Immuno-Oncology

The FDA has lifted a partial clinical hold on the phase 1 NEON-2 trial investigating the use of davoceticept in combination with pembrolizumab in adult patients with advanced solid tumors or lymphoma.

The combination of nivolumab and axitinib achieved meaningful responses in treatment-naïve advanced renal cell carcinoma, according to results from a phase 1/2 trial (NCT03172754) presented at the 2022 Genitourinary Cancers Symposium.

A biologics license application seeking the approval of N-803 in combination with Bacillus Calmette-Guérin in patients with BCG-unresponsive, non–muscle invasive bladder cancer carcinoma in situ with or without Ta or T1 disease has been submitted to the FDA.

Nicoletta Colombo, MD, PhD, discusses the practice-changing data to emerge from KEYNOTE-826 and the next steps for the pembrolizumab plus chemotherapy with or without bevacizumab regimen in patients with cervical cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of pembrolizumab for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection.

The combination of intratumoral vidutolimod and intravenous pembrolizumab demonstrated promising clinical activity in patients with PD-1 refractory melanoma.

Stereotactic body radiation therapy in combination with nivolumab and ipilimumab demonstrated clinically meaningful antitumor activity with a favorable toxicity profile in difficult-to-treat patients with refractory metastatic pancreatic cancer, although the contribution of SBRT is still unclear.

The combination of nivolumab plus ipilimumab was not found to significantly improve overall survival over standard-of-care chemotherapy when used in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma with a PD-L1 expression of 1% or higher.

According to longer follow-up data from the phase 3 CheckMate 274 trial, patients with high-risk, muscle-invasive urothelial carcinoma continued to experience clinically meaningful improvements in disease-free survival when treated with adjuvant nivolumab vs placebo.

The combination of sotigalimab and nivolumab elicited durable responses with a reasonable safety profile in patients with melanoma who were refractory to anti–PD-1 therapy, according to data from a phase 2 trial.

The combination of cabozantinib plus nivolumab demonstrated promising objective response rates in patients with non–clear cell renal cell carcinoma with prominent papillary features.

The addition of nivolumab to trastuzumab deruxtecan did not result in a marked clinical benefit in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

Igor Puzanov, MD, MSCI, FACP, discusses the adverse effects associated with immunotherapy and how to manage them.

The addition of pembrolizumab to chemotherapy led to significant survival benefits without substantial deterioration in health-related quality of life among patients with treatment-naïve, PD-L1–positive advanced triple-negative breast cancer according to results from the phase 3 KEYNOTE-355 trial.

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.