Immuno-Oncology | Specialty

FDA Grants Fast Track Status to Eftilagimod Alpha for Frontline Recurrent/Metastatic Head and Neck Cancer

April 8th 2021

The FDA has granted a fast track designation to the soluble LAG-3 protein eftilagimod alpha for use in the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

Adjuvant Pembrolizumab Demonstrates Superior DFS Over Placebo in Post-Nephrectomy RCC

April 8th 2021

Single-agent pembrolizumab resulted in a significant improvement in disease-free survival when used as an adjuvant treatment in patients with renal cell carcinoma following nephrectomy or nephrectomy and resection of metastatic lesions, meeting the primary end point of the phase 3 KEYNOTE-564 trial.

Nivolumab-Based Combos Show Superior Survival Benefit Over Chemo in Unresectable Advanced or Metastatic ESCC

April 8th 2021

The combination of nivolumab and ipilimumab and nivolumab plus chemotherapy resulted in a statistically significant overall survival benefit compared with chemotherapy alone in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma.

FDA Recommends Termination of Phase 2 Trial Examining Immunotherapy ERC1671 in Glioblastoma

April 7th 2021

The FDA has recommended the early termination of a phase 2 trial examining the cell-based immunotherapy ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, cyclophosphamide, and bevacizumab in patients with glioblastoma.

Bhave Spotlights Breakthroughs Made With Immunotherapy Combinations in TNBC

April 6th 2021

Chemoimmunotherapy has become the standard of care for the frontline treatment of patients with PD-L1–positive, locally advanced or metastatic triple-negative breast cancer. However, understanding which patients will derive the most benefit from the approach is in need of further exploration

Updated Data Confirm Clinical Benefit of Novel Immunotherapy Combos in HCC

April 6th 2021

Daniel Lin, MD, MS, highlights pivotal trials evaluating immunotherapy regimens in patients with hepatocellular carcinoma, remaining sequencing questions, and emerging regimens that are showing promise.

Immunotherapy Agents Demonstrate Groundbreaking Data in GI Cancers

April 5th 2021

Lakshmi Rajdev, MD, discusses some of the key developments made with immunotherapy in GI cancers and the groundbreaking data that have recently read out to support their use.

Cabozantinib/Nivolumab Combo Approved in Europe for Advanced RCC

March 31st 2021

The European Commission has approved the combination of cabozantinib plus nivolumab for use as a frontline treatment in patients with advanced renal cell carcinoma.

Canadian Collaborative Launches to Provide Infrastructure for Cancer Cell Therapy Research

March 31st 2021

The Canada Foundation for Innovation has awarded C$5,187,685 to the Canadian Cancer Trials Group at Queen’s University in Kingston, Ontario, Canada, to fund the infrastructure for a new research platform to coordinate the development of new cancer cell therapies.

EU Panel Recommends Updated Label for Pembrolizumab in Select Locally Advanced or Metastatic Urothelial Cancer

March 30th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion in favor of recommending that the label for pembrolizumab in Europe be updated to include findings from the phase 3 KEYNOTE-361 trial.

FDA Issues Complete Response Letter for Neoadjuvant Pembrolizumab for High-Risk TNBC

March 29th 2021

The FDA has issued a complete response letter to Merck stating that regulatory decision for the supplemental biologics license application seeking approval for pembrolizumab for use in patients with high-risk, early-stage triple-negative breast cancer plus chemotherapy as neoadjuvant treatment, then continuing as a single agent as adjuvant treatment following surgery, should be deferred.

Adjuvant Nivolumab Takes Step Toward EU Approval in Muscle-Invasive Urothelial Carcinoma

March 29th 2021

The European Medicines Agency has validated its type II variation application for nivolumab as an adjuvant treatment for patients with surgically resected, high-risk muscle-invasive urothelial carcinoma.

Durvalumab Use Differs in Real-World, PACIFIC Stage III NSCLC Populations

March 27th 2021

More patients with stage III non–small cell lung cancer received sequential chemoradiation and delayed the time to durvalumab treatment in a real-world setting compared with those enrolled on the phase 3 PACIFIC trial.

EU Panel Recommends Atezolizumab for Frontline PD-L1–High Metastatic NSCLC

March 26th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of atezolizumab for use as a frontline treatment in adult patients with metastatic non–small cell lung cancer whose tumors have a high PD-L1 expression and no EGFR or ALK aberrations.

Portnoy Previews Immunotherapy Breakthroughs Shaking Up Frontline SCLC Paradigm

March 24th 2021

David C. Portnoy, MD, FACP, discusses ongoing studies examining immunotherapy and what is needed to move the needle forward in SCLC.

Immunotherapy Makes Waves in Gastroesophageal and Gastric Cancers

March 24th 2021

Namrata (Neena) Vijayvergia, MD, discusses the emerging role of immunotherapy in resectable and metastatic esophageal and gastric cancers, as well as key nuances that could complicate these agents’ utility in clinical practice.

FDA Approves Pembrolizumab for Advanced Esophageal or GEJ Cancer

March 22nd 2021

The FDA has approved pembrolizumab for use in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal carcinoma who are ineligible for surgical resection or definitive chemoradiation.

Atezolizumab Improves DFS Over BSC in PD-L1+ Resectable, Early-Stage NSCLC

March 22nd 2021

The PD-L1 inhibitor atezolizumab was found to improve disease-free survival over best supportive care when used as an adjuvant treatment in patients with PD-L1–positive, stage II-IIIA non–small cell lung cancer, meeting the primary end point of the phase 3 IMpower010 trial.

Chemo Reigns Control in Early-Stage TNBC, But Immunotherapy, ADCs Gain Ground in Metastatic Setting

March 20th 2021

Anthracyclines and taxanes remain a backbone in the early-stage setting of triple-negative breast cancer as further evaluations of immunotherapy in the neoadjuvant and adjuvant settings needs to be conducted—efforts that will continue to shape the treatment paradigm.

Tilsotolimod/Ipilimumab Fails to Improve ORR in PD-1 Refractory, Advanced Melanoma

March 19th 2021

The combination of tilsotolimod plus ipilimumab failed to improve objective response rate over ipilimumab alone in patients with advanced melanoma who are refractory to a PD-1 inhibitor, missing the primary end point of the phase 2 ILLUMINATE-301 trial.