The combination of Merck’s Keytruda and Eisai’s Lenvima has recently received the designation of Breakthrough Therapy by U.S. Food and Drug Administration, for the treatment of advanced Endometrial Carcinoma. The investigational combination is specifically important for those patients who have advanced or metastatic MSI-H (non-microsatellite instability high) or pMMR (proficient mismatch repair) endometrial cancer. These patients experience worsening of their disease after one systemic therapy at least.
Breakthrough Therapy Designation is assigned to those therapies or medical technology that proffers quiet significant alternatives for otherwise existing options. This designation speeds up the approval for those medications meant for life-threatening diseases.
The decision came from the finding of the Study 111 phase 1b/2 in which endometrial cancer patients took part. It tested and analyzed the effectiveness of Lenvima-Keytruda combo and its safety for adults with specific solid tumors. This study also included cases of renal cell carcinoma, urothelial cancer, melanoma, non-small cell lung cancer and squamous cell neck and head cancer. A daily dose of 20mg of Lenvima was given orally to the patients and 200mg of Keytruda was injected into the patient after every 3 weeks.
In phase1b, the most tolerable dose of this combination was found out and tested. In phase 2, treatment’s ORR (objective response rate) was analyzed. Here it means, the percentage of patients gone through a reduction in the size of predefined tumors over a minimum course of time (24 weeks). Another, objective of phase 2 was to determine the rate of progression-free survival (PFS). PFS is the time period during the treatment or after it with no cancer progression.
The findings after 24 weeks showed a reduction in tumor size for 39% of patients, with 3 of these patients showing a full-fledged response. The response duration ranged from six months or more for 83% of the patients whereas 64.5% showed 12 months or more response duration. The median duration was found to be 7.4 months.
A phase 3 of the trial is ongoing in which the combination is going to be tested for recurrent endometrial cancer. Roy Baynes, a senior vice president from Merck Research Laboratories, says that his company will look to work closely with Eisai to produce the Lenvima-Keytruda combo for the benefit of these patients.
The combo was further given the Breakthrough Therapy designation for renal cell carcinoma patients.