Immuno-Oncology

The combination of bempegaldesleukin plus nivolumab continued to produce promising antitumor activity with favorable tolerability when used in the frontline treatment of patients with metastatic melanoma, according to findings from a phase 2 cohort of the phase 1/2 PIVOT-2 trial.

The combination of belapectin plus pembrolizumab has demonstrated early potential for disease control with acceptable tolerability in patients with metastatic melanoma and head and neck cancer.

During the past decade, a growing number of PD-1/PD-L1 inhibitors gained FDA approval to treat a wide range of cancer types. Their stimulatory counterparts also emerged as sought-after anticancer targets but have proved much more challenging to manipulate therapeutically.

The tumor-infiltrating lymphocyte therapy LN-145 was found to induce an objective response rate of 21.4% in patients with advanced or metastatic non–small cell lung cancer who had progressed following systemic therapy.

The novel combination comprised of rigosertib and nivolumab showed preliminary evidence of potential anticancer activity in patients with advanced metastatic KRAS-mutated non–small cell lung cancer.

Frontline pembrolizumab plus lenvatinib, and chemotherapy is being tested against chemotherapy alone in patients with advanced gastroesophageal adenocarcinoma, as part of the international, 2-part, phase 3 LEAP-015 trial.

The landscape of immunotherapy biomarkers is rapidly evolving, and future developments are likely to have an impact on patients and clinicians alike.

The immunotherapy Leukocyte interleukin followed by surgery and radiotherapy, without chemotherapy, significantly improved overall survival compared with standard of care alone in the treatment of patients with advanced primary squamous cell carcinoma of the head and neck.

The European Commission has approved the combination of nivolumab plus ipilimumab for use in adult patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer following previous fluoropyrimidine-based combination chemotherapy.

The European Commission has approved pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER2-negative gastroesophageal junction adenocarcinoma whose tumors have PD-L1 expression.

The combination of the targeted cancer vaccine galinpepimut-S plus nivolumab resulted in a median overall survival of 35.4 weeks in patients with macroscopic deposits of malignant pleural mesothelioma who had received treatment for at least 1 month.

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.

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.

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.

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.

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

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 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.

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 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.

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.

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.

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

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.

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 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.