Immuno-Oncology | Specialty

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.

Ramucirumab/Pembrolizumab Produces Encouraging ORR in Recurrent or Metastatic HNSCC

January 17th 2022

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.

New, Updated Data Demonstrate Promising Future in Advanced Melanoma

January 14th 2022

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.

Immunotherapy Outcomes in HPV-Associated Head and Neck Cancer Fuel Investigative Efforts

January 14th 2022

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.

GLORIA Trial Examining NOX-A12 Plus Radiotherapy/Bevacizumab in Glioblastoma Safe to Continue Recruitment

January 11th 2022

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 Pembrolizumab Improves DFS in Stage IB-IIIA NSCLC, Irrespective of PD-L1 Expression

January 10th 2022

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.

Pembrolizumab/Pepinemab Combo Safe, Well Tolerated in Advanced, Recurrent, or Metastatic HNSCC

January 7th 2022

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.

Novel Immunotherapy Combos Target TIM-3 and PD-1/PD-L1 Networks

January 7th 2022

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.

FDA Accepts IND for RM-1995 Photoimmunotherapy in Advanced Cutaneous or Head and Neck SCC

January 6th 2022

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.