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Regorafenib offers survival benefit for patients with pre-treated gastric cancer

Presented by
Prof. Nick Pavlakis, University of Sydney, Australia
ASCO GI 2023

Regorafenib outperformed placebo in terms of overall survival in patients with refractory, advanced gastric or oesophago-gastric junction cancer (AGOC) in the phase 3 INTEGRATE IIa trial, providing a new treatment option for this patient population. The phase 3 INTEGRATE IIb trial is currently ongoing to compare regorafenib plus nivolumab with chemotherapy in patients with refractory AGOC.

“The treatment options for patients with pre-treated AGOC are limited,” said Prof. Nick Pavlakis (University of Sydney, Australia) at the start of his presentation [1]. “However, regorafenib showed promising anti-tumour activity in a phase 2 trial [2].” After these findings had been reported, a phase 3 study was designed to test regorafenib against placebo. The INTEGRATE IIa trial (NCT02773524) randomised 251 patients with AGOC who had received at least 2 prior lines of therapy 2:1 to regorafenib, 160 mg, once daily at days 1 to 21 of a 28-day cycle, or placebo [3]. The primary endpoint was the overall survival (OS).

Patients in the regorafenib arm had an OS benefit compared with patients in the placebo arm (HR 0.68; 95% CI 0.52–0.90; P=0.006; see Figure) . The corresponding 12-month OS rates were 19% and 6%, respectively. Prof. Pavlakis mentioned that there were no significant differences among pre-defined subgroups. Furthermore, the progression-free survival results confirmed the OS results, demonstrating a benefit for patients on regorafenib over patients on placebo (HR 0.53; 95% CI 0.40–0.70; P<0.0001). Interestingly, patients receiving regorafenib displayed a significant delay in the deterioration of their global quality-of-life compared with patients receiving placebo (P=0.0043). According to Prof. Pavlakis, the safety profile of regorafenib was comparable with that of previously reported studies on this agent.

Figure: Overall survival of regorafenib versus placebo [3]

In conclusion, regorafenib improved the health outcomes in patients with pre-treated AGOC, presenting itself as a new treatment option for the population. The agent is further assessed in combination with nivolumab against chemotherapy in an estimated 450 patients with AGOC who failed on at least 2 prior lines of therapy in the INTEGRATE IIb trial (NCT04879368).

  1. Smyth EC, et al. Lancet. 2020;396:635–648.
  2. Pavlakis N, et al. JCO. 2016;34:2728–2735.
  3. Pavlakis N, et al. INTEGRATE IIa: A randomised, double-blind, phase III study of regorafenib versus placebo in refractory advanced gastro-oesophageal cancer (AGOC)—A study led by the Australasian Gastro-intestinal Trials Group (AGITG). Late-breaking abstract 294, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.

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