Samsung Bioepis will continue to present its biosimilar pipeline at ASCO this year by unveiling the three-year follow-up subgroup analysis of SB3 (Original: Herceptin), also known as Ontruzant, and reference trastuzumab in patients with HER2-positive early breast cancer.

The company monitored the quality characteristics of Herceptin and found that antibody-dependent cell-mediated cytotoxicity activities (ADCC) were significantly lowered in the original lot from the end of the period from August 2018 to December 2019.

Within the Herceptin group, the research labeled patients exposed to at least one shifted ADCC lot as “exposed” and those never exposed to shifted ADCC lot during the neoadjuvant period as “unexposed.”

Later, the company conducted a follow-up analysis of event-free survival (EFS) and overall survival rate according to the ADCC status for three years.

At a median follow-up duration of 40.8 months in SB3 and 40.5 months in Herceptin, three-year EFS rates were 92.5 percent in SB3, 94.5 percent in Herceptin-unexposed group, and 82.5 percent in Herceptin-exposed and OS rates were 97, 100, and 90.6 percent, respectively.

“Within the Herceptin group, the exposed group showed significantly lower EFS compared to the unexposed group, while a similar trend was observed in OS with no statistical significance.” the company concluded. “Between SB3 and Unexposed, no significant difference in EFS or OS was observed.”

The company’s poster session at ASCO comes at a sensitive time for the company.

In the U.S., the FDA has approved Ontruzant across all eligible indications. The treatment treats HER2-overexpressing breast cancer, metastatic breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma in patients who have not received prior therapy for metastatic disease.

Ontruzant is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.

In Korea, however, the company is going through a rough patch as the company is still embroiled in an accounting fraud allegation investigation, which is gaining traction.

In April, the Seoul Central District Prosecutors Office sought an arrest warrant of two executives of Samsung Bioepis for allegedly destroying evidence linked to Samsung BioLogics’s accounting fraud allegations. Lately, prosecutors sought another arrest warrant for an employee working at Samsung Bioepis’ security division for allegedly carrying out activities to destroy such evidence.

SB3 treats early breast cancer, metastatic breast cancer, and metastatic gastric cancer. Its original, Herceptin, is one of the world’s most purchased medicines with an annual sale of $6.9 billion in 2015.

The company plans to present its poster session on June 2, at Hall A of the McCormick Place in Chicago, Ill.

corea022@docdocdoc.co.kr

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