CD-19 expression stays as eligibility criteria for cell therapy
MSAC has rejected a proposal to amend the eligibility criteria for tisagenlecleucel (TIS) (Kymriah) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
Novartis had applied for removal of the requirement for patients to test positive for CD-19 expression on their B-cells in order to access the CAR T cell therapy.
This followed evidence from the JULIET study that there was no clear relationship between low and high CD-19 expression and response to TIS.
However MSAC disagreed.
“MSAC considered that since tisagenlecleucel is a cell-based therapy specifically targeting CD-19 expression, and since there is no minimum threshold set for CD-19 positivity, the argument for removing the requirement was not adequately supported,” the Public Summary Document said.
MSAC also noted that removing the criteria for CD-19 positivity would have potential implications for axicabtagene and childhood acute lymphoblastic leukaemia.
Will haematology patients respond to COVID19 vaccine?
A new study will investigate whether patients with conditions such as cancers that compromise the immune system will be well-protected by current COVID-19 vaccines.
The OCTAVE trial will enrol up to 5,000 people in the UK, and will compare immune responses to COVID-19 vaccination in those with cancer, inflammatory arthritis, liver or kidney diseases, or who have undergone a stem cell transplant with a control group of individuals without these conditions.
The results will be based on blood test-based measures of immune response taken before and after vaccination.
“Patients with significant underlying diseases were generally excluded from COVID-19 vaccine studies to date – it is now important to confirm that the COVID-19 vaccines work well in such conditions,” said Prof Pam Kearns, of the University of Birmingham’s Cancer Research UK Clinical Trials Unit.
“Current evidence shows that people with these medical conditions may not obtain optimal protection from established vaccines,” Prof Kearns said.
Palliative care workforce crisis
Australia is facing a crisis in end-of-life care with only half the number of palliative care doctors needed to provide good quality care for terminally ill patients and increasing demand from an ageing population, a new report says.
Healthcare benchmarks require a two full-time equivalent palliative care physicians per 100,000 people in the population but Australia currently has only 0.9, according to a publication released by The PM Glynn Institute study at the Australian Catholic University. It says terminally ill patients are unable to access palliative care in the community and the situation will worse unless Australia trains an additional 225 specialist palliative care doctors.