Silas Inman

Immune checkpoint inhibitor development is progressing as treatments for patients with acute myeloid leukemia and myelodysplastic syndrome, with a number of studies currently assessing new combination strategies.

The key to inducing durable responses with immunotherapy in multiple myeloma may depend on the effective use of combination strategies, particularly for the use of monoclonal antibodies.

The European Medicines Agency (EMA) has accepted and validated a marketing authorization application for avelumab as a treatment for patients with metastatic Merkel cell carcinoma.

A recent phase III trial showed custirsen combined with docetaxel failed to significantly extend overall survival (OS) compared with docetaxel alone as a second-line treatment for patients with NSCLC.

Denosumab (Xgeva) was shown to be noninferior to zoledronic acid (Zometa) at delaying skeletal-related events (SREs) for patients with multiple myeloma.

Nivolumab (Opdivo) has received a priority review designation from the FDA as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma.

Treatment with KTE-C19 demonstrated an objective response rate (ORR) of 79% and a complete remission (CR) rate of 52% for patients with aggressive, chemorefractory non-Hodgkin's lymphoma (NHL).

Adjuvant sunitinib (Sutent) prolonged disease-free survival (DFS) by 1.2 years compared with placebo following nephrectomy for patients with high-risk clear cell renal cell carcinoma (RCC).

The FDA has granted a priority review designation to daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy. 

Single-agent pembrolizumab (Keytruda) reduced the risk of death by 40% and improved progression-free survival (PFS) by 4.3 months compared with doublet chemotherapy for untreated patients with advanced non–small cell lung cancer (NSCLC) with PD-L1 expression on ≥50% of cells, according to findings from the phase III KEYNOTE-024 trial.

Maintenance therapy with the PARP1/2 inhibitor niraparib reduced the risk of progression or death by 73% compared with placebo for patients with germline <em>BRCA</em>-positive platinum-sensitive, recurrent ovarian cancer, according to findings from the phase III NOVA trial.

Jennifer Brown, MD, PhD, discusses the status of targeted therapy agents for the treatment of patients with CLL.

Part 1 of the phase III COLUMBUS trial has shown positive results for the combination of the BRAF inhibitor encorafenib (LGX818) and the MEK inhibitor binimetinib (MEK162) for patients with <em>BRAF</em>-mutant melanoma.

According to findings of a recent study,&nbsp;Induction therapy with the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) effectively induced complete remissions (CRs) for nearly three-fourths of patients with relapsed or refractory Hodgkin lymphoma prior to autologous stem-cell transplantation (ASCT)

A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA

Based on findings from the phase III TOURMALINE-MM1 study, the Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval for ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.

Niraparib has been granted a fast track designation by the FDA as a treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, the company developing the PARP inhibitor, Tesaro, has announced.

The FDA has approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on an improvement in progression-free survival (PFS) in the phase III COMPLEMENT-2 study.

A new drug application (NDA) has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non&ndash;small cell lung cancer (NSCLC) following resistance or intolerance to crizotinib (Xalkori).

Pfizer has announced plans to acquire the biopharmaceutical company Medivation, which is the developer of the androgen receptor inhibitor enzalutamide (Xtandi). Under the terms of the agreement, Pfizer will pay $81.50 per share in cash for Medivation, totaling approximately $14 billion. Both companies agreed to the transaction, which is expected to complete later this year.

The FDA has approved the PD-1 inhibitor pembrolizumab as a second-line therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma for those who have progression on a platinum chemotherapy.&nbsp;

The CDK4/6 inhibitor ribociclib (LEE011) has received a breakthrough therapy designation from the FDA for its potential as a frontline therapy when given in combination with letrozole for patients with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer.<br /> &nbsp;

The Committee for Medicinal Products for Human Use has recommended the approval of pegylated liposomal irinotecan in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.

The FDA has approved a lighter and more convenient version of the Optune system for patients with glioblastoma multiforme.

The FDA has lifted a clinical hold placed on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.

Treatment with ARQ-087 demonstrated promising signs of clinical activity with a manageable safety profile for patients with FGFR2 fusion-positive advanced and/or metastatic intrahepatic cholangiocarcinoma, according to findings from an ongoing phase I/II study presented at the 2016 World Congress on Gastrointestinal Cancer.

Napabucasin, a STAT3-targeted agent, has received an orphan drug status from the FDA for the treatment of patients with gastric or gastroesophageal junction (GEJ) cancer.

Binimetinib, a MEK inhibitor, is seeking FDA approval in the treatment of patients with advanced NRAS-mutant metastatic melanoma.

For patients with early-stage invasive breast cancer and known estrogen receptor, progesterone receptor, and HER2 status, ASCO&#39;s February 2016 release of their evidence-based recommendations helped define appropriate use of biomarker assay results in guiding adjuvant treatment decisions.

Plasma-based genetic testing can effectively be used to determine whether a tissue biopsy is necessary for EGFR mutation analysis in patients with non-small cell lung cancer.