Immuno-Oncology

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.

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.

Frontline immunotherapy resulted in improved progression-free survival and overall survival compared with sunitinib in patients with advanced renal cell carcinoma; however, determining the benefit in those with favorable-risk disease must be examined further.

Nivolumab followed by tumor-infiltrating lymphocyte therapy and maintenance nivolumab demonstrated a suitable safety profile and antitumor activity in patients with metastatic non–small cell lung cancer.

It’s imperative to stay diligent of the immune-related adverse events that patients with cancer may experience from checkpoint inhibitors and other immunotherapy agents, especially with regards to treatment continuation and keeping hospitalizations low.

Jonathan W. Goldman, MD, discusses the significance of the phase 3 CASPIAN and IMpower133 trials in small cell lung cancer and efforts made to optimize molecular testing.

The FDA has granted an accelerated approval to dostarlimab-gxly for the treatment of adult patients with mismatch repair-deficient recurrent or advanced solid tumors, as determined by an FDA-approved test, who have progressed on or following previous treatment and who have no satisfactory alternative options.

The European Medicines Agency has validated its Type II Variation Marketing Authorization Applications for nivolumab plus ipilimumab and nivolumab plus fluoropyrimidine- and platinum-containing chemotherapy as frontline options for adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Stephen M. Ansell, MD, PhD, discusses recent progress made with non–CAR T-based approaches in the non-Hodgkin lymphoma treatment paradigm, opportunities for sequencing available options, and ongoing efforts that are picking up momentum.

The COVID-19 pandemic had a relatively limited effect on immuno-oncology research, according to results from the Association of Community Cancer Centers fourth annual analysis of the IO landscape.

The subspecialty of cardio-oncology has grown in recent years as improved cancer survival rates have expanded the population of long-term survivors with heightened risk of cardiovascular disease and drawn more attention to the need for preventive strategies and disease management.

The FDA has granted a fast track designation to nemvaleukin alfa as a potential therapeutic option for patients with mucosal melanoma.

The European Commission has approved nivolumab for use as an adjuvant treatment in adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease after neoadjuvant chemoradiation.

The addition of pembrolizumab to chemotherapy resulted in a statistically significant and clinically meaningful improvement in overall survival vs chemotherapy alone in patients with metastatic triple-negative breast cancer whose tumors had a PD-L1 expression of a combined positive score of 10 or higher, meeting the primary end point of the phase 3 KEYNOTE-355 trial.

The FDA has approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Roche Registration GmbH has withdrawn its application to extend the use of atezolizumab to the treatment of patients with early or locally advanced triple-negative breast cancer in Europe.

The FDA has issued a complete response letter to Incyte Corporation stating that it cannot approve the biologics license application for retifanlimab for use in adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy, in its present form.

Bristol Myers Squibb has decided to voluntarily withdraw the indication for nivolumab as a monotherapy for patients with hepatocellular carcinoma who were previously treated with sorafenib from the US market.

The FDA has granted a regular approval to pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high or mismatch repair deficient, who have disease progression after previous systemic therapy in any setting, and who are not candidates for curative surgery or radiation.

The FDA has granted an orphan drug designation to alrizomadlin as a potential therapeutic option for patients with stage IIB-IV melanoma.

Nivolumab plus ipilimumab did not significantly improve overall survival over the EXTREME regimen in the frontline treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck, missing the primary end points of the phase 3 CheckMate-651 trial.

Neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant single-agent pembrolizumab was found to significantly improve event-free survival over neoadjuvant chemotherapy followed by adjuvant placebo in patients with high-risk, early-stage triple-negative breast cancer.

The combination of atezolizumab plus bevacizumab elicited encouraging, durable responses in patients with advanced malignant peritoneal mesothelioma, irrespective of tumor mutational burden and PD-L1 expression status.