TGA approves improved treatment option for mesothelioma
Nivolumab (Opdivo) plus ipilimumab (Yervoy) has been TGA approved for first-line treatment of unresectable malignant pleural mesothelioma.
The combination’s registration is based on recent results from the CheckMate -743 trial, which found nivolumab plus ipilimumab improved overall survival compared to standard of care chemotherapy.
The international study, published earlier this year, found 2-year overall survival rates of 41% in the nivolumab plus ipilimumab group compared to 27% in the chemotherapy group.
The safety profile for nivolumab plus ipilimumab in first-line mesothelioma was manageable and consistent with previous studies of the combination in other tumour types.
The approval was granted under the TGA Priority Review process for treatments in areas of high unmet clinical need where substantial benefit has been demonstrated.
Diet in infancy affects asthma, allergies later in life
Excluding cow’s milk or introduction of soya milk in the first four months of life can increase the risk of atopy, wheeze, and asthma in adulthood, according to results from the Merthyr Allergy Prevention Study.
The trial included 487 infants at high risk of allergic disease; mothers in the intervention group were asked to restrict their cow’s milk intake for the remainder of their pregnancy and while breast feeding, as well as refraining from giving the infant any cow’s milk for at least the first 16 weeks of life.
At the age of 23 years, 299 of the subjects in the study completed a questionnaire, and 119 attended clinical assessments. Those in the intervention group had an increased risk of atopy, with an adjusted odds ratio of 2.97 (p = .01). The same was true of asthma, with an OR of 2.07 (p = .03). There was an increased risk of wheeze, but this was not statistically significant.
Earlier exposure to cow’s milk was associated with a decreased risk of wheeze and asthma at age 23. Earlier exposure to soya milk, on the other hand, was associated with an increased risk of atopy and asthma. “Diet in infancy affects allergic disease in adulthood,” the researchers concluded.
Lumacaftor-ivacaftor safe, effective over long term in young children with CF
Long-term results of a phase 3 study support the use of lumacaftor-ivacaftor for up to 120 weeks in young children with cystic fibrosis homozygous for the F508del-CFTR mutation.
The study, conducted across 20 centres in the US and Canada, previously found the regimen was generally well tolerated over 24 weeks of treatment in children aged 2-5. A total of 47 participants completed 96 weeks of treatment.
Of those, most patients had at least one adverse event during the study (98%), but most of these were mild (33% of participants) or moderate (51%). The most common adverse events included cough, nasal congestion, pyrexia, and others.
About one quarter of the cohort (26%) had at least one serious AE, most of which were consisting with underlying CF or common childhood illnesses. Respiratory AEs occurred in 9%, and none were serious or led to treatment discontinuation.
The improvements previously observed with the lumacaftor-ivacaftor regimen were generally maintained through week 96, including improvement to sweat chloride concentration, an increase in growth parameters and pancreatic function, and stable lung function relative to baseline.