Immuno-Oncology

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.

James P. Allison, PhD, a Nobel Laureate and Giants of Cancer Care® award winner, will head up the new James P. Allison Institute at The University of Texas MD Anderson Cancer Center.

Durvalumab given concurrently with chemoradiation was not found to significantly improve progression-free survival vs chemoradiation alone in patients with locally advanced cervical cancer, missing the primary end point of the phase 3 CALLA trial.

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Hussein A. Tawbi, MD, PhD, discusses the recent FDA approval of relatlimab/nivolumab in metastatic melanoma, the significance of the regulatory decision, and potential avenues for further exploration of the regimen.

Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.

The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.

Patient-reported outcome data support a favorable benefit/risk profile for the combination of pembrolizumab plus chemotherapy, with or without bevacizumab, in patients with persistent, recurrent, or metastatic cervical cancer.

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.

Jonathan D. Cheng, MD, discusses the various categories of immuno-oncology, including checkpoint inhibitors, immunotherapy combinations, and TKIs, that are moving the modality forward.

Fenghuang Zhan, MD, PhD, and John D. Shaughnessy, Jr, PhD, discuss the need for a paradigm shift in the treatment of multiple myeloma with the integration of immunotherapy.

The FDA has placed a partial clinical hold on the phase 1 NEON-2 trial examining the combination of davoceticept and pembrolizumab in patients with advanced solid tumors or lymphoma.

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.