KRAS inhibitor approved for NSCLC
The KRAS inhibitor sotorasib (Lumakras) has received TGA approval for treatment of adult patients with KRASG12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy for advanced disease.
According to the TGA decision statement, the decision to approve this indication was made on the basis of the objective response rate (ORR) and the duration of response (DOR) seen in clinical trials
The TGA said the rapid approval of sotorasib, following submission of the first application by Amgen Australia in March 2021 was expedited via Project Orbis in which the FDA Oncology Center of Excellence, Health Canada and the TGA collaboratively reviewed the application.
“Continued approval of this indication depends on the verification and description of benefit in confirmatory trials,” the TGA added.
Breast cancer election manifesto
With the federal election campaign now underway, breast cancer advocates have released a manifesto with recommendations including subsidisation of genetic and genomic profile testing on the Medicare Benefits Scheme and improvement to PBS processes to increase access to the least oncology therapies.
Other recommendations compiled by Breast Cancer Network Australia (BCNA) include reform of BreastScreen programs to reflect recent evidence towards risk-stratified breast screening, breast density, and new screening technologies.
BCAN calls for increased Medicare subsidies to support delivery of cancer follow-up care via telehealth, more breast care nurses, a national plan to clear elective surgery backlogs and more mental health support for people with breast cancer by growing the psycho-oncology workforce.
Melanoma genomic study identifies two loci linked to survival
Two genetic loci associated with melanoma survival have been identified by researchers at the QIMR Berghofer Medical Research Institute, Brisbane.
Using data from 5762 patients treated at the Melanoma Institute Australia and more than 5200 melanoma patients from the UK Biobank study, researchers conducted genome-wide association studies that found two independent, novel, genome-wide significant loci for melanoma-specific survival.
The findings in medrxiv also showed that that increased genetic susceptibility for cutaneous melanoma, as measured by increase in a polygenic risk score susceptibility, was significantly associated with improved melanoma survival.
The study investigators said their findings would need to be confirmed in larger studies, but highlighted the potential clinical utility of polygenic risk score susceptibility for profiling and monitoring patients for melanoma outcomes following diagnosis during the “melanoma follow-up care program.”
“In combination with other prognostic factors, it could be used to guide patient care e.g. counselling on modification of mortality related non-genetic behaviours and lifestyle factors, or guide the direction of patient-specific treatment to help improve survival after diagnosis,” they wrote.
“It may also be useful for the stratification of patients while recruiting into clinical trials evaluating melanoma treatment and outcomes,” they added.