(Gastric/Colorectal Cancer) Stivarga + Opdivo Effective? (Part 2)
Medical Supporter — Information Notice
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 efficacy and safety results of Stivarga (regorafenib) plus anti-PD-1 antibody Opdivo (nivolumab) in patients with previously treated advanced gastric or colorectal cancer from the REGONIVO/EPOC1603 Phase 1b clinical trial.
The REGONIVO/EPOC1603 Phase 1b trial treated previously treated patients with advanced gastric or colorectal cancer over a 28-day cycle with Stivarga (once daily on days 1–21 at 80–160 mg) plus Opdivo (3 mg/kg on a 2-week cycle). The primary endpoint was dose-limiting toxicity (DLT).
The trial was initiated because immune checkpoint inhibitors, including PD-1 antibodies, showed high anti-tumor activity in gastric and colorectal cancers, yet resistance to these inhibitors remained possible. Preclinical studies confirmed high anti-tumor activity for Stivarga + anti-PD-1 antibody combinations, which led to the initiation of this trial.
Of the 50 patients enrolled, background data: gastric cancer 25, colorectal cancer 25; at least two prior lines of therapy; prior anti-VEGFR antibody therapy 96%, prior immune checkpoint inhibitor therapy 7%.
Results: Among 50 patients, 3 experienced DLT-related adverse events: perforation, maculopapular rash, and proteinuria. The DLT for Stivarga was confirmed at 160 mg; no DLT was observed at 80 mg or 120 mg. Grade 3 or higher adverse events observed in most patients included rash, proteinuria, and hand-foot syndrome.
For efficacy, the ORR was 40% (N=20). By cancer type: gastric cancer 44% (N=11) / colorectal cancer 36% (N=9). Median PFS: gastric cancer 5.6 months / colorectal cancer 7.9 months.
Based on REGONIVO/EPOC1603 results, Kohei Shitara concluded: In previously treated patients with advanced gastric or colorectal cancer, once-daily Stivarga 80 mg + 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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