Taiho Oncology and Taiho Pharmaceutical have announced U.S. Food and Drug Administration (FDA) approval of Lonsurf alone or in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have undergone two prior regimens of treatment. 

In clinical trials, the approved therapy showed improvements in overall survival and progression-free survival among mCRC patients who experienced disease progression or intolerance during previous chemotherapy regimens, as compared to Lonsurf alone.

The approval applies to patients with the following treatment histories:

• Previously treated with fluoropyrimidine-based chemotherapy
• Previously treated with oxaliplatin-based chemotherapy
• Previously treated with irinotecan-based chemotherapy
• Previously treated with an anti-VEGF biological therapy 
• If the patient has a RAS wild-type mutation, previously treated with an anti-EGFR therapy

“The FDA approval of this combination provides patients with mCRC an important new treatment option, one that has been shown to extend life in addition to other benefits and which I believe will change the treatment landscape for this patient population,” said Marwan Fakih, MD, a professor at City of Hope and the lead U.S. investigator for the pivotal Phase 3 SUNLIGHT trial that evaluated this combination. “Notably, the use of Lonsurf plus bevacizumab in these patients did not result in an increase in potentially intolerable side effects that might limit the utility of this combination.”

The SUNLIGHT trial was the first large-scale (phase 3) study to compare a new treatment against an existing treatment in patients who had already undergone two previous chemotherapy regimens. The results showed a meaningful improvement in effectiveness and a good safety profile, including:

• A 39% reduction in the risk of death in patients with mCRC who were treated with Lonsurf in combination with bevacizumab
• A 56% relative risk reduction of disease progression in patients with mCRC who were treated with Lonsurf in combination with bevacizumab
• Consistent results regardless of a patient’s age, sex, location of primary disease, number of metastatic sites, KRAS mutation status, and prior bevacizumab treatment
• The most frequent severe side effects for Lonsurf plus bevacizumab versus Lonsurf alone were neutropenia, which is an abnormally low number of a type of white blood cell, (43.1% vs 32.1%) and anemia (6.1% vs 11.0%), respectively

“From Taiho Pharmaceutical’s initial discovery of Lonsurf to this latest regulatory milestone, we are appreciative of the investigators and patients who helped to contribute to our growing body of knowledge of this important therapeutic through their participation in our clinical development programs,” said Fabio Benedetti, MD, Global Chief Medical Officer for Oncology, Taiho Pharmaceutical Co., Ltd. “And now we look forward to supporting healthcare professionals in the treatment of patients with mCRC who may be candidates for treatment with LONSURF in combination with bevacizumab.”

Read Taiho Oncology’s full press release here.