BMS and Exelixis’ Opdivo/Cabometyx shows continued benefit in kidney cancer

Bristol Myers Squibb (BMS) and Exelixis have revealed new analyses from a phase 3 study of their Opdivo and Cabometyx combination in kidney cancer.

The updated results come from the phase 3 CheckMate-9ER trial, which compared BMS’ checkpoint inhibitor Opdivo (nivolumab) and Exelixis’ tyrosine kinase inhibitor (TKI) Cabometyx to Pfizer’s older drug Sutent (sunitinib) in the first-line treatment of advanced renal cell carcinoma (RCC) – the most common type of kidney cancer in adults.

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.

In addition, an exploratory subgroup analysis of 75 patients with sarcomatoid features showed that the combination of Opdivo/Cabometyx had a benefit in this population, with a reduction in the risk of death of 64% compared to Sutent.

Opdivo/Cabometyx also demonstrated superior PFS (10.3 months versus 4.2 months) and ORR (55.9% versus 22%) in this patient population, compared to Sutent.

RCC with sarcomatoid differentiation is a highly aggressive form of the disease, and is typically associated with a particularly poor prognosis.

The US Food and Drug Administration (FDA) has already approved Opdivo/Cabometyx for the first-line treatment of advanced RCC.

BMS and Exelixis are also seeking approvals with additional health authorities globally, the companies added in a statement.

“This additional data from [the] CheckMate-9ER [trial] provides strong evidence that Opdivo in combination with Cabometyx may help patients achieve and maintain control of their disease,” said Dana Walker, vice president, development programme lead, genitourinary cancers, BMS.

“This regimen brings together two proven agents in advanced renal cell carcinoma, and we believe it will play an important role alongside other first-line treatment options,” she added.

Opdivo is already approved in combination with Yervoy (ipilimumab) as an initial treatment for advanced RCC patients, after the treatment showed an ability to improve survival compared to Sutent.

Both Opdivo combinations will compete with Merck & Co/MSD’s blockbuster checkpoint inhibitor Keytruda (pembrolizumab) plus Pfizer’s TKI Inlyta (ipilimumab), after the combination treatment received FDA approval in the same indication in 2019.

Topline results from the phase 3 Keynote-426 trial of Keytruda plus Inlyta in first-line RCC showed an overall response rate of 59.3%, alongside a 47% reduction in the risk of death compared to Sutent.