Immuno-Oncology | Specialty

EU Panel Recommends Adjuvant Nivolumab for Select Esophageal, GEJ Cancers

June 25th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after previous neoadjuvant chemoradiotherapy.

ODAC Postpones Decision on Retifanlimab in Advanced Anal Cancer

June 24th 2021

In a 13 to 4 vote, the FDA’s Oncologic Drugs Advisory Committee chose to hold off on a decision regarding accelerated approval for retifanlimab for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or are intolerant of platinum-based chemotherapy.

Frontline Domvanalimab-Based Combos Elicit Encouraging ORRs in PD-L1–High NSCLC

June 24th 2021

The anti-TIGIT agent domvanalimab in combination with zimberelimab with or without etrumadenant demonstrated promising objective response rates when given as a first-line treatment in patients with metastatic non–small cell lung cancer who have a PD-L1 expression of 50% or higher.

Frontline Pembrolizumab Plus Chemo With or Without Bevacizumab Improves Survival in Cervical Cancer

June 22nd 2021

Pembrolizumab plus platinum-based chemotherapy with or without bevacizumab significantly improved overall survival and progression-free survival over the same platinum-based chemotherapy regimen with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer—irrespective of PD-L1 status.

Quadruplets, Immune-Based Regimens Slated to Expand the Frontline Myeloma Paradigm

June 18th 2021

Daratumumab-based quadruplet regimens and cutting-edge immune-based therapies are positioned to become potential standard options in frontline multiple myeloma treatment.

Frontline Sintilimab Plus Gemcitabine/Platinum Prolongs PFS in Squamous NSCLC

June 18th 2021

The addition of sintilimab to standard chemotherapy comprised of gemcitabine and platinum significantly improved progression-free survival with acceptable safety in previously untreated patients with advanced or metastatic squamous non–small cell lung cancer.

Adjuvant Nivolumab Improves DFS in High-Risk Muscle-Invasive Urothelial Cancer

June 14th 2021

Adjuvant nivolumab led to a significant improvement in disease-free survival compared with placebo in patients with high-risk muscle-invasive urothelial carcinoma following radical surgery, irrespective of PD-L1 expression level.

Patel Previews Collaborative Research Program With SD-101 in Uveal Melanoma

June 10th 2021

Dr. Patel discusses the significance of the new collaboration between The University of Texas MD Anderson Cancer Center and TriSalus™ Life Sciences.

AV-GBM-1 Cancer Vaccine Improves PFS in Newly Diagnosed Glioblastoma

June 8th 2021

The personalized cancer vaccine AV-GBM-1, developed by AIVITA Biomedical Inc., significantly improved progression-free survival over standard of care in patients with newly diagnosed glioblastoma.

Nivolumab Alone, With Ipilimumab Maintains Improved Outcomes in Advanced Melanoma in Long-Term Follow-Up

June 6th 2021

Nivolumab monotherapy, or in combination with ipilimumab, continued to demonstrate durable improvements in overall survival compared with ipilimumab alone in patients with previously untreated advanced melanoma.

Lifileucel/Pembrolizumab Elicits Encouraging ORR in ICI-Naïve Advanced Melanoma

June 4th 2021

The addition of lifileucel to pembrolizumab resulted in an overall response rate of 85.7% compared with pembrolizumab alone in patients with immune checkpoint inhibitor–naïve advanced melanoma.

Nivolumab/Ipilimumab Approved in Europe for Frontline Unresectable Malignant Pleural Mesothelioma

June 2nd 2021

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adults with unresectable malignant pleural mesothelioma.

Vidutolimod/Nivolumab Under Evaluation in PD-1–Refractory Advanced Melanoma

May 30th 2021

The safety and efficacy of the combination of vidutolimod and nivolumab is currently under investigation in patients with PD-1–refractory advanced melanoma.

Real-World Data Reflect Shorter Survival With Pembrolizumab in Older NSCLC Population

May 28th 2021

Pembrolizumab alone and in combination with chemotherapy was associated with shorter overall survival compared with the data demonstrated in the registrational clinical trials in older Medicare patients with advanced non–small cell lung cancer, providing real-world insight into the prognosis of older patients with NSCLC who are treated with immunotherapy.

Cemiplimab Granted Positive EU Opinion for Advanced NSCLC and Basal Cell Carcinoma

May 24th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of cemiplimab for use in 2 advanced cancers: non–small cell lung cancer and basal cell carcinoma.

High TMB Fails to Show Predictive Biomarker Potential for Checkpoint Inhibition Across Cancers

May 24th 2021

High tumor mutational burden was useful in predicting clinical responses to checkpoint inhibitors in patients with certain cancer subtypes; however, TMB-H failed to demonstrate utility as a biomarker for treatment with checkpoint inhibitors across all solid cancer types.

Frontline Pembrolizumab/Chemo Recommended for EU Approval for Select Esophageal or HER2-Negative GEJ Adenocarcinoma

May 24th 2021

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic esophageal carcinoma or HER2-negative gastroesophageal junction adenocarcinoma with PD-L1 positivity.

FDA Approval Sought for Penpulimab in Third-Line Metastatic Nasopharyngeal Carcinoma

May 24th 2021

A biologics license application has been submitted to the FDA for the PD-1 monoclonal antibody penpulimab for the third-line treatment of patients with metastatic nasopharyngeal carcinoma.

Frontline Tislelizumab Plus Chemo Improves PFS in Recurrent or Metastatic Nasopharyngeal Cancer

May 21st 2021

The combination of the anti–PD-1 tislelizumab and chemotherapy was found to significantly improve progression-free survival compared with chemotherapy alone in the frontline treatment of patients with recurrent or metastatic nasopharyngeal cancer, meeting the primary end point of the phase 3 RATIONALE 309 trial.

FDA Approves Adjuvant Nivolumab for Resected Esophageal or GEJ Cancer

May 20th 2021

The FDA has approved nivolumab for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease, in patients have received neoadjuvant chemoradiotherapy.