Immuno-Oncology | Specialty

PRO Data Support the Use of Pembrolizumab Combo in Persistent, Recurrent, or Metastatic Cervical Cancer

March 19th 2022

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.

FDA Grants Fast Track Status to 7HP349 for PD-1–Resistant Metastatic Melanoma

March 17th 2022

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.

Guardant360 CDx Approved in Japan for Utilization in Advanced Solid Tumors

March 16th 2022

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

Relatlimab/Nivolumab Combo Continues to Impress in Previously Untreated Metastatic or Unresectable Melanoma

March 15th 2022

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.

Phase 3 KEYLYNK-010 Trial Examining Pembrolizumab/Olaparib in mCRPC to Stop for Futility

March 15th 2022

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.

Frontline Cabozantinib/Atezolizumab Does Not Improve OS Over Sorafenib in Advanced HCC

March 15th 2022

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.

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.