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Merck Keytruda is the king of tumor immunotherapy, with sales in the first three quarters of this year reaching 12.
In March 2018, Merck and Eisai signed a cooperation agreement totaling US$5.
However, in terms of lung cancer, the combination has recently suffered a major setback
According to the researchers, from the interim observation results of the Phase 3 LEAP-007 trial, Keytruda monotherapy is still the standard care plan for this patient group
The results of the LEAP-007 trial showed that the median overall survival (OS) of the patient group receiving Keytruda+Lenvima first-line treatment was 14.
In addition, no survival benefit was observed in all patient subgroups
Compared with Keytruda monotherapy, the combination of Keytruda+Lenvima did reduce the overall risk of tumor progression or death by 22%, but this did not translate into prolonged survival
Roy Baynes, chief medical officer of Merck Research Laboratories, said in an interview that compared with Keytruda+ chemotherapy, Keytruda monotherapy is usually used for patients with comorbidities
Although the first-line treatment of NSCLC failed, the combination therapy of Keytruda and Lenvima has been approved by the US FDA for several indications, including the approval of the first-line treatment of renal cell carcinoma (RCC) in August
The LEAP-006 trial, which has been fully enrolled, is testing whether the addition of Lenvima to the Keytruda+ chemotherapy regimen can bring additional benefits to the first-line treatment of non-squamous NSCLC patients
More importantly, no matter the new combination may eventually show any additional efficacy, it needs to be powerful enough to be worthy of the additional toxicity brought by Lenvima
At least in the LEAP-007 trial, the combination of Keytruda+Lenvima without chemotherapy did not show any additional survival benefits for the non-squamous subgroup, and compared with Keytruda alone, the hazard ratio (HR) was 0.
In addition, the Phase 3 LEAP-008 trial is still enrolling patients.
A Merck spokesperson confirmed to FiercePharma that the LEAP-006 and LEAP-008 trials are still in progress, and the end date is August 2023
Reference source: Merck, Eisai's 007 goes down as Keytruda-Lenvima combo fails in newly diagnosed lung cancer
