The Food and Drug Administration (FDA) has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

The approval is supported by data from the multicenter, open-label, phase 3 BEACON CRC trial (ClinicalTrials.gov Identifier: NCT02928224) in adult patients with BRAF V600E mutation-positive metastatic colorectal cancer with disease progression after 1 or 2 prior regimens. All patients received cetuximab 400mg/m2 intravenously for the first dose followed by 250mg/m2 weekly. Patients were randomly assigned 1:1:1 to receive: cetuximab plus encorafenib 300mg orally once daily (n=220), cetuximab plus binimetinib and encorafenib, or cetuximab with irinotecan or cetuximab with FOLFIRI (n=221; control arm). 

Findings showed that cetuximab plus encorafenib demonstrated a statistically significant improvement in overall survival compared with the control arm (8.4 months [95% CI, 7.5-11.0] vs 5.4 months [95% CI, 4.8-6.6]; hazard ratio 0.60; 95% CI, 0.45-0.79; P =.0003). Overall response rate was 20% (95% CI, 13-29) with cetuximab plus encorafenib compared with 2% (95% CI, 0-7) with the active comparator (P <.0001). Median progression-free survival was 4.2 months (95% CI, 3.7-5.4) and 1.5 months (95% CI, 1.4-1.7) for the cetuximab plus encorafenib and control arms, respectively (hazard ratio 0.40; 95% CI, 0.31-0.52; P <.0001).


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“The BEACON study showed that the combination of Erbitux and encorafenib significantly improved overall survival in patients with metastatic colorectal cancer with a BRAF V600E mutation – a subtype that typically has worse outcomes compared to those without the mutation,” said David Hyman, MD, chief medical officer, oncology at Lilly.

In April 2020, the FDA approved Braftovi for this indication based on data from the phase 3 BEACON CRC trial.

References

  1. FDA expands Lilly’s Erbitux® (cetuximab) label with combination of Braftovi® (encorafenib) for the treatment of BRAF V600E mutation-positive metastatic colorectal cancer (CRC) after prior therapy. News release. Eli Lilly and Company. Accessed September 29, 2021. https://www.prnewswire.com/news-releases/fda-expands-lillys-erbitux-cetuximab-label-with-combination-of-braftovi-encorafenib-for-the-treatment-of-braf-v600e-mutation-positive-metastatic-colorectal-cancer-crc-after-prior-therapy-301387268.html
  2. Erbitux. Package insert. Eli Lilly and Company; 2021. Accessed September 29, 2021. http://pi.lilly.com/us/erbitux-uspi.pdf.

This article originally appeared on MPR