Immuno-Oncology

Health Canada has approved the combination of cemiplimab and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non–small cell lung cancer without EGFR, ALK, or ROS1 aberrations who are not candidates for definitive chemoradiation.

Treatment with pembrolizumab monotherapy resulted in stable long-term disease-free survival rates in patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle-invasive bladder cancer.

Bradley A. McGregor, MD, discusses the clinical significance of the updated COSMIC-021 data, how these findings support the continued investigation of IO/TKI combinations in non–clear cell renal cell carcinoma, and other efforts underway to better care for patients with varying histological subtypes of the disease.

Treatment with nivolumab plus ipilimumab and a subsequent TKI was effective in patients with metastatic clear cell renal cell carcinoma.

The European Medicines Agency has validated a type II variation for potential approval of dostarlimab in combination with carboplatin and paclitaxel for the treatment of patients with mismatch repair–deficient/microsatellite instability–high primary advanced or recurrent endometrial cancer.

The PD-L1 inhibitor sugemalimab produced durable responses with a tolerable safety profile in patients with relapsed/refractory natural killer/T-cell lymphoma, according to findings from a preplanned primary analysis of the multicenter, single-arm, phase 2 GEMSTONE-201 trial.

Joshua G. Cohen, MD, FACOG, FACS, expands on the role of PARP inhibitors in the recurrent and up-front settings in ovarian cancer, and the clinical significance of the RUBY and NY-GY018 trials in endometrial cancer.

A long-term post-hoc analysis from the JAVELIN Bladder 100 trial demonstrated that first-line maintenance avelumab elicited similar overall survival and progression-free survival benefits vs best supportive care alone in patients with advanced urothelial carcinoma.

Adjuvant pembrolizumab prolonged disease-free survival and distant metastasis–free survival vs placebo in patients with clear cell renal cell carcinoma at increased risk of recurrence after nephrectomy, irrespective of UCLA Integrated Staging System risk category and disease stage.

Perioperative durvalumab plus neoadjuvant platinum-based chemotherapy demonstrated a statistically significant improvement in pathologic complete response and event-free survival vs placebo plus chemotherapy in patients with resectable non–small cell lung cancer.

mRNA-4157 in combination with pembrolizumab improved recurrence-free survival compared with pembrolizumab alone when used as an adjuvant treatment in patients with resected high-risk melanoma, regardless of tumor mutational burden.

Investigators of an ongoing phase 1a/1b multicohort trial are studying whether addition of adaptive immune activators increases the benefit derived from anti–PD-1 antibodies in multiple tumor types.

Jung-Yun Lee, MD, PhD, discusses the TRU-D trial within the context of prior negative trials to emphasize the need for more effective therapies in advanced-stage ovarian cancer, highlights key findings from TRU-D, and elaborates on future steps for this research.

Despite a high-profile clinical disappointment, the TIGIT immune checkpoint remains an important target for anticancer therapy, with research programs testing novel agents moving forward in non–small cell lung cancer and a range of other tumor types.

Ramez N. Eskander, MD, highlights the potential implications of the NRG GY018 trial as well as safety and efficacy results from the trial.

The sequential combination of THIO plus cemiplimab did not lead to any dose-limiting toxicities or significant treatment-related adverse effects in patients with advanced non–small cell lung cancer.

The European Medicines Agency has granted Priority Medicines scheme designation to the personalized cancer vaccine mRNA-4157/V940 and pembrolizumab for use as adjuvant treatment in patients with high-risk, stage III or IV melanoma following complete resection.

The phase 3 LEAP-003 and LEAP-017 trials evaluating pembrolizumab plus lenvatinib did not meet their primary end points of overall survival in select patients with unresectable or metastatic melanoma and metastatic colorectal cancer, respectively.

In an era of genomics, proteomics, and immunology a biomarker as simple as anatomy may be useful in terms of predicting responses in patients with colorectal cancer.

Combining the immune checkpoint inhibitor dostarlimab-gxly with standard-of-care chemotherapy elicited an increase in progression-free survival rates compared with chemotherapy alone for patients with primary advanced or recurrent endometrial cancer.

The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev) plus pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.

Treatment with eftilagimod alpha plus pembrolizumab resulted in tumor shrinkage and a tolerable safety profile in patients with anti–PD-1/PD-L1–resistant non–small cell lung cancer.

The combination of tusamitamab ravtansine and pembrolizumab with or without chemotherapy generated responses and was well tolerated when used as first-line treatment for patients with CEACAM5-positive nonsquamous non–small cell lung cancer.

Frontline cemiplimab plus chemotherapy improved overall survival and progression-free survival compared with investigator’s choice of chemotherapy for patients with PD-L1–positive non–small cell lung cancer that has metastasized to the brain.

BDC-1001 monotherapy and in combination with nivolumab generated antitumor activity with acceptable tolerability in patients with advanced HER2-expressing solid tumors, according to topline data from the dose-escalation portion of a phase 1 trial.

The addition of cemiplimab to platinum-doublet chemotherapy continued to provide a clinically meaningful and statistically significant improvement in clinical benefit over chemotherapy alone in patients with advanced non–small cell lung cancer, irrespective of histology or PD-L1 expression level.

Neoadjuvant nivolumab plus chemotherapy produced a long-term event-free survival benefit vs chemotherapy alone in patients with resectable non–small cell lung cancer, independent of whether patients underwent minimally invasive surgery or thoracotomy or complete or partial resection of the lung.

Nearly 40 years after the first cytokine-based therapy was approved for the treatment of patients with hairy cell leukemia, investigators are taking a fresh look at ways to leverage these signaling proteins to enhance immunotherapies and vaccines in other cancers.

The FDA has granted full approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high or mismatch repair–deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options.

Brian Mitzman, MD, FACS, FCCP, discusses the emergence of immunotherapy as a treatment option for patients with early-stage non–small cell lung cancer.