Not only for MSI-H! A combination of two approved drugs is in Phase III trial for MSS colorectal cancer

Background –

The combination of regorafenib (Stivarga) and nivolumab (Opdivo) will be compared with regorafenib alone in a phase III trial of patients with microsatellite stable (MSS) colorectal (CRC), cancer, following encouraging phase Ib findings of the REGONIVO study.

In this early-phase study of 50 evaluable patients, results of which were presented at the 2019 ASCO Annual Meeting. The combination led to an overall response rate (ORR) of 40% in patients with CRC or gastric cancer, the majority of which were MSS tumors. The disease control rate (DCR) was 88%.

Approval status –

Regorafenib is currently approved by the FDA as a second-line treatment for patients with advanced CRC who progressed on prior therapy.

The FDA approved nivolumab in August 2017 for the treatment of adult and pediatric patients with microsatellite instability-high or mismatch repair deficient metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

REGONIVO (EPOC1603) trial –

Fifty patients with advanced or metastatic gastric cancer (25 patients) or CRC (25 patients) were evaluated. The median number of prior therapies was 3.

98% of patients had MSS tumors and 41% of patients had PD-L1–positive disease.
When stratified by tumor type, patients with CRC had an ORR of 36%, including 33% in those with MSS disease.

The ORR was 44% in patients with gastric cancer, all of whom had MSS tumors.
The median time to disease progression under the treatment (PFS), for those with CRC and gastric cancer were 6.3 months and 5.8 months, respectively.

Safety –

Regarding safety, all-grade adverse events (AEs) occurred in 100% of patients. Severe AEs included hand-foot syndrome (10%), hypertension (4%), rash (12%), proteinuria (12%), liver dysfunction (6%), diarrhea (2%), and decrease in platelet count (2%).

Is this new trial attractive?

With such positive early results, it seems that the study is not attractive to patients who can get the drugs outside the study, through health insurances for example, making sure they will receive the combination rather than a single drug, regorafenib.

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