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The assay will identify patients with mutations in HER2 who may be eligible for treatment with a HER2-directed antibody-drug-conjugate developed by Daiichi.
Some oncologists said 10 mutations/Mb is an acceptable TMB cutoff in patients who are out of options, while others worry it will drive immunotherapy use in those unlikely to have a lasting benefit.
The company will study its investigational drug rigosertib in combination with Opdivo in patients with KRAS-mutated lung cancer.
Investigators saw responses in one colorectal cancer and one breast cancer patient and are now studying differences between responders and non-responders.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.
The findings underscore the utility of universal germline testing in young adults diagnosed with cancers that are more common in older populations.
The drug, which is designed to restore normal functioning of p53, has allowed a promising proportion of TP53-mutated MDS patients to receive stem cell transplants in early trials.
Christiana Care researchers have identified a unique protospacer adjacent motif site that allows them to knock out the NRF2 gene in tumor cells while leaving normal cells alone.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The work suggests mass spec can more accurately assess levels of immunotherapy targets like PD-L1 than conventional clinical approaches.
GNS Healthcare will apply its AI and simulation technology to data from the CoMMpass study in search of insights on disease progression and drug response.
The firm's technology uses ex vivo organ culture to model cancer growth and predict a patient's tumor response to chemotherapy and targeted drugs.
ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.
A study found that patients with a mutation in ARID1A and expression of immune cytokine CXCL13 had better overall survival on immune checkpoint inhibitors.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The agency approved the drug based on a study that showed that Mylotarg combined with chemo extended event-free survival compared to chemo alone.
The company raised $74.5 million in a series B financing round last December, with which it hopes to study its RAF inhibitor in various cancers with non-V600 BRAF mutations.
The suggestions make up a conceptional framework that, if implemented, may help bring precision oncology to more cancer patients in Germany, experts wrote in a paper.
The collaboration will allow oncologists a streamlined view of the treatments and trials available to patients based on their genomic profile.
The company will initiate a Phase I/II clinical trial in patients with HER2-positive solid tumors later this year.