(Gastric/Colorectal Cancer) Stivarga + Opdivo Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
On April 28, 2020, Kohei Shitara published in the medical journal Journal of Clinical Oncology the results on efficacy and safety of Stivarga (regorafenib) plus anti-PD-1 antibody Opdivo (nivolumab) in patients with heavily pretreated advanced gastric or colorectal cancer from the Phase 1b REGONIVO/EPOC1603 clinical trial.
In this Phase 1b REGONIVO/EPOC1603 trial, heavily pretreated patients with advanced gastric or colorectal cancer received Stivarga (28-day cycle, regorafenib 80–160 mg once daily on days 1–21) plus Opdivo (2-week cycle, nivolumab 3 mg/kg). The primary endpoint was dose-limiting toxicity (DLT).
The trial was initiated based on the observation that immune checkpoint inhibitors, including anti-PD-1 antibodies, showed high anti-tumor activity in gastric and colorectal cancers, but resistance to checkpoint inhibitors also emerged. Preclinical studies confirmed high anti-tumor activity with the combination of regorafenib and anti-PD-1 antibodies.
A total of 50 patients were enrolled: 25 with gastric cancer and 25 with colorectal cancer. All had received at least two prior therapies; 96% had received anti-VEGFR antibodies and 7% had received checkpoint inhibitors previously.
Results: Among 50 patients, 3 experienced DLTs (the primary endpoint): Grade 3 perforation, papular rash, and proteinuria. The maximum tolerated dose of Stivarga was confirmed at 160 mg; no DLT was observed at 80 mg or 120 mg. Common adverse events included rash, proteinuria, and hand-foot syndrome.
In terms of efficacy, the objective response rate (ORR) was 40% (N=20). By cancer type: gastric cancer 44% (N=11), colorectal cancer 36% (N=9). Median progression-free survival (PFS) was 5.6 months for gastric cancer and 7.9 months for colorectal cancer.
Based on the REGONIVO/EPOC1603 results, Kohei Shitara concluded: In heavily pretreated patients with advanced gastric or colorectal cancer, once-daily Stivarga 80 mg plus anti-PD-1 antibody Opdivo showed good tolerability and promising anti-tumor activity.
Source: Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (J Clin Oncol. 2020 Apr 28:JCO1903296. doi: 10.1200/JCO.19.03296.)
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