Immuno-Oncology | Specialty

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.

Cemiplimab Reduces Risk of Death by 31% Vs Chemotherapy in Advanced Cervical Cancer

May 13th 2021

The PD-1 inhibitor cemiplimab resulted in a 31% reduction in the risk of death compared with chemotherapy in patients with recurrent or metastatic cervical cancer who have progressed on chemotherapy.

Pembrolizumab Significantly Improves EFS as Neoadjuvant, Adjuvant Therapy in High-Risk, Early-Stage TNBC

May 13th 2021

Neoadjuvant pembrolizumab in combination with chemotherapy followed by adjuvant pembrolizumab monotherapy resulted in a significant improvement in event-free survival and pathologic complete response vs neoadjuvant chemotherapy alone in patients with high-risk, early-stage triple-negative breast cancer.

Off-the-Shelf Immunotherapy ADXS-504 Under Evaluation in Biochemically Recurrent Prostate Cancer

May 12th 2021

Columbia University Irving Medical Center will partner with Advaxis, Inc. to fund a phase 1 clinical trial that seeks to examine the novel off-the-shelf neoantigen immunotherapy agent ADXS-504 in patients with biochemically recurrent prostate cancer.

Building Off the Success Seen With Immunotherapy Strategies in NSCLC

May 7th 2021

Erminia Massarelli, MD, MS, PhD, shares key updates in immunotherapy and targeted treatment for patients with NSCLC

Future of SCLC Treatment Lies in Innovative Immunotherapy Combos

May 6th 2021

Ravi Salgia, MD, PhD, discusses pivotal trials that have shaken up the SCLC treatment paradigm and novel immunotherapy regimens under investigation.

FDA Grants Priority Review to Pembrolizumab/Lenvatinib for Advanced RCC and Endometrial Carcinoma

May 6th 2021

The FDA has granted priority review to applications that are seeking 2 approvals of pembrolizumab in combination with lenvatinib in advanced renal cell carcinoma and advanced endometrial carcinoma.

Dr. Osipov on the Role of Combination Immunotherapy Across Multiple Tumor Types

April 30th 2021

Arsen Osipov, MD, discusses the role of combination immunotherapy across multiple tumor types.

FDA Panel Supports Atezolizumab/Nab-Paclitaxel Combo for PD-L1+ Metastatic TNBC

April 27th 2021

The FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in support of maintaining the indication of atezolizumab in combination with nab-paclitaxel as a treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors are PD-L1 positive.

ODAC Hearings on 6 Immunotherapy Indications Set to Begin

April 26th 2021

The FDA’s Oncologic Drugs Advisory Committee is poised to move forward this week with a public review of 6 indications for immune checkpoint inhibitors granted under the agency’s accelerated approval process that later failed to reach thresholds for statistical significance for key end points in confirmatory clinical trials.

Entering an Era of Immunotherapy-Based Combinations for Metastatic RCC

April 18th 2021

The frontline treatment landscape of renal cell carcinoma is exploding with immunotherapy-based options.

Accelerating Advances in NSCLC Underscore the Importance of Accessibility

April 16th 2021

Jacob Sands, MD, discussed current approaches to the treatment of patients with early-stage and locally advanced non–small cell lung cancer.

NK Cell–Targeting Strategies Come Into Their Own

April 16th 2021

Although anticancer therapies that leverage T cells have commanded the most attention in the immuno-oncology era of the past decade, strategies based on natural killer cells have recently emerged as attractive approaches.

Chronic irAEs After Adjuvant Anti–PD-1 Therapy More Common Than Previously Recognized in High-Risk Resected Melanoma

April 15th 2021

Chronic immune-related adverse effects arising from adjuvant anti–PD-1 therapy in patients with high-risk melanoma are more common than previously recognized, and often persisted with longer follow-up.

Chemoimmunotherapy Prolongs Time to Disease Recurrence, But Work Remains to Deliver Durable Benefit in ES-SCLC

April 15th 2021

The combination of atezolizumab, carboplatin, and etoposide, as well as durvalumab, etoposide, and platinum chemotherapy, each have shown survival improvements vs chemotherapy alone as frontline therapy in patients with extensive-stage small cell lung cancer.

The Evolving Role of Immunotherapy in Metastatic Non–Small Cell Lung Cancer

April 15th 2021

This publication reviews the role of single-agent and dual immunotherapy for the treatment of metastatic non-small-cell lung cancer, recapping key insights from a scientific interchange & workshop.