Levnima and Keytruda combination
Merck & Company (MRK) and Eisai are conducting the Phase 3 KEYNOTE-146 trial to evaluate the safety and efficacy of Levnima and Keytruda as a combination therapy for the treatment of individuals with unresectable solid tumors (non-small cell lung cancer, endometrial cancer, renal cell carcinoma, melanoma, squamous cell carcinoma of the head and neck, and urothelial cancer) whose disease has progressed after treatment with approved therapies.
In the KEYNOTE-146 trial, a Levnima and Keytruda combination therapy demonstrated evidence of synergistic effects on the overall response rate of individuals with select solid tumors (renal cell carcinoma and endometrial cancer) irrespective of prior treatment or PD-L1 tumor expression.
KEYNOTE-146 trial and other ongoing trials
As per an investigator review of the renal cell carcinoma cohort 1 of the KEYNOTE-146 trial, after 24 weeks, a Keytruda and Levnima combination demonstrated an overall response rate of 63%, and tumor regression was observed in 93% of patients from the time of the treatment’s initiation.
In the endometrial cancer cohort of the KEYNOTE-146 trial, a Keytruda and Lenvima combination therapy demonstrated an overall response rate of 52.2% at week 24, according to an independent radiologic review. Some important drugs in use for the treatment of renal cell carcinoma include Exelixis’s (EXEL) Cabometyx, Pfizer’s (PFE) Inlyta, and Novartis’s (NVS) Votrient.
Eisai and Merck are conducting various clinical trials for the label expansion of Lenvima. Presently, a Phase 3 trial is being conducted with Lenvima in China to evaluate its safety and efficacy in the treatment of thyroid cancer. Phase 2 trials are in progress with Lenvima for the evaluation of its safety and efficacy in the treatment of biliary tract cancer and non-small cell lung cancer.
Eisai and Merck are conducting a Phase 1b trial with a Lenvima and Keytruda combination therapy for the treatment of individuals with select solid tumors. A Phase 1b trial is also in progress for the evaluation of a Lenvima and nivolumab combination therapy for the treatment of hepatocellular carcinoma.
These extensive clinical trials and their potential successes will aid in the label expansion of Lenvima. The superior data from the clinical trials are expected to strengthen the drug’s commercialization capabilities.