Jean-Yves Blay, MD, PhD, Comprehensive Cancer Centre of Lyon, France, discusses results from the LENVAGIST study which assessed the clinical efficacy of lenvatinib among patients with advanced gastrointestinal stromal tumors after tyrosine kinase inhibitor failure. Results demonstrated that lenvatinib provides promising clinical benefit in this patient population. 

Dr Blay first presented these results at the 2024 European Society of Medical Oncology (ESMO) Congress in Barcelona, Spain. 

Transcript: 

Hello, my name is Jean-Yves Blay, I'm a medical oncologist working in France in Lyon. I'm working mainly on sarcoma and today I will be presenting a study we are reporting at the sarcoma session, a randomized clinical trial comparing lenvatinib versus placebo plus best supportive care in patients with metastatic GIST who have failed other treatment, who have been progressing the on other treatments which are imatinib, sunitinib, regorafenib, and ripretinib. 

This was a study conducted between 2020 and 2024, we included a bit less than 80 patients. It was a randomized 1-to-1 allocation of the treatment and the patients who were randomized in the placebo arm had the opportunity to crossover to get the treatment at the end of the day. The primary end point of the study was progression-free survival. Overall, the study was well-balanced in terms of characteristics of the patient, prognostic factors, [and] clinical presentation. 

The primary end point, progression-free survival evaluated according to investigator assessment, is positive with a hazard ratio which is 0.45 and a significant reduction with the P-value inferior to .01, which demonstrates the superiority of lenvatinib. There is no difference yet for overall survival however, if you correct for the crossover, the trend is in favor of an improvement of survival with lenvatinib. In terms of response, there were few responses, only 5%, and only in the lenvatinib arm. This is actually quite often observed in late-line treatments of patients with advanced GIST. Interestingly, the crossover population who received lenvatinib after crossover post-placebo administration did have the same type of quality of response and progression-free survival. 

At the end of this study, what we can say is that lenvatinib is an active agent for the treatment of patients with advanced GIST who have progressed under the classical treatment. The toxicity of lenvatinib is acceptable in this context with no major differences across the 2 groups. This remains a hard-to-treat population of patients in which additional therapeutic options are needed.

Source: 

Cesne AL, Cropet C, Brahmi M, et al. LENVAGIST: A multicentre, comparative, placebo (P)-controlled, double-blinded, phase II study of the efficacy of lenvatinib (L) in patients with advanced GIST after failure of imatinib and sunitinib. Presented at 2024 ESMO Congress. September 13-17, 2024. Abstract LBA79