Servier, Taiho Oncology Prep to Submit Cancer Drug Combo to FDA

Courtesy of Getty Images

Courtesy of Getty Images

Servier and Taiho Oncology announced Tuesday that Lonsurf in combination with bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer.

Courtesy of Getty Images

A combination of Lonsurf (trifluridine/tipiracil) and bevacizumab improved overall survival rates in patients with refractory metastatic colorectal cancer (mCRC), Servier and Taiho Oncology announced Tuesday.

The companies released data from the trial ahead of an oral presentation scheduled for Jan. 21st at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco.

Researchers evaluated the combinatorial cancer therapeutic in a multinational Phase III clinical trial dubbed “SUNLIGHT.” The trial aimed to compare the efficacy of Lonsurf plus bevacizumab to that of Lonsurf by itself in patients with refractory mCRC.

Data analysis showed that patients treated with the investigational combination demonstrated a statistically significant and clinically meaningful improvement in an overall survival rate of 3.3 months compared to those treated with the monotherapy. The improvement in overall survival translated to a 39% death risk reduction.

Additionally, the data demonstrated that patients treated with Lonsurf plus bevacizumab achieved statistically significant improvement in progression-free survival of 3.2 months.

The combination therapy and monotherapy patient groups experienced similar rates of severe adverse events. The most frequently reported adverse events included neutropenia and anemia.

Taiho and Servier are prepared to submit these findings to the FDA for review.

Separately, Lonsurf and bevacizumab have been approved to treat mCRC by the FDA.

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