Immuno-Oncology

The FDA has approved nivolumab plus platinum-doublet chemotherapy for adult patients with resectable non–small cell lung cancer in the neoadjuvant setting.

The FDA has granted priority review to a supplemental biologics license application for the combination of nivolumab and chemotherapy in the neoadjuvant treatment of patients with resectable non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for use as an adjuvant treatment in adult patients with muscle-invasive urothelial carcinoma with a PD-L1 expression of at least 1% on tumor cells, who are at a high risk of recurrence following radical resection.

Julia A. Beaver, MD discusses the need for greater collaboration among industry sponsors on diagnostics, regulatory submissions, and multinational clinical trials involving PD-1/PD-L1 immune checkpoint inhibitors.

The FDA has given the green light to the FoundationOne CDx for use as a companion diagnostic that can be leveraged to identify patients with microsatellite instability high solid tumors who may be candidates to receive and derive benefit from pembrolizumab.

The FDA has granted a fast track designation to IO-202, a first-in-class anti-LILRB4 myeloid checkpoint inhibitor, as a potential therapeutic option for patients with relapsed or refractory acute myeloid leukemia.

the development of PD-1/PD-L1 immune checkpoint inhibitor therapy underwent a course correction in 2021, with the withdrawal of a range of indications due to study results that failed to reach thresholds for confirming clinical benefit.

The utilization of monoclonal antibodies such as nivolumab and Ipilimumab have become vital in shifting the treatment paradigm in gastroesophageal and gastrointestinal cancers.

In the past 2 years, key data from clinical trials in advanced lung cancer have demonstrated that immunotherapy has expanded the bounds of the armamentarium for the treatment of several lung cancers.

The 3-patient safety run-in for the pancreatic cancer cohort of the ongoing phase 1/2 GOBLET study did not reveal any safety concerns with the novel combination of pelareorep and atezolizumab.

The Biden-Harris administration has announced a plan to restart the Cancer Moonshot initiative, which President Joe Biden first launched as vice president of the Obama administration in 2016.

The PD-L1 antibody cosibelimab, when given at a fixed dose of 800 mg every 2 weeks, elicited a promising objective response rate with acceptable safety and tolerability in patients with metastatic cutaneous squamous cell carcinoma, meeting the primary end point of a phase 1 registration-enabling trial.

The safety and tolerability of TST001 is under investigation as a potential treatment option for patients with gastric/gastroesophageal junction cancer and other locally advanced or metastatic solid tumors as part of a phase 1 trial.

The addition of the PD-L1 inhibitor sugemalimab to chemotherapy significantly improved overall survival compared with chemotherapy alone in the frontline treatment of patients with stage IV non–small cell lung cancer.

Treatment with the PD-L1 inhibitor durvalumab in combination with gemcitabine and cisplatin resulted in significantly improved overall survival vs placebo plus chemotherapy in patients with advanced biliary tract cancer.

The addition of ramucirumab to pembrolizumab elicited an encouraging response rate when used in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Jeffrey S. Weber, MD, PhD, overviews the successes made in the melanoma setting in the past decade and the challenges to overcome in the future.

Robert L. Ferris, MD, PhD, discusses the current standard of care for patients with head and neck cancer, the role of HPV in treatment decisions, and the need to personalize therapy for patients.

The Data Safety Monitoring Board has determined that it is safe and appropriate to continue recruitment to the expansion arm of the phase 1/2 GLORIA trial, which is examining a novel combination comprised of NOX-A12, radiotherapy, and bevacizumab in glioblastoma and incomplete tumor resection.

Adjuvant treatment with pembrolizumab led to a statistically significant and clinically meaningful improvement in disease-free survival vs placebo in patients with stage IB to IIIA non–small cell lung cancer following resection, regardless of PD-L1 expression, meeting 1 of the dual primary end points of the phase 3 KEYNOTE-091 trial.

The combination of pembrolizumab and pepinemab showcased encouraging safety and tolerability when given as first-line treatment in patients with advanced, recurrent, or metastatic head and neck squamous cell carcinoma.

The immune checkpoint TIM-3 is shaping up to be a viable target for designing therapies for patients with non–small cell lung cancer and other malignancies.

The FDA has accepted an investigational new drug application for the photoimmunotherapy treatment, RM-1995, for patients with advanced cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

The addition of tiragolumab to atezolizumab produced a clinically meaningful improvement in progression-free survival, overall survival, and objective response rate compared with atezolizumab alone in the first-line treatment of patients with PD-L1–positive non–small cell lung cancer.