IMMUNOTHERAPY

No established regimens exist for the treatment of patients with advanced hepatocellular carcinoma after failure of first-line treatment with the multikinase inhibitor sorafenib. Outcomes in the setting of sorafenib resistance or intolerance are poor, with a median expected overall survival for the placebo arms of second-line trials in the range of 7 to 8 months.

In recent years, knowledge of hepatocellular carcinoma (HCC)-specific tumor-associated antigens and the development of immune checkpoint blockade therapy has offered a positive outlook for patients with HCC.

Three months ahead of schedule, nivolumab (Opdivo) has obtained FDA approval for patients with nonsquamous non-small cell lung cancer who progressed on or following platinum-based chemotherapy.

Gary D. Steinberg, MD, Bruce and Beth White Family Professor, professor of Surgery, director, Urologic Oncology, University of Chicago Medicine, discusses the potential of immunotherapy on the treatment of renal cell carcinoma.

Telesta Therapeutics has been granted an FDA advisory hearing to discuss the biologics license application of its MCNA immunotherapy as treatment for high-risk nonmuscle invasive bladder cancer following first-line bacillus Calmette-Guerin (BCG).

The immunotherapy, pembrolizumab (Keytruda), has been FDA approved for treatment in patients with pretreated advanced non-small cell lung cancer across all histologies with tumors expressing PD-L1.

Data from the pivotal KEYNOTE-001 trial showing pembrolizumab's efficacy in pretreated non-small cell lung cancer were presented just days before the FDA is scheduled to make its approval decision on the PD-1 inhibitor in this setting (October 2, 2015).

The combination of nivolumab and ipilimumab has received accelerated FDA approval as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Treatment with nivolumab demonstrated clinical efficacy and safety in patients with platinum-resistant, recurrent, or advanced ovarian cancer.

Talimogene laherparepvec (T-VEC), an attenuated oncolytic virus, combined with pembrolizumab, an immune checkpoint inhibitor, passed an early safety evaluation for unresectable melanoma.

Two strategies of successive immunotherapy for the treatment of advanced melanoma recently showed similar safety and tolerability, yet substantially different efficacy.

Provectus Biopharmaceuticals, Inc recently announced it has completed development of its protocol for phase Ib/II testing in patients with stage IV melanoma.

Over a fifth of patients with previously treated advanced nasopharyngeal carcinoma showed a measureable response, when treated with pembrolizumab, an immune checkpoint inhibitor.

Clinical evaluation suggests a role for immune checkpoint inhibition in the treatment of patients with lymphomas, but early success has also raised many questions.

A sarcoma study arm of the phase II portion of the multiarm PembroPlus clinical trial that combines immunotherapy with chemotherapy has commenced at Cancer Treatment Centers of America (CTCA), Western Regional Medical Center, Goodyear, Arizona

The Inaugural International Cancer Immunotherapy Conference commenced September 16, 2015, in New York City, and one presentation detailed Biothera's new biomarker strategy in patient selection for the company's investigational cancer immunotherapy, Imprime PGG.

Frequency of the cell death-regulating protein Bim (BCL-2-interacting mediator of cell death) may predict patient response to PD-1 inhibitor immunotherapy.

Srdan Verstovsek, MD, PhD, the University of Texas MD Anderson Cancer Center, discusses immunotherapy in myelofibrosis.

Activation of T-cell function has become a main focus of immunotherapeutic approaches aimed at enhancing an anticancer immune response and suppressing mechanisms used by tumor cells for immune evasion.

Nivolumab (Opdivo) and ipilimumab (Yervoy), a chemotherapy-free regimen, showed activity as a first-line therapy for patients who have advanced non-small cell lung cancer (NSCLC).

A novel immunotherapy, EGEN-001, combined with pegylated liposomal doxorubicin (PLD) has demonstrated clinical benefit in recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal cancer patients.

Nivolumab (Opdivo) was given a priority review designation by the FDA for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC).

Judd W. Moul, MD, urologic oncologist, Duke Medicine, discusses the impact of immunotherapy in prostate cancer.

A priority review designation was recently assigned by the FDA to the intravesical immunotherapy MCNA as a treatment for patients who have high-risk non-muscle invasive bladder cancer, following first-line bacillus Calmette-Guérin (BCG) therapy.

Bishoy M. Faltas, MD, Fellow, Hematology/Oncology, Weill Cornell Medical College, discusses immunotherapy in platinum-resistant bladder cancer.