The phase 3 CheckMate -67T trial found that a subcutaneous formulation of nivolumab met its co-primary pharmacokinetic end points compared with the intravenous formulation in clear cell renal cell carcinoma.
Findings from the CheckMate -67T (NCT04810078) reported that subcutaneous nivolumab (Opdivo) co-formulated with human hyaluronidase (rHUPH20) met its co-primary pharmacokinetic end points and key secondary end point of overall response rate (ORR) compared with intravenous (IV) nivolumab for the treatment of patients with clear cell renal cell carcinoma (ccRCC) who have received prior systemic therapies.1
Subcutaneous nivolumab demonstrated noninferior performance of time-averaged nivolumab serum concentration over 28 days and steady-state trough serum concentration compared with IV nivolumab. Subcutaneous nivolumab also showed a noninferior ORR compared with IV nivolumab.
“Intravenous [nivolumab] has helped transform the treatment of several solid tumor types over the past decade, but there remains a need for additional administration options to address treatment burden on patients and improve efficiencies in healthcare systems,” said Gina Fusaro, PhD, vice president, global program lead, Bristol Myers Squibb, in a press release. “We believe this new option, given as a single injection administered in less than 5 minutes, could transform the treatment experience for both patients and physicians.”1
The phase 3, open-label, randomized, noninferiority trial has an estimated enrollment of 454 patients. To be eligible, patients must have a histological confirmation of ccRCC, advanced RCC not amenable to curative or radiation therapy, metastatic RCC, received no more than 2 prior systemic therapies, intolerance or progression after last treatment regimen within 6 months of randomization, and Karnofsky performance score ≥ 70 at screening.
Patients are not eligible if they have untreated central nervous system metastases, a concurrent malignancy, active or suspected autoimmune disease, known HIV-positive status with an acquired immunodeficiency syndrome, or a serious or uncontrolled medical disorder. Patients who have received prior treatment with an anti-PD-1, anti-PD-LI, or anti-CTLA-4 antibody, or treatment with any live attenuated vaccine within 30 days of randomization are also not eligible to enroll in the study.2
Bristol Myers Squibb, nivolumab’s manufacturer, will complete a full analysis and evaluation of the available data from the CheckMate -67T and work with investigators to present results at an upcoming medical conference. Trial follow-up is ongoing and will assess additional secondary safety and efficacy end points.1
Key Takeaways From QOL and Use of Steroids With IO-Based RCC Regimens
May 6th 2024During a Case-Based Roundtable® event, Ulka Vaishampayan, MBBS, discussed the safety and quality-of-life data for ipilimumab plus nivolumab in patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More
Enhancing Precision in Immunotherapy: CD8 PET-Avidity in RCC
March 1st 2024In this episode of Emerging Experts, Peter Zang, MD, highlights research on baseline CD8 lymph node avidity with 89-Zr-crefmirlimab for the treatment of patients with metastatic renal cell carcinoma and response to immunotherapy.
Listen
Comparing Choices for IO/TKI Combinations in Advanced RCC
May 2nd 2024During a Case-Based Roundtable® event, Shilpa Gupta, MD, led a discussion on the combination of immunotherapy and tyrosine kinase inhibitors for patients with advanced renal cell carcinoma in the second article of a 2-part series.
Read More
Beyond the First-Line: Economides on Advancing Therapies in RCC
February 1st 2024In our 4th episode of Emerging Experts, Minas P. Economides, MD, unveils the challenges and opportunities for renal cell carcinoma treatment, focusing on the lack of therapies available in the second-line setting.
Listen
Sustained Treatment-Free Survival in RCC Seen With Nivolumab and Ipilimumab
April 30th 2024Nivolumab monotherapy plus salvage nivolumab/ipilimumab demonstrated superior treatment-free survival rates among patients with advanced renal cell carcinoma, especially in patients with favorable risk profiles.
Read More
Roundtable Roundup April: Renal Cell Carcinoma
April 27th 2024In separate, live virtual events, Arnab Basu, MD, MPH, and Robert J. Motzer, MD, asked participants which therapy they would choose for a patient with clear cell renal cell carcinoma (RCC) and why they would make that choice.
Read More