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

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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

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.

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.

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

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

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 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.

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.

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.

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

Significant tumor necrosis was observed in 20% of patients with resectable hepatocellular carcinoma who received neoadjuvant treatment with cemiplimab-rwlc.

Neoadjuvant treatment with nivolumab combined with chemotherapy led to a significant improvement in pathologic complete response compared with chemotherapy alone in patients with resectable non–small cell lung cancer.

Sequential chemotherapy and immunotherapy became the preferred standard of care in patients with advanced urothelial carcinoma, based on findings from the phase 3 JAVELIN Bladder 100 trial.

Edward B. Garon, MD, discusses immunotherapy treatment considerations for patients with non–small cell lung cancer.










































