Keytruda-Lenvima Combo Fails to Top Lenvima Alone in Patients With Unresectable Liver Cancer

Treatment with Keytruda plus Lenvima did not best Lenvima alone as a first-line treatment option for a group of patients with liver cancer that could not be treated with surgery, according to recently announced study results from a phase 3 clinical trial.

The use of Keytruda (pembrolizumab) plus Lenvima (lenvatinib) failed to improve both overall survival and progression-free survival compared with single-agent Lenvima in patients with unresectable hepatocellular carcinoma, a type of liver cancer that cannot be treated with surgery.

Merck and Eisai — the manufacturers of Keytruda and Lenvima, respectively — recently announced that although findings from the phase 3 LEAP-002 trial showed that there was a trend toward improvements in overall survival (the time from date of diagnosis or start of treatment until death from any cause) and progression-free survival (time during and after cancer treatment a patient survives without disease progression), the findings were not statistically significant.

When data are considered statistically significant, it means that the investigators are confident that the results are in fact due to whatever they were studying. In this case, there was a lack of confidence that Keytruda combined with Lenvima bested Lenvima alone in improving outcomes.

“Our joint clinical development program for Keytruda plus Lenvima is designed to address unmet needs for some of the most challenging-to-treat types of cancer, like hepatocellular carcinoma,” Dr. Gregory Lubiniecki, vice president of global clinical development at Merck Research Laboratories, said in a press release. “We remain confident in the potential of this combination based on the body of evidence we’ve seen to date and will continue to investigate its role across multiple types of cancer.”

In the phase 3 LEAP-002 trial, approximately 794 patients were randomly assigned to receive Lenvima plus Keytruda or Lenvima plus placebo. The investigators hypothesized that the results of the trial would show that the combination was superior to Lenvima alone.

“Aiming for further improvement in the treatment of patients with unresectable hepatocellular carcinoma, we selected Lenvima monotherapy, a standard of care option, as the control arm of the LEAP-002 trial,” Dr. Corina Dutcus, senior vice president of clinical research in oncology at Eisai Inc., said in the release. “While results evaluating the combination are not what we had hoped for, we will continue to contribute to the care of patients with unresectable hepatocellular carcinoma by applying valuable knowledge from the LEAP-002 trial.”

In 2018, the Food and Drug Administration (FDA) approved single-agent Lenvima for the treatment of patients with unresectable hepatocellular carcinoma. In the years since, the FDA has greenlit the combination of Keytruda and Lenvima for the treatment of several cancer types, including endometrial cancer and kidney cancer.

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