How long does Lonsurf increase survival in colorectal cancer?

Key Points

In studies, Lonsurf has been shown to extend survival in patients with colorectal cancer that has spread (metastatic cancer) when used either as a single drug (median survival of 7.1 months) or when combined with bevacizumab (median survival of 10.8 months).

Study 1. Lonsurf compared to placebo

• In colorectal cancer clinical studies looking at Lonsurf used alone, half of patients treated with Lonsurf tablets were alive at 7.1 months compared to 5.3 months for half of those treated with placebo (a sugar pill), a statistically significant result.
• Survival in patients in the Lonsurf group ranged from 6.5 months to 7.8 months, while the placebo group survival ranged from 4.6 to 6 months.
• On average, the time to cancer progression was 2 months for patients on Lonsurf compared to 1.7 months for patients receiving a placebo. Worsening of the disease or death occurred in 88% of patients treated with Lonsurf and 94% of patients who received placebo.

Study 2: Lonsurf + bevacizumab compared to Lonsurf alone

• In the Phase 3 SUNLIGHT trial, when Lonsurf was given in combination with bevacizumab (brand example: Avastin), half of the patients with metastatic colorectal cancer were alive at 10.8 months compared to 7.5 months in the Lonsurf group alone, a 39% reduction in the risk of death.
• Progression-free survival (PFS) is the length of time during and after treatment that a patient lives with the cancer but it does not get worse. In this study, half of the patients who received Lonsurf plus bevacizumab had a PFS of 5.6 months compared to 2.4 months in the group that received Lonsurf only. This yielded a 56% relative risk reduction of disease progression.

What is Lonsurf?

• Lonsurf (trifluridine and tipiracil) was approved in 2015 for patients with advanced (metastatic) colorectal cancer who are no longer responding to other therapies, such as certain chemotherapy and biological therapy.
• Lonsurf was also approved for previously treated metastatic gastric (stomach) cancer in 2019.
• In August 2023, Lonsurf in combination with bevacizumab was approved to treat adults with metastatic colorectal cancer (mCRC) previously treated with other therapies but are no longer responding.

Lonsurf is classified as a nucleoside metabolic inhibitor which is incorporated directly into DNA and interferes with its function. The blood level of trifluridine is maintained by the enzyme inhibitor tipiracil.

Lonsurf is manufactured by Taiho Oncology.

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What are the most common side effects with Lonsurf?

Common side effects reported with Lonsurf include:

• tiredness and lack of energy (fatigue, weakness)
• nausea and vomiting
• decreased appetite
• diarrhea
• abdominal (stomach) pain
• fever

Lonsurf can also cause common and serious side effects such as anemia (low red blood cells), neutropenia (low white blood cells), and thrombocytopenia (low blood platelets). Low white blood cells can make you more likely to have a serious infection that may lead to death. Your doctor will periodically check your blood cell counts.

It is not known if Lonsurf is safe or effective in children. Tell your doctor if you are pregnant or plan to become pregnant because Lonsurf can harm your unborn baby. Females should use effective birth control during and for 6 months after the last dose of treatment with Lonsurf.

This is not all the information you need to know about Lonsurf (trifluridine and tipiracil) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Lonsurf information here, and discuss this information and any questions you have with your doctor or other health care provider.