Silas Inman

Regorafenib (Stivarga) as a second-line therapy for patients with unresectable hepatocellular carcinoma (HCC) who have progressed on sorafenib (Nexavar), showed an improved overall survival (OS) rate of 2.8 months over placebo. Findings from the phase III RESORCE study will be submitted to the FDA and European Medicines Agency (EMA) for potential approval, according to a statement from the developer of regorafenib, Bayer Pharmaceuticals.

Adding utomilumab (PF-05082566), a 4-1BB agonist, to pembrolizumab (Keytruda), a PD-1 inhibitor, was shown to be a safe and effective combination therapy for patients with different types of advanced solid tumors, according to findings from a phase Ib study presented at the 2016 ASCO Annual Meeting.

Avelumab showed early positive survival data and lasting responses for patients with pretreated advanced or metastatic Merkel cell carcinoma, according to findings from the phase II JAVELIN Merkel 200 trial presented at the 2016 ASCO Annual Meeting.

Pembrolizumab (Keytruda), when studied in 2 clinical trials for the treatment of patients with pretreated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), showed an objective response rate (ORR) of 18%, according to findings presented at the 2016 ASCO Annual Meeting.

Ibrutinib (Imbruvica) continued to demonstrate impressive antitumor activity in a pooled analysis of 243 patients with deletion 17p chronic lymphocytic leukemia.

Three-year follow-up data from the phase III COMBI-d study was presented at the 2016 ASCO Annual Meeting, revealing impressive overall survival (OS) and progression-free survival (PFS) data for the dabrafenib (Tafinlar) and trametinib (Mekinist) combination therapy for patients with BRAF-mutant metastatic melanoma.

Patients with recurrent glioblastoma mutliforme reacted well to nivolumab (Opdivo) monotherapy, according to findings from the CheckMate-143 trial that were presented at the 2016 ASCO Annual Meeting. The single agent showed a manageable safety profile and promising efficacy signs during the course of the study.

Nivolumab (Opdivo) monotherapy showed improved overall survival (OS) and objective response rates for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) compared with the investigator's choice of alternative therapy, according to data presented at the 2016 ASCO Annual Meeting.

Combination therapy dabrafenib and trametinib showed positive outcomes in patients with BRAF V600E-mutant NSCLC, according to phase II trial data presented at the 2016 ASCO Annual Meeting.

Treatment with the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine demonstrated single-agent activity and a manageable safety profile for patients with recurrent/refractory SCLC.

Clinical trials studying a biomarker-based treatment showed substantially better results than non-personalized treatment methods in a meta-analysis that examined 13,203 patients from phase I trials.

A phase III study exploring the combination of olaparib and paclitaxel missed its primary endpoint of improvement in overall survival compared with paclitaxel and placebo for patients with advanced gastric cancer.

The FDA has granted a genetically modified version of the poliovirus known as PVS-RIPO a breakthrough therapy designation as a potential therapy for patients with advanced glioblastoma multiforme.

Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.

The combination of lenvatinib (Lenvima) and everolimus (Afinitor) has been approved by the FDA as a treatment for patients with advanced renal cell carcinoma (RCC) following prior antiangiogeneic therapy.

The Committee for Medicinal Products for Human Use has recommended the first-line approval of bevacizumab (Avastin) in combination with erlotinib (Tarceva) for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer.

A number of novel therapies are currently being explored as second-line treatments for patients with advanced hepatocellular carcinoma, including a host of targeted therapies and various immune checkpoint inhibitors.

With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.

Nivolumab (Opdivo) has been granted a breakthrough therapy by the FDA as a treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following a platinum-based therapy.

The phase III PALOMA-2 trial has shown a significant improvement in progression-free survival (PFS) for the frontline combination of palbociclib (Ibrance) and letrozole compared letrozole alone for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.

The FDA has granted a breakthrough therapy designation to pembrolizumab (Keytruda) as a treatment for patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Novel combination approaches are currently under exploration that hope to capitalize on the varying mechanisms of action for each newly approved agent for men with metastatic castration-resistant prostate cancer (mCRPC).

Single-agent nivolumab (Opdivo) demonstrated a robust 5-year overall survival (OS) rate of 34% for heavily pretreated patients with metastatic melanoma who had not received prior ipilimumab (Yervoy), according to long-term findings from a single-arm phase I study.

Treatment with the novel multikinase inhibitor entrectinib achieved objective responses in 79% of patients with solid tumors associated with NTRK, ROS-1, or ALK rearrangements.

The FDA has granted a priority review designation to pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following a platinum-based chemotherapy, according to a statement from Merck, the company developing the PD-1 inhibitor.

Immunotherapy should be considered along with VEGF and mTOR TKIs as a highly effective treatment modality for patients with metastatic renal cell carcinoma (RCC).

Following a series of meetings with the FDA, Puma Biotechnology announced that it plans to delay the submission of a new drug application (NDA) until mid-2016 for neratinib.

An upcoming FDA decision for the PD-L1 inhibitor atezolizumab as a treatment for patients with bladder cancer could set the stage for an onslaught of new and highly effective immuno-oncology agents, according to Daniel Petrylak, MD.

Despite the letdown of prior research, the future looks bright for immunotherapies and novel targeted approaches for patients with gliomas, many of which have already been developed for other types of cancer.

Treatment with gefitinib (Iressa) failed to show noninferiority compared with erlotinib (Tarceva) for patients with pretreated non-small cell lung cancer (NSCLC).