IMMUNOTHERAPY

Nivolumab (Opdivo) was given an accelerated approval by the FDA for the treatment of patients with hepatocellular carcinoma following prior treatment with sorafenib (Nexavar). The approval was granted for patients regardless of their PD-L1 status. 

Median overall survival findings from treatment with pembrolizumab (Keytruda) were significantly longer compared with chemotherapy in patients with recurrent, advanced urothelial carcinoma, according to mature results from the phase III KEYNOTE-045 study. 

Prospects for patients with non-small cell lung cancer have improved with the identification of actionable mutations and the development of targeted agents; however, patients without actionable mutations do not experience improved outcomes with these targeted therapies.

Supplemental Biologics License Applications (sBLAs) were sent to and accepted by the FDA for a new dosing schedule for nivolumab (Opdivo) across all of the agent's indications as a montherapy, according to Bristol-Myers Squibb (BMS), the manufacturer of the PD-1 inhibitor. 

Checkpoint inhibitors against PD-1 and PD-L1 have demonstrated promising efficacy as monotherapies and in combination with chemotherapy for patients with triple-negative breast cancer, with phase III data on the horizon

As a first step toward developing quantitative models, investigators recently developed a mathematical framework to simulate the systemic dissemination of T cells activated in response to focal therapy.

Adding the PD-1 inhibitor pembrolizumab (Keytruda) to standard neoadjuvant chemotherapy tripled the pathologic complete response (pCR) rate in multiple subtypes of HER2-negative breast cancer, according to results from the ongoing phase II I-SPY-2 clinical research program presented during the 2017 ASCO Annual Meeting.

More than 40% of patients with melanoma brain metastases achieved objective intracranial responses to combination treatment with nivolumab (Opdivo) and ipilimumab (Yervoy), results of a randomized phase II trial showed.

Treatment with chimeric antigen receptor (CAR) T cells that target B-cell maturation protein (BMCA) achieved clinical remissions in 33 out of 35 patients (94%) with relapsed or refractory multiple myeloma in early results from a Chinese study presented at the 2017 ASCO Annual Meeting.

When epacadostat, an IDO1 inhibitor, was combined with pembrolizumab (Keytruda), a PD-1 inhibitor, responses were seen in 35% of patients with advanced urothelial carcinoma, according to findings presented during the 2017 ASCO Annual Meeting.  

More than half of patients with immunotherapy-relapsed/refractory melanoma benefited from treatment with nivolumab and an anti-lymphocyte activation gene-3 (LAG-3) antibody, according to data from an early clinical study.

In updated findings from the KEYNOTE-059 trial of pembrolizumab in advanced gastric or gastroesophageal junction (GEJ) cancer, the PD-1 inhibitor maintained signs of its clinical benefit in this patient population, which is encouraging as the indication is currently under consideration for approval with the FDA.

Nivolumab (Opdivo) plus ipilimumab (Yervoy) or ipilimumab alone are associated with a high incidence of gastrointestinal (GI) toxicity, but most adverse events (AEs) are effectively managed using immunomodulators, which do not appear to inhibit tumor response. Additionally, nivolumab plus ipilimumab significantly improved overall survival (OS) and objective response rate (ORR) versus ipilimumab alone in patients with untreated advanced melanoma.

Combining the PD-1 inhibitor pembrolizumab (Keytruda) with the HDAC inhibitor entinostat demonstrated promising clinical activity and acceptable safety in patients with melanoma who were refractory to immune checkpoint inhibitors. 

Barbara McAneny, MD, the chief executive officer of New Mexico Cancer Center, discusses how oral targeted therapies and immunotherapies disrupted the traditional methods for financing community practices.

As immunotherapies become a greater part of the treatment paradigm of various cancers, researchers are spending more time developing ways to determine which patients will respond better to immunotherapy. Mutational load is one such biomarker that appears to have an impact on response to immunotherapy, particularly for checkpoint inhibitors.

As the oncology community adapts to using immunotherapy agents more frequently in cancer treatments, the fear over immune-related adverse events (irAEs) prevents many clinicians from fully trusting immunotherapies.

Thomas Gajewski, MD, PhD, has been awarded an Outstanding Investigator Award by the National Cancer Institute.

Some key highlights from SITC’s 31st Annual Meeting

Roy Herbst, MD, PhD, discusses the next steps with pembrolizumab in non-small cell lung cancer following its FDA approval, including combination regimens.  

Geoffrey Sklar, MD, Chief Medical Officer, Chesapeake Urology Associates, discusses the possibility for immunotherapy as a neoadjuvant treatment in bladder cancer.

Luciano Mutti, PhD, professor in cancer research, University of Salford, Manchester, discusses the current and future role of immunotherapy in mesothelioma. 

Findings from an efficacy update of patients participating in a study in the CheckMate series revealed that first-line nivolumab (Opdivo) demonstrated activity in advanced non–small cell lung cancer, and the addition of ipilimumab (Yervoy) resulted in enhanced activity, specifically in prolonged progression-free survival and higher objective response rates.

D. Anda Norbergs, an oncologist based in Palm Harbor, Florida, has been indicted for purchasing unapproved cancer medications from foreign sources and defrauding Medicare, United States Attorney A. Lee Bentley, III has announced.

Maura N. Dickler, MD, medical oncologist, Memorial Sloan Kettering Cancer Center, discusses an ongoing clinical trial of the CDK4/6 inhibitor abemaciclib combined with the PD-L1 inhibitor pembrolizumab (Keytruda) for patients with hormone receptor (HR)-positive, HER2-negative breast cancer. She also sheds light on abemaciclib's unique mechanism of action.

Roy. S. Herbst, MD, PhD, professor of Medicine (Medical Oncology), professor of Pharmacology, chief of Medical Oncology, Yale Cancer Center, discusses the phase III KEYNOTE-010 study, in which pembrolizumab provided superior overall survival over docetaxel in patients with previously treated, PD-L1-expressing advanced non-small cell lung cancer. He discussed these results during an interview at the IASLC 17th World Conference on Lung Cancer.

Early data from a phase I/II study suggest that the combination of brentuximab vedotin and nivolumab may be an active and well-tolerated outpatient regimen in patients with relapsed/refractory classical Hodgkin lymphoma after failure of standard frontline chemotherapy.

Treatment with the CD19-directed CAR T-cell therapy KTE-C19 showed a complete remission rate of 73% for patients with aggressive, chemorefractory primary mediastinal B-cell lymphoma and transformed follicular lymphoma, according to findings from the multicenter phase II ZUMA-1 study.

Pembrolizumab (Keytruda), pomalidomide (Pomalyst), and dexamethasone had an objective response rate of 65% and a very good partial response or better rate of 29% for patients with relapsed/refractory multiple myeloma, according to phase II findings presented at the 2016 ASH Annual Meeting.