A two-drug combination for treating advanced kidney cancer had sustained and durable clinical benefit in more than five years of follow-up, according to a study published Aug. 1 in Nature Medicine. 

The study reports final clinical data and biomarker analyses from the Phase 3 KEYNOTE-426 trial, which compared the drug combination pembrolizumab plus axitinib versus the single drug sunitinib for patients with previously untreated advanced clear cell renal cell carcinoma, the most common type of kidney cancer.

“KEYNOTE-426 was the first trial to combine a PD-1 inhibitor immunotherapy (pembrolizumab) with a VEGF receptor inhibitor antiangiogenic drug (axitinib) in the first-line setting for advanced renal cell carcinoma. It therefore has the longest follow-up duration among the various trials comparing these types of drug combinations,” said Brian Rini, MD, a medical oncologist at Vanderbilt-Ingram Cancer Center and the study’s lead and corresponding author. 

Immunotherapy drugs like pembrolizumab stimulate the immune system to kill tumor cells. VEGF receptor inhibitors like axitinib and sunitinib block angiogenesis — the development of blood vessels that tumors need to grow and spread. Pembrolizumab plus axitinib and other immunotherapy-antiangiogenic drug combinations are now standard first-line treatments for advanced kidney cancer. 

“Before the development of antiangiogenic drugs and immunotherapies, advanced renal cell carcinoma had a very poor prognosis. These drug combinations have dramatically improved treatment options and outcomes for patients,” said Rini, Thomas F. Frist Sr. Professor of Medicine. 

The first interim analysis of outcomes from KEYNOTE-426, published Feb. 16, 2019, in the New England Journal of Medicine, demonstrated that trial participants treated with pembrolizumab plus axitinib had longer overall and progression-free survival, and higher objective response rates compared to those taking sunitinib. The median follow-up was 12.8 months. 

Now, with a median follow-up of 67.2 months, the current analysis confirms and extends the interim analysis and provides valuable information about biomarkers that could help guide treatment decisions. 

The study in Nature Medicine reports that pembrolizumab plus axitinib had longer overall survival (47.2 months versus 40.8 months for sunitinib) and longer progression-free survival (15.7 months versus 11.1 months for sunitinib). The objective response rate was 60.6% for pembrolizumab plus axitinib and 39.6% for sunitinib. 

The researchers reported a variety of associations between the expression of biomarkers and outcomes (overall survival, progression-free survival, objective response rate). The biomarkers they evaluated included an 18-gene T-cell-inflamed expression profile, angiogenesis signature, and PD-1 ligand expression. 

“There is an unmet need for biomarkers that are predictive of patient outcomes following treatment with available first-line therapies for advanced renal cell carcinoma,” Rini said. “Although our analysis showed potential clinical utility of some RNA signatures in identifying patients who are likely to benefit the most from each treatment, further prospective clinical studies are needed.” 

Pembrolizumab plus axitinib is a first-line treatment option for patients with advanced renal cell carcinoma regardless of biomarker subtypes, he noted. 

The research was supported by the pharmaceutical company Merck Sharp & Dohme LLC, which played a role in the study design and conduct.

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A new prospective clinical trial with updated data on COVID-19 hospitalizations and deaths among patients with cancer confirms the importance of vaccination and sheds light on which conditions put patients most at risk. 

Patients who had been vaccinated had a 50% reduction in risk of hospitalization, according to data from the National Cancer Institute COVID-19 in Cancer Patients Study (NCCAPS) published July 17 in JAMA Oncology.

Death incidence was highest in patients with lymphoma, intermediate in patients with acute leukemia and lung cancer, and lowest in patients with other solid tumors or with blood cancers other than lymphoma. Patients who had undergone chemotherapy or who had a history of stroke, atrial fibrillation and pulmonary embolism were at higher risk for hospitalization. 

The finding that patients with lymphoma had the highest risk of death suggests a potential detrimental effect of B-cell-depleting therapy on COVID-19 outcomes, the study stated, but the authors noted that this hypothesis was confounded by the inherent immunosuppression in patients with lymphoma. 

“These results are important because they represent the only prospective clinical trial in patients with a recent diagnosis of COVID and an active cancer undergoing therapy,” said the study’s lead author Brian Rini, MD, Ingram Professor of Cancer Research and Thomas F. Frist Sr. Professor of Medicine. 

Rini is one of two principal investigators of NCCAPS. The other is Lorissa Korde, MD, with NCI’s Cancer Therapy Evaluation Program, who is the study’s senior author. Patients were accrued for the study between 2020 and 2022, and the statistical analysis took place between September 2024 and April 2025. 

The study involved 1,572 adult patients who had a COVID-19 diagnosis within 14 days while receiving active treatment for cancer or had a prior stem cell transplant or CAR-T cellular treatment therapy. In addition to outcomes, investigators analyzed COVID-19 therapies patients received and disruptions in cancer treatment. The most common type of disruption was a delayed cancer treatment. 

The majority of patients had already been accrued for analysis before the Food and Drug Administration gave emergency use authorization for the antiviral treatment nirmatrelvir with ritonavir, which is most commonly known by its brand name, Paxlovid. Of the patients who enrolled in the study after the first COVID-19 vaccine received FDA emergency use authorization, 41.5% were fully vaccinated. 

“These data provide a road map to protect the most vulnerable cancer populations not only from COVID, but from potential future pandemics,” Rini said. 

Patients hospitalized for COVID-19 within 90 days of enrollment accounted for 18.4% of the study group. Among the hospitalized patients, 23.4% were admitted to an intensive care unit.  

The study was funded in part by the Coronavirus Aid, Relief, and Economic Security (CARES) Act, and also by the National Cancer Institute National Clinical Trials Network, Experimental Therapeutics Clinical Trials Network, and Community Oncology Research Program grants via the U10 funding mechanism.  

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