TON Web Exclusives

New results from the phase 3 QuANTUM-R trial showed that quizartinib, an oral, selective FLT3 inhibitor, significantly extended overall survival compared with chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) and the FLT3-ITD mutation.

This week Sellas Life Sciences Group announced data from a study of NeuVax (nelipepimut-S) in combination with Herceptin (trastuzumab) in patients with HER2 1+/2+ breast cancer.
A post hoc analysis of the phase 2 ALTA trial showed longer overall survival in crizotinib-refractory patients with advanced ALK-positive NSCLC who continued brigatinib versus discontinuing it after disease progression.
In treatment-naïve patients with NSCLC and high tumor mutation burden—regardless of PD-L1 expression—the combination of nivolumab plus ipilimumab showed superior PFS versus chemotherapy in the phase 3 CheckMate-227 trial.
Amid the changing landscape of treatments for ALK-positive NSCLC, sequencing of ALK inhibitors grows more complex and will require an assessment of individual patient’s tumor characteristics.
Seribantumab (MM-121), a drug under investigation in the phase 2 SHERLOC trial for the treatment of heregulin-positive NSCLC, was granted orphan drug designation from the FDA.
The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology have updated their 2013 molecular analysis guideline for the selection of patients with lung cancer for TKI treatment, to include 18 new recommendations and 3 revisions to the existing guidance.
In patients with HR-positive breast cancer, a positive circulating tumor cells assay result was associated with nearly a 20-fold increased risk for recurrence of disease.
Older women with hormone receptor–positive, HER2-negative metastatic breast cancer who are treated with a CDK4/6 inhibitor may derive benefits similar to those seen in their younger counterparts.
Based on results from the phase 3 FLAURA trial, the FDA has granted osimertinib (Tagrisso) breakthrough therapy designation for treatment-naïve patients with EGFR-positive non–small-cell lung cancer.
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