Regorafenib Doubles 12-Month Survival Compared with Lomustine in Recurrent Glioblastoma Multiforme

Regorafenib (Stivarga) improved overall survival (OS) and progression-free survival (PFS) compared with lomustine (Gleostine) for patients with glioblastoma multiforme (GBM) that recurred following surgery and treatment with the Stupp regimen, according to updated results presented in a poster at the 2018 ASCO Annual Meeting.

Patients with histologically-confirmed GBM and documented disease progression were randomly assigned to 160 mg of daily regorafenib in a 3 weeks on, 1 week off schedule (n = 59) or 110 mg/m² of lomustine every 6 weeks (n = 60). Treatment continued until disease progression or unacceptable toxicity. Investigators performed brain MRIs every 8 weeks according to the RANO criteria to assess tumor response.

Updated findings from the randomized, multicenter, controlled open-label phase II REGOMA trial (NCT02926222) showed that the overall survival (OS) rate at 12 months favored patients assigned to regorafenib 38.9% vs 15.0%. The median OS was 7.4 months (95% CI, 4.7-7.3) in the regorafenib group compared with 5.6 months (95% CI, 4.7-7.3) in the lomustine arm (HR, 0.5; 80% CI, 0.38-0.65; P = .0007).

Thirty-three (55.9%) patients in the regorafenib arm experienced at least 1 grade 3/4 treatment-related adverse event (TRAE) compared with 24 (40%) in the lomustine arm. Those results are identical to findings first presented at the ESMO 2017 Conference in September. There were no treatment-related deaths recorded in either set of data.

Regorafenib could be the next treatment for recurrent glioblastoma and this trial could be important for the FDA to approve this drug as a second-line treatment for glioblastoma. In April 2017, the FDA approved regorafenib for the treatment of patients with hepatocellular carcinoma (HCC) who previously received sorafenib (Nexavar), based on findings from the phase III RESORCE trial.

https://www.targetedonc.com/news/regorafenib-doubles-12month-survival-compared-with-lomustine-in-recurrent-gbm