Immuno-Oncology

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of nivolumab as neoadjuvant therapy in combination with platinum-based chemotherapy for patients with resectable non–small cell lung cancer at high risk of recurrence and tumor cell PD-L1 expression of at least 1%.

The National Medical Products Administration has accepted the supplemental new drug application seeking the approval of toripalimab in combination with nab-paclitaxel in patients with untreated metastatic or recurrent triple-negative breast cancer and a PD-L1 combined positive score of at least 1.

The combination of GEN-002 and avelumab elicited responses in patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to findings from an interim analysis of an ongoing phase 2 trial.

Roger Li, MD, discusses how the synergistic mechanism of pembrolizumab plus CG0070 could address unmet needs in BCG-unresponsive NMIBC, safety and efficacy data for the combination from the CORE-001 trial, and how those data support planned research efforts for CG0070 in this space.

John Michael "JM" Bryant, MD, expands on the results of the interim analysis of the single-center, single-arm phase 2 trial for patients with grade group 5 prostate cancer treated with the combination of nivolumab and standard of care.

Karen L. Reckamp, MD, MS, discusses the rationale for evaluating patients with early-stage NSCLC who received adjuvant atezolizumab as part of the LCMC3 study and explains the significance and limitations of data from a retrospective analysis.

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.