Immuno-Oncology

Marjorie G. Zauderer, MD, previews some of the new approaches in mesothelioma.

Adjuvant pembrolizumab continued to showcase improved relapse-free survival over placebo in patients with resected high-risk stage II melanoma with 6 months of additional follow-up.

The FDA has accepted for review a biologics license application for the use of toripalimab in combination with gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma, and for use as a single agent in the second- or later-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma following platinum-containing chemotherapy.

Since Charu Aggarwal, MD, MPH, helped conduct the first phase 1 trial of pembrolizumab nearly a decade ago, she has been recognized as a pioneer in testing immunotherapy treatments for thoracic cancers.

The FDA has granted a fast track designation to the interleukin-2 variant immunotherapy nemvaleukin alfa for use in combination with pembrolizumab in the treatment of patients with platinum-resistant ovarian cancer.

The immuno-oncology company Agenus has made the decision to withdraw its biologic license application for the use of the PD-1 inhibitor balstilimab in patients with recurrent or metastatic cervical cancer who experienced disease progression on, or after, chemotherapy.

The European Commission has approved pembrolizumab plus chemotherapy for the frontline treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 expression combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The FDA has approved the VENTANA PD-L1 assay to assist in identifying which adult patients with stage II to IIIA non–small cell lung cancer whose tumors have PD-L1 expression on 1% or more of tumor cells are eligible to receive adjuvant atezolizumab following surgery and platinum-based chemotherapy.

The European Commission has approved nivolumab plus fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors have a PD-L1 combined positive score of 5 or higher.

The availability of chemoimmunotherapy combinations and targeted agents for common and rare mutations alike in non–small cell lung cancer has fostered discussions that might have been unthinkable just a decade or so ago.

Melissa L. Johnson, MD, discusses the promise of DS-7300 in small cell lung cancer and other advanced solid tumors.

The tide is starting to turn toward more effective frontline systemic therapies for patients with unresectable hepatocellular carcinoma as a result of the introduction of a novel immune-oncology combination.

Nivolumab plus cabozantinib continued to significantly improve overall response rate vs sunitinib in patients with previously untreated, advanced renal cell carcinoma, with meaningful response outcomes observed irrespective of dose modifications with cabozantinib and fewer responders in the doublet arm requiring subsequent treatment.

Robert J. Motzer, MD, spoke about the “exceptional” efficacy of the combination and how it fits into the evolving RCC treatment landscape.

Miranda Gogishvili, MD, discusses the rationale for examining cemiplimab plus platinum-doublet chemotherapy as a frontline treatment in patients with advanced NSCLC and key findings from the phase 3 EMPOWER-Lung 3 trial.

The European Medicines Agency has validated its marketing authorization application for the fixed-dose combination of relatlimab and nivolumab in the frontline treatment of adult and pediatric patients with advanced melanoma.

Hope S. Rugo, MD, discusses the final data from the phase 3 KEYNOTE-355 trial with pembrolizumab plus chemotherapy in patients with metastatic TNBC and the clinical impact on the treatment paradigm.

The addition of pembrolizumab to best supportive care resulted in a statistically significant improvement in overall survival vs BSC alone in Asian patients with advanced hepatocellular carcinoma who previously received treatment with sorafenib, meeting the primary end point of the phase 3 KEYNOTE-394 trial.

The FDA has accepted the supplemental biologics license applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy in the frontline treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Yelena Y. Janjigian, MD, further discusses the clinical significance of the FDA approval of nivolumab plus chemotherapy in the frontline treatment of patients with gastric cancer.

Dr. Dietrich discusses the latest developments with immunotherapy and targeted therapy in stage III non–small cell lung cancer.

The FDA has granted priority review to a biologics license application for the fixed-dose combination of relatlimab plus nivolumab for the treatment of adult and pediatric patients aged 12 years and older and weighing at least 40 kg who have unresectable or metastatic melanoma.

The frontline combination of nivolumab and ipilimumab continued to demonstrate improved overall survival across subgroups compared with standard chemotherapy at 3 years in patients with unresectable malignant pleural mesothelioma.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion of pembrolizumab plus chemotherapy in the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors have a PD-L1 combined positive score of 10 or higher and who have not previously received chemotherapy for metastatic disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab plus fluoropyrimidine and platinum-containing chemotherapy as frontline treatment for adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma with a PD-L1 combined positive score of 5 or higher.