analogue was approved by the FDA in combination with dexamethasone for the treatment of patient with multiple myeloma who at least received one prior therapy, and extended in 2015 for patients who are not eligible for autologous stem cell transplant. Lenalidomide is also approved for the treatment of myelodysplastic syndromes and mantle cell lymphoma.
The FDA granted accelerated approval for:
- Nivolumab (OPDIVO, Bristol-Myers Squibb) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who progressed during or following platinum-containing chemotherapy, or progressed within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The PD-1 inhibitor was already approved for metastatic melanoma, squamous NSCLC and renal cell carcinoma.