KEY TAKEAWAYS
- The Phase II CANTATA study, bearing the trial code NCT03428217, is a randomized, placebo-controlled clinical trial with 444 participants.
- The study aimed to examine the effectiveness and tolerability of a combination of two drugs, telaglenastat, and cabozantinib, in treating metastatic RCC.
- The study’s primary outcome measure was PFS assessed by the Independent Radiology Committee (IRC); the median PFS of both arms of the study were similar.
- The study also demonstrated that the combination was well-tolerated, and adverse events aligned with the recognized risks of both agents.
The Phase II CANTATA trial compared telaglenastat, cabozantinib (Tela + Cabo), and placebo and cabozantinib (Pbo + Cabo) for their effectiveness and tolerability. The participants in the study had progressed on one to two prior lines of therapy, including one or more antiangiogenic therapies or nivolumab + ipilimumab.
Randomized patients (1:1) received oral cabozantinib (60 mg daily) with either telaglenastat (800 mg twice daily) or a placebo. A total of 444 patients were randomly assigned, 221 to Tela + Cabo and 223 to Pbo + Cabo (median [range] age, 62 [29-83] years; 68 [30%] women and 155 [70%] males).
A total of 276 (62%) patients had previously received immune checkpoint inhibitors, including 128 who had also gotten nivolumab and ipilimumab, and 93 of them had not. Compared to Pbo + Cabo, Tela + Cabo had a median progression-free survival of 9.2 months as opposed to 9.3 months (HR, 0.94; 95% CI, 0.74-1.21; P =0.65). In addition, with Tela + Cabo, the ORR was 31% (69 of 221) compared to Pbo + Cabo’s 28% (62 of 223).
The incidence of treatment-emergent adverse events (TEAE) was comparable across groups. About 160 patients (71%) with Tela + Cabo and 172 patients (79%) with Pbo + Cabo experienced grade 3 to 4 TEAEs, which included diarrhea (15% vs. 13%) and hypertension (17% vs. 18%). About 23 patients (10%) receiving Tela + Cabo and 33 patients (15%) receiving Pbo + Cabo had their treatment with Cabozantinib stopped because of adverse events.
In this randomized clinical study, cabozantinib’s effectiveness in treating metastatic RCC was not improved by telaglenastat. However, with adverse events (AEs) in line with the recognized risks of both agents, Tela + Cabo was well tolerated.
Source: https://jamanetwork.com/journals/jamaoncology/article-abstract/2795979
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03428217
Tannir, N. M., Agarwal, N., Porta, C., Lawrence, N. J., Motzer, R., McGregor, B., Lee, R. J., Jain, R. K., Davis, N., Appleman, L. J., Goodman, O., Jr, Stadler, W. M., Gandhi, S., Geynisman, D. M., Iacovelli, R., Mellado, B., Sepúlveda Sánchez, J. M., Figlin, R., Powles, T., Akella, L., Orford, K., Escudier, B. (2022). Efficacy and Safety of Telaglenastat Plus Cabozantinib vs Placebo Plus Cabozantinib in Patients With Advanced Renal Cell Carcinoma: The CANTATA Randomized Clinical Trial. JAMA oncology, 8(10), 1411–1418. https://doi.org/10.1001/jamaoncol.2022.3511
