DTMT Network

US-based pharmaceutical giant Merck has announced that its anti-PD-1 therapy Keytruda has failed to meet the primary endpoint of improving the overall survival rate and progression-free survival as the first line of therapy when given in combination with Eisai’s multiple receptor tyrosine kinase inhibitor, Lenvatini, marketed under the brand Lenvima, compared to Lenvatini monotherapy to treat patients of liver cancer who cannot be operated upon, in phase 3 Leap-002 trial.

Though some trends indicated improvement among the patients receiving the combination therapy, the difference was not statistically significant, the company said in a statement on August 3, 2022.

“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, Merck’s Vice President for Global Clinical Development said.

“We remain confident in the potential of this combination based on the body of evidence we have seen to date and will continue to investigate its role across multiple types of cancer,” he added.

Stating that the results of the trial are contrary to what they had hoped for, Eisai’s Senior Vice President in charge of clinical research, Dr Corina Dutcus said, “We will continue to contribute to the care of patients with unresectable HCC (inoperable liver cancer)  by applying valuable knowledge from the LEAP-002 trial.”

It may be recalled that the United States Food and Drug Administration (FDA) rejected the duo’s application for approval in 2020, as the early response data did not provide evidence that the combination provided a meaningful advantage over available therapies for the treatment of unresectable or metastatic [hepatocellular carcinoma] with no prior systemic therapy for advanced disease.

Meanwhile, in a  separate statement, the company informed that Keytruda has failed to meet the primary endpoint of the  Keynote-921 trial in improving the overall survival or radiographic progression-free survival for the treatment of patients with metastatic castration-resistant prostate cancer, an advanced form of prostate cancer where cancer fails to respond even after  body’s testosterone levels are lowered.

“Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate Keytruda-based combinations and novel candidates for patients with this disease,” Dr Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories said.