Late-Breaking Data Demonstrate Improved Progression-Free Survival in Patients with Metastatic Colorectal Cancer After Treatment with Boston Scientific TheraSphere™ Y-90 Glass Microspheres

Rhea-AI Summary

Boston Scientific announced positive results from the EPOCH clinical trial for TheraSphere Y-90 Glass Microspheres in treating metastatic colorectal cancer (mCRC) of the liver. The trial met both primary endpoints of progression-free survival (PFS) and hepatic progression-free survival (hPFS). With 428 patients involved, the trial showed that TheraSphere treatment significantly improved PFS and hPFS compared to standard chemotherapy alone. This data will support future FDA submissions, potentially providing broader access to this therapy for mCRC patients.

Positive

• EPOCH trial met primary endpoints of progression-free survival (PFS) and hepatic progression-free survival (hPFS).
• TheraSphere treatment significantly reduced disease progression by 31% and hepatic disease progression by 41% compared to chemotherapy alone.
• The trial's positive results may support a regulatory submission to the U.S. FDA for broader access to TheraSphere treatment.

Negative

• TheraSphere for mCRC currently remains investigational in the U.S., with safety and effectiveness not yet established.

MARLBOROUGH, Mass., Sept. 20, 2021 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced the EPOCH clinical trial of the TheraSphere™ Y-90 Glass Microspheres (TheraSphere treatment) successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) of patients with metastatic colorectal cancer (mCRC) of the liver. In the trial, TheraSphere treatment – a selective internal radiation therapy (SIRT) comprised of microscopic glass beads containing radioactive yttrium (Y-90) that are specifically delivered to target tumors – was used as a second-line treatment in combination with standard of care systemic chemotherapy (SOC) for patients who had disease progression during or after first-line chemotherapy. The clinical findings were presented today as late-breaking data at the European Society for Medical Oncology (ESMO) Congress 2021 and will be published in the Journal of Clinical Oncology.

"The EPOCH trial not only demonstrated positive safety and efficacy data for the patients treated in this study, but underscores the success of integrating a device-based therapy like TheraSphere treatment in the continuum of care with systemic chemotherapy and biologic regimens, thereby providing the rationale and setting the stage for future investigation in other cancer types," said Riad Salem, M.D., M.B.A, interventional radiologist at Northwestern Memorial Hospital and co-principal investigator of the EPOCH trial.ⁱ

An estimated 1.9 million global cases of colorectal cancer (CRC) are diagnosed each year, making it the third most common cancer worldwide.ⁱⁱ Approximately one third of all patients with CRC present with, or subsequently develop, metastases in the liver (liver dominant mCRC).ⁱⁱⁱ Patients with mCRC are most commonly treated with surgery and systemic chemotherapy, a therapy that targets the entire body. TheraSphere treatment, indicated for use in patients with hepatic neoplasia/malignancies including liver dominant mCRC in Canada, Europe and regions of Asia, delivers Y-90 directly to liver tumors via catheter, which minimizes radiation exposure to surrounding healthy tissue.

"EPOCH is the first positive phase 3 SIRT trial in any disease setting and the data is expected to support our regulatory submission to the U.S. FDA, with the hope that more patients with liver dominant mCRC will gain access to TheraSphere as a treatment option in the future," said Peter Pattison, president, Interventional Oncology, Peripheral Interventions, Boston Scientific.

The global, prospective EPOCH pivotal clinical trial is a phase 3 study, designed to assess therapeutic benefit compared to SOC, which randomized 428 patients with mCRC to second line chemotherapy, with or without the addition of TheraSphere treatment. Both primary endpoints were met and included progression-free survival and hepatic progression-free survival, which reflect how long patients live without the disease progressing further, both systemically and within the liver. The addition of TheraSphere treatment significantly increased both PFS (p=0.0013) and hPFS (p<0.0001). Patients receiving TheraSphere treatment with second-line chemotherapy were 31% less likely to show disease progression or death (HR = 0.69) and 41% less likely to show hepatic disease progression or death versus with chemotherapy alone (HR = 0.59).

"In the second line of therapy for metastatic colorectal cancer, with disease isolated to the liver, the addition of TheraSphere with chemotherapy resulted in a significant delay in overall tumor progression," said Mary F. Mulcahy, M.D., medical oncologist at Northwestern Memorial Hospital and co-principal investigator of the EPOCH trial.ⁱ "Additionally, chemotherapy-related adverse events were comparable between the trial arms."

Earlier this year, the U.S. FDA approved TheraSphere for the treatment of unresectable hepatocellular carcinoma (HCC) and granted Breakthrough Device Designation for expedited review as a treatment of patients with glioblastoma, an aggressive type of cancer that can occur in the brain or spinal cord. It is the only radioembolization technology in the U.S. indicated for unresectable HCC.

CAUTION: In the U.S., the use of TheraSphere for mCRC is for investigational use only as the safety and effectiveness have not been established.

For more information on TheraSphere treatment, visit www.therasphere.com.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit and connect on Twitter and Facebook.

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CONTACTS:

Karin Dalsin
Media Relations
(763) 494-1914 (office)
Karin.Dalsin@bsci.com

Lauren Tengler
Investor Relations
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BSXInvestorRelations@bsci.com

ⁱ Drs. Riad Salem and Mary F. Mulcahy are paid consultants for Boston Scientific Corporation. They have not been compensated for their quotes within this press release.
ⁱⁱ Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021;71(3):209-249. DOI:10.3322/caac.21660.
ⁱⁱⁱ Siebenhüner, A.R., Güller, U. & Warschkow, R. Population-based SEER analysis of survival in colorectal cancer patients with or without resection of lung and liver metastases. BMC Cancer 20, 246 (2020). https://doi.org/10.1186/s12885-020-6710-1

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SOURCE Boston Scientific Corporation

FAQ

What were the results of the EPOCH trial for BSX's TheraSphere treatment?

The EPOCH trial met its primary endpoints, showing significant improvements in progression-free survival (PFS) and hepatic progression-free survival (hPFS) for mCRC patients.

How does TheraSphere treatment improve outcomes for metastatic colorectal cancer patients?

TheraSphere treatment, when combined with chemotherapy, significantly reduced disease progression and hepatic disease progression compared to chemotherapy alone.

What is the significance of the EPOCH trial results for Boston Scientific (BSX)?

The positive results from the EPOCH trial may pave the way for a regulatory submission to the U.S. FDA, potentially increasing the availability of TheraSphere treatment for patients.

When was the EPOCH trial data presented for BSX?

The EPOCH trial data was presented at the European Society for Medical Oncology (ESMO) Congress on September 20, 2021.