Toni Choueiri, MD, explains what led to the phase 3 COSMIC-313 clinical trial.
Toni Choueiri, MD, director Lank Center for Genitourinary Oncology, director, Kidney Cancer Center, and senior physician at Dana-Farber Cancer Institute as well as a Jerome and Nancy Kohlberg chair and professor of Medicine, Harvard Medical School, explains what led to the phase 3 COSMIC-313 clinical trial.
In COSMIC-313, the cabozantinib (Cabometyx; cabo) will be combined with the immunotherapy doublet nivolumab (Opdivo; nivo) and ipilimumab (Yervoy; ipi) to treat patients with previously untreated advanced or metastatic renal cell carcinoma.
The study is being conducted on 840 patients across 167 locations in North America, South America, Europe, Asia, and Oceania.
0:07| First, the rationale of combining these 3 drugs ipilimumab the anti-CTLA 4 [agent] nivolumab, the PD-1 inhibitor and cabozantinib, the TKI that targets essentially VEGF receptor, but also targets other kinases involved in resistance, all of these drugs have approval in renal cell carcinoma. Cabozantinib [is approved] as a single agent in refractory disease, nivolumab as a single-agent in refractory disease, and cabozantinib as a first-line treatment in intermediate and poor risk [disease]. And ipilimumab’s role in renal cell cancer is first-line in combination with nivolumab. So naturally, you want to combine them all and there is some safety data that came from Dr. Apollo from the National Cancer Institute that showed that 3 of them could be combinable with cabozantinib at 40 milligrams a day.
1:10 | So, the rationale was to you know, look at the modern control arm and that will be nivolumab ipilimumab and cabozantinib. So, it's a phase 3 trial randomized to nivo/ipi/cabo versus nivo/ipi placebo with 1 to 1 randomization. The primary endpoint is progression-free survival and the usual suspects as secondary end points are response rate, safety, quality-of-life, and others.
Brain Cancer Awareness Month: Challenges and Innovations in Treatment
May 13th 2024In an interview with Targeted Oncology for Brain Cancer Awareness Month, Theodore Schwartz, MD, discussed the challenges of targeting brain tumors, emerging therapies, and strategies to overcome the blood-brain barrier.
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
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
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