Emerging Therapies

San Diego, CA—In a first-in-human study of a novel bispecific T-cell engager (BiTE), AMG 420, when administered at a daily dose of 400 mcg, this novel drug induced responses in 7 of 10 patients with heavily pretreated multiple myeloma in a phase 1 clinical trial, according to results presented at ASH 2018.
San Diego, CA—Selinexor has shown promising activity in very heavily pretreated patients with penta-refractory multiple myeloma. In the pivotal STORM Part 2 study, oral selinexor in combination with low-dose dexamethasone induced responses in 26.2% of patients.
San Diego, CA—A chimeric antigen receptor (CAR) T-cell therapy that targets CD19 and CD22 molecules has demonstrated safety and efficacy, in patients with relapsed or refractory B-cell precursor acute lymphoblastic lymphoma (ALL), with response rates consistent with CAR T-cell therapies that target CD19 alone.
Ivosidenib is a potent oral inhibitor of the IDH1 mutation. In a new study presented at ASCO 2018, ivosidenib achieved durable remissions and molecular remissions in some patients with advanced relapsed or refractory acute myeloid leukemia (AML) and IDH1 mutation. In this phase 1 clinical trial, approximately 33% of the patients who received this drug became transfusion-independent. At a dose of 500 mg daily, ivosidenib has been associated with a low frequency of grade ≥3 treatment-related adverse events.
The investigational LOXO-292, a potent and highly selective RET kinase inhibitor, has demonstrated robust and durable antitumor activity against RET-activating fusions and mutations.
Chicago, IL—Larotrectinib (LOXO-101), an investigational agent that targets tropomyosin receptor kinase (TRK) fusions, has demonstrated excellent, consistent, and durable antitumor activity in a range of tumor types in adults and children, reported lead investigator David M. Hyman, MD, Chief, Early Drug Development Service, Memorial Sloan Kettering Cancer Center, New York City, at the 2017 ASCO annual meeting. Larotrectinib was called “the first oral tumor-agnostic therapy,” because of its unprecedented high response rates in 17 tumor types that express TRK.
Chicago, IL—The investigational, second-generation EGFR inhibitor dacomitinib reduced the risk for disease progression compared with gefitinib as first-line therapy for patients with advanced non–small-cell lung cancer (NSCLC) and EGFR mutation. Results from the phase 3 ARCHER 1050 clinical trial demonstrated a >40% reduction in the risk for disease progression and an average 6.5-month improvement in the duration of response with dacomitinib versus gefitinib.
Chicago, IL—Oral cediranib, an investigational vascular endothelial growth factor (VEGF) inhibitor, in combination with a poly ADP-ribose polymerase (PARP) inhibitor or with chemotherapy, shows survival benefit in women with relapsed platinum-sensitive ovarian cancer, according to data from 2 studies presented at the 2017 ASCO annual meeting.
Chicago, IL—A new high-intensity genomic sequencing strategy (developed by Grail Inc) detects circulating tumor DNA (ctDNA) at a high rate. The new approach is a major improvement on previous tests using ctDNA, which focus on a limited number of driver mutations to inform treatment strategies for metastatic disease or to monitor disease burden. The new test offers ultra-deep sequencing with a broad genomic coverage, but it is not ready for prime time to detect occult cancer. At present, the test is a research platform and is not commercially available.
San Diego, CA—The investigational chimeric antigen receptor (CAR) T-cell therapy KTE-C19 achieved complete responses that were durable for >1 year in more than 75% of patients with aggressive lymphomas who had no other effective treatment options, according to results from the phase 2 pivotal clinical trial ZUMA-1 that were presented by Sattva S. Neelapu, MD, Department of Lymphoma/Myeloma, M.D. Anderson Cancer Center, at the 2016 American Society of Hematology meeting.
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