New survival data for Merck, Eisai’s Keytruda/Lenvima combination shows promise in kidney cancer

New data for Merck & Co (MSD) and Eisai’s Keytruda plus Lenvima combination treatment has demonstrated further promise for the therapy in advanced renal cell carcinoma (RCC) – the most common form of kidney cancer in adults.

The new investigational data, revealed at the virtual American Society of Clinical Oncology’s Genitourinary Cancers Symposium (ASCO GU), comes from the phase 3 KEYNOTE-581/CLEAR study.

In this study, checkpoint inhibitor Keytruda (pembrolizumab) plus Lenvima (lenvatinib) and Lenvima plus everolimus were compared to Pfizer’s tyrosine kinase inhibitor (TKI) Sutent (sunitinib) for the first-line treatment of patients with advanced RCC.

In the oral presentation session at ASCO GU, Merck and Eisai revealed that the Keytruda plus Lenvima combo demonstrated statistically significant improvements for both progression-free survival (PFS) and overall survival (OS).

Keytruda plus Lenvima led to a 61% reduction in the risk of disease progression or death and also reduced the risk of death by 34%.

The median PFS for patients in the Keytruda plus Lenvima group was 23.9 months, compared to 9.2 months for patients who received Sutent.

Median OS had not yet been reached in either treatment arm after an average follow-up of 27 months.

The overall response rate (ORR) for Keytruda plus Lenvima-treated patients was 71% compared to 36.1% in the Sutent group.

On measures of complete response (CR) rate and partial response (PR) rate, Keytruda plus Lenvima posted 16.1% and 54.9% compared to Sutent’s 4.2% and 31.9%, respectively.

In addition to the positive results for the Keytruda plus Lenvima combo, Merck and Eisai added that Lenvima plus everolimus also showed improvements in PFS and ORR compared to Sutent.

This included a reduction in the risk of disease progression or death by 35% for Lenvima plus everolimus and a median PFS of 14.7 months compared to 9.2 months for patients receiving Sutent.

However, Lenvima plus everolimus did not demonstrate an improvement in OS compared with Pfizer’s drug.

“These promising results are a testament to our company’s commitment to help improve outcomes for patients diagnosed with cancer,” said Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories.

“In this trial, Keytruda plus Lenvima demonstrated superior efficacy benefits compared with Sutent. If approved, we believe this combination has the potential to be an important new treatment option for patients with advanced renal cell carcinoma in the first-line setting,” he added.

Bristol Myers Squibb (BMS) and Exelixis also recently revealed new analyses from a phase 3 study of their Opdivo (nivolumab) and Cabometyx (cabozantinib) combination in first-line, advanced RCC.

After a median follow-up of two years, the Opdivo/Cabometyx combination continued to demonstrate superior progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) compared to Sutent.

BMS/Exelixis’ combination treatment doubled median PFS compared to Sutent, and also demonstrated a 34% reduction in the risk of death compared to Pfizer’s drug.

Opdivo/Cabometyx was also associated with a disease control rate of 88.2% versus 69.9% with Sutent.