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The new drug developer's current pipeline consists of CAR-NK cell drugs targeting HER2-positive tumors and CD19-positive B-cell malignancies, as well as a universal NK cell therapy.
The committee recommended the tumor-agnostic drug for use in the Cancer Drugs Fund while awaiting mature survival data from ongoing clinical trials.
In the study, pelareorep will be combined with paclitaxel and the PD-L1 inhibitor Bavencio in patients with HR-positive, HER2-negative breast cancer.
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.
The company will study its investigational drug rigosertib in combination with Opdivo in patients with KRAS-mutated lung cancer.
By combining with ArcherDX, Invitae will gain tumor profiling and liquid biopsy technologies for predicting and monitoring therapeutic response.
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.
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.
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.