Key Points –
- SMC approved Combination of Opdivo (Nivolumab) plus Cabometryx (Cabozantinib) for treatment of Advanced Renal Carcinoma
- In a Phase III study, the risk of death for advanced RCC patients was decreased by 34% with the Cabometryx plus Opdivo combination compared to currently availably therapy Sunitinib
The Scottish Medicines Consortium (SMC) has backed Opdivo (Nivolumab) plus Cabometryx (Cabozantinib) as a first-line therapy for people with advanced renal cell carcinoma (RCC), a common form of kidney cancer.
The move comes after a review of the regimen by NICE for England and Wales was suspended in April, with no agreement on an access deal. A committee meeting scheduled to review the combination in July was cancelled, although NICE says discussions are continuing.
Ipsen said in a statement that around 230 of the 1,000 or more Scottish patients diagnosed with RCC each year could be eligible for the treatment combination.
The combination of Opdivo with Cabometryx – an oral tyrosine kinase inhibitor which inhibits blood vessel formation in tumors – was approved by the EMA in March.
In a Phase III study, the risk of death for advanced RCC patients was decreased by 34% with the Cabometryx plus Opdivo combination compared to currently availably therapy Sunitinib.
The study also hit its primary endpoint of progression-free survival (PFS), with median PFS doubling from 8.3 months on Sunitinib to 17.0 months when compared to Cabometryx plus Opdivo.
“Today’s news is a clear demonstration of Scotland being at the forefront of cancer care, with local patients the first to benefit from this treatment approach. With incidence of RCC rising in Scotland over the last decade, this recommendation will mark an important milestone for patients with advanced disease,” said Robert Jones, professor of Clinical Cancer Research, University of Glasgow.
The green light came on the back of phase 3 results which showed that it reduced the risk of death (34%) by a third compared to Pfizer’s Sutent (Sunitinib), a standard first-line treatment which is also available as a generic.
The recommended dose is Nivolumab 240 mg every 2 weeks (30-minute intravenous infusion) or 480 mg every 4 weeks (30-minute intravenous infusion) in combination with Cabozantinib 40 mg orally once daily without food until disease progression or unacceptable toxicity.
The time before disease progression or death was also extended with the two-drug regimen to 17 months from 8.3 months with Sunitinib.
Cabometryx + Opdivo Targeted Therapy
PATIENTS LIVED 2X LONGER WITHOUT CANCER PROGRESSING
Spreading, growing, or getting worse.
Half of patients on OPDIVO + CABOMETYX went 16.6 months without cancer growing, spreading, or getting worse.
Half of patients on SUTENT went 8.3 months without cancer growing, spreading, or getting worse.
OPDIVO + CABOMETYX reduced the risk of cancer spreading, growing, or getting worse by 49% compared to SUTENT alone.
IN A CLINICAL TRIAL OF 651 KIDNEY CANCER PATIENTS
- 323 patients were given OPDIVO + CABOMETYX® (CABOZANTINIB)
- 328 patients were given SUTENT® (Sunitinib malate), a standard treatment
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