Immuno-Oncology

Pembrolizumab with or without chemotherapy resulted in a numerically longer overall survival benefit vs cetuximab plus chemotherapy in patients with head and neck squamous cell carcinoma and a PD-L1 combined positive score (CPS) between 1 and 19, but did not improve survival in the subset with a PD-L1 CPS of less than 1.

The FDA is seeking the approval of toripalimab plus gemcitabine and cisplatin in the frontline treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma and for use as a monotherapy in the second-line and later treatment of those with recurrent or metastatic disease.

Novel strategies to modulate the microbiota are now an area of robust investigation

The combination of tislelizumab and chemotherapy resulted in a significant improvement in overall survival compared with chemotherapy alone in patients with locally advanced, recurrent or metastatic esophageal squamous cell carcinoma, irrespective of PD-L1 expression.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of neoadjuvant pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab alone after surgery for adult patients with locally advanced or early-stage triple-negative breast cancer who are at a high risk for recurrence.

The IL-2 variant immunotherapy nemvaleukin alfa elicited responses and demonstrated safety as a single agent and in combination with pembrolizumab in patients with advanced renal cell carcinoma.

The FDA has granted an orphan drug designation to the PD-1 inhibitor toripalimab as a potential therapeutic option for patients with small cell lung cancer.

The addition of novel anti–LAG-3 antibody relatlimab-rmbw to antiPD-1 antibody nivolumab offers treatment-naïve patients with unresectable or metastatic melanoma an efficacious and tolerable immunotherapy treatment option.

Nektar Therapeutics and Bristol Myers Squibb have announced the decision to end the global clinical development program for the combination of bempegaldesleukin and nivolumab based on findings from preplanned analyses of 2 late-stage clinical trials.

The dual immunotherapy combination of nivolumab and ipilimumab elicited encouraging and durable responses with acceptable safety in patients with advanced or metastatic tumor mutational burden–high solid tumors that were refractory to standard therapies, meeting the primary end points of the phase 2 CheckMate-848 trial.

The European Commission has approved the dual immunotherapy combination of nivolumab and ipilimumab for use in the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma who had a PD-L1 expression of 1% or higher on tumor cells.

The European Commission has approved nivolumab in combination with fluoropyrimidine- and platinum-based chemotherapy for the frontline treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma with a PD-L1 expression of 1% or higher on tumor cells.

The combination of eftilagimod alpha and pembrolizumab was found to produce an encouraging early overall survival rate of 73% at the 6-month landmark when used as second-line treatment in patients with PD-1/PD-L1–refractory, metastatic non–small cell lung cancer, according to data from part B of the phase 2 TACTI-002 trial.

The addition of the anti-TIGIT immunotherapy tiragolumab to atezolizumab plus carboplatin/etoposide failed to significantly improve progression-free survival over atezolizumab/chemotherapy alone when used in the frontline treatment of patients with extensive-stage small cell lung cancer, missing the co-primary end point of the phase 3 SKYSCRAPER-02 trial.

The European Medicines Agency has validated its type II variation application for nivolumab in combination with chemotherapy for use in the neoadjuvant treatment of patients with unresectable stage IB to IIIA non–small cell lung cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer who have a PD-L1 combined positive score of 1 or higher.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended pembrolizumab for the treatment of adult patients with a variety of microsatellite instability-high or mismatch repair deficient tumors.

James P. Allison, PhD, a Nobel Laureate and Giants of Cancer Care® award winner, will head up the new James P. Allison Institute at The University of Texas MD Anderson Cancer Center.

Durvalumab given concurrently with chemoradiation was not found to significantly improve progression-free survival vs chemoradiation alone in patients with locally advanced cervical cancer, missing the primary end point of the phase 3 CALLA trial.

The FDA has issued a complete response letter to the biologics license application seeking the approval of sintilimab injection in combination with pemetrexed and platinum chemotherapy in the frontline treatment of patients with nonsquamous non–small cell lung cancer.

Hussein A. Tawbi, MD, PhD, discusses the recent FDA approval of relatlimab/nivolumab in metastatic melanoma, the significance of the regulatory decision, and potential avenues for further exploration of the regimen.

Temozolomide priming followed by the combination of low-dose ipilimumab and nivolumab may produce durable clinical benefit in microsatellite stable and MGMT-silenced metastatic colorectal cancer.

The FDA has approved pembrolizumab for use as a single agent in the treatment of patients with advanced endometrial carcinoma that is microsatellite instability–high or mismatch repair deficient, and who experienced disease progression following previous systemic therapy in any setting and are not candidates for curative surgery or radiation.

Patient-reported outcome data support a favorable benefit/risk profile for the combination of pembrolizumab plus chemotherapy, with or without bevacizumab, in patients with persistent, recurrent, or metastatic cervical cancer.

The FDA has granted a fast track designation to the novel immunostimulant 7HP349 for use in combination with a CTLA-4 inhibitor in patients with unresectable or metastatic malignant melanoma in whom a PD-L1 inhibitor has failed.

The Ministry of Health, Labour, and Welfare has approved Guardant360 CDx to perform comprehensive genomic profiling in patients with advanced solid cancers.

The fixed-dose combination of relatlimab and nivolumab continued to demonstrate a consistent progression-free survival benefit, showcased a clinically meaningful improvement in overall survival, and elicited a higher objective response rate than nivolumab alone in previously untreated patients with metastatic or unresectable melanoma.

The phase 3 KEYLYNK-001 trial evaluating the combination of pembrolizumab and olaparib in patients with metastatic castration-resistant prostate cancer who progressed following chemotherapy and either abiraterone acetate or enzalutamide will be discontinued for futility.

The combination of cabozantinib and atezolizumab was not found to result in an improvement nor a detriment in overall survival vs sorafenib when used in previously untreated patients with advanced hepatocellular carcinoma, according to data from the phase 3 COSMIC-312 trial.

The addition of bempegaldesleukin to nivolumab did not significantly improve progression-free survival, objective response rate, or overall survival vs nivolumab alone in the frontline treatment of patients with unresectable or metastatic melanoma, missing the primary end points of the phase 3 PIVOT IO-001 trial.