Immuno-Oncology | Specialty

Frontline Bempegaldesleukin/Nivolumab Combo Misses Primary End Points in Unresectable or Metastatic Melanoma

March 14th 2022

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.

Cheng Explores the Evolution of Immunotherapy in the Cancer Field

March 12th 2022

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

Charting a Path for the Integration of Immunotherapy in the Treatment of Multiple Myeloma

March 11th 2022

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.

FDA Places Partial Clinical Hold on NEON-2 Trial Evaluating Davoceticept/Pembrolizumab in Advanced Cancers

March 8th 2022

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.

FDA Approves Neoadjuvant Nivolumab/Chemo for Resectable NSCLC

March 4th 2022

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

FDA Grants Priority Review to Neoadjuvant Nivolumab/Chemo for Resectable NSCLC

February 28th 2022

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.

Nivolumab/Ipilimumab Nears EU Approval for Frontline PD-L1+ Unresectable Advanced, Recurrent or Metastatic ESCC

February 25th 2022

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.

Adjuvant Nivolumab Approaches EU Approval for Select High-Risk Muscle-Invasive Urothelial Carcinoma

February 25th 2022

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.

Taming the Wild West: the View From the FDA

February 22nd 2022

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.

FDA Approves FoundationOne CDx as Companion Diagnostic for Pembrolizumab in MSI-H Solid Tumors

February 21st 2022

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.

FDA Grants Fast Track Status to IO-202 for Relapsed/Refractory AML

February 17th 2022

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.

Checkpoint Inhibitor Changes Take Hold: Approval Standards Stir Debate

February 16th 2022

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.

Biomarker Developments Continue to Shape Immunotherapy Treatment Paradigm for GI Cancers

February 11th 2022

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

Immunotherapy Advances Drive Progress in Lung Cancer Treatment

February 5th 2022

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.

Pelareorep/Atezolizumab Plus Chemo Shows Early Safety in Frontline Metastatic Pancreatic Cancer

February 3rd 2022

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.

Biden-Harris Administration Revives Cancer Moonshot Program

February 3rd 2022

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.

Cosibelimab Elicits Encouraging Responses in Metastatic Cutaneous Squamous Cell Carcinoma

January 25th 2022

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.

TST001 Under Evaluation in Locally Advanced or Metastatic Solid Tumors

January 23rd 2022

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.

Sugemalimab Plus Chemo Significantly Improves Survival in Frontline Stage IV NSCLC

January 19th 2022

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.

Durvalumab Plus Chemotherapy Improves Survival in Advanced Biliary Tract Cancer

January 18th 2022

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.