Merck & Co/Eisai eye kidney cancer use for immunotherapy combination

Merck & Co and Eisai are to file results from a phase 3 trial testing a combination of the former’s immunotherapy Keytruda, combined with the latter’s cancer drug Lenvima in untreated patients.

Keytruda (pembrolizumab) and Lenvima (lenvatinib) outperformed standard care – Pfizer’s Sutent (sunitinib) – in untreated patients with advanced renal cell carcinoma when measured against progression-free survival (PFS) and secondary goals of overall survival (OS) and overall response rate (ORR).

The companies said the results in the intention to treat population would be shared with regulators across the world.

Merck & Co, known as MSD outside North America, gave no further details about the results but said that the improvements were “statistically significant and clinically meaningful” in the group that included across all risk group categories – favourable, intermediate and poor.

Results came from the 1,050 patient KEYNOTE-581/CLEAR trial, also known as Study 307, testing Lenvima in combination with Keytruda or in combination with everolimus, with patients taking Pfizer’s Sutent in the control group.

Patients were randomly assigned to three groups, either receiving Lenvima (18mg orally once daily) in combination with everolimus (5mg orally daily), Lenvima (20mg orally once daily) plus Keytuda (200mg intravenously every three weeks), or Sutent daily once daily for four weeks on treatment followed by two weeks off treatment.

The primary endpoint is PFS by independent review per RECIST v1.1 criteria.

Further details will be revealed at an upcoming medical meeting.

Keytruda was approved in combination with Pfizer's Inlyta (axitinib) in first line kidney cancer last year, which is competing against the combination of BMS’ rival PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab).

Merck KGaA/Pfizer’s Bavencio (avelumab), was approved for first-line RCC in combination with Inlyta in May last year.

US-based Merck and Eisai are continuing to study the Keytruda plus Lenvima combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).