For patients with activating mutations to the EGFR receptor kinase, small molecule specific inhibitors Iressa (gefintinib) or Tarceva (erlotinib) are administered as front-line treatments. But, non-small cell lung cancers develop resistance after about one year of treatment via a single recurrent missense mutation (T790M) to the tyrosine kinase. This is similar to resistance observed in patients with CML (Chronic Myeloid Leukemia) following treatment Gleevec (imatinib), which is mediated by a mutation to the Bcr-Abl transgene. Continue reading
Category Archives: Therapy
PARP inhibitor rejected by FDA Advisory Committee, then Approved for refractory patients
In June 2014, the FDA Oncology Drug Advisory Committee voted 11-2 to delay approval of AstraZeneca’s olaparib, a PARP (poly-ADP ribose polymerase) inhibitor for maintenance therapy in patients with ovarian cancer. The product received Accelerate Approval designation from the FDA, which provides for conditional approval pending follow-up studies, based on surrogate endpoints from Phase 2 trials, in this case, progression-free survival (PFS). Continue reading
Nivolumab Phase 3 study stopped early for efficacy
Great news – nivolumab, BMS’ PD-1 immune checkpoint control inhibitor was shown to prolong overall survival when used front-line in patients with advanced melanoma. The study was stopped early, that is before it fully enrolled the planned number of patients, by an independent data monitoring committee because it was shown to be quite effective. Continue reading
Precision Medicine: SWOG Lung-MAP study – unique public/private collaboration
Using genomics to take-on advanced non-small cell lung cancer, the Southwest Oncology Group announced the start of a master protocol that will screen patients for optimal eligibility into one of five clinical trials with experimental drugs… Continue reading
Autophagy inhibitors for resistant cancers
Autophagy is a process by which cells that are under stress and deprived of nutrients pause to recycle themselves in order to maintain viability. Autophagosomes comprised of cellular organelles are formed, followed by Lysosomal destruction; the cell then uses the substrates for synthesis and reconstitution. Cells in autophagy do not replicate… Continue reading
OncoMed’s Wnt-targeted experimental cancer drugs and bone-related adverse events
OncoMed is a biotech company that is developing therapies directed at the Wnt and Notch signaling pathways. Clinical studies with two products directed at the Wnt pathway (Vantictumab – anti-Fzd-7, and Fzd-8 Fc) have been halted by the company while it explores findings of bone toxicity. Continue reading