Opdivo-Cabometyx combo improves PFS by 49%, OS by 40% in first-line RCC

Exelixis jumped $4.14 (21%) to $23.58 on Monday, pushing its valuation above $7 billion, after the biotech and partners Bristol Myers Squibb and Ipsen said the combination of Opdivo nivolumab plus Cabometyx cabozantinib generated positive Phase III data that could challenge a similar combination of Keytruda pembrolizumab and Inlyta axitinib in first-line advanced renal cell carcinoma patients.

The Phase III CheckMate -9ER trial of PD-1 inhibitor Opdivo plus kinase inhibitor Cabometyx met the primary endpoint of significantly extending progression-free survival (PFS) vs. Sutent sunitinib in patients with untreated advanced RCC, leading to a 49% reduction in the risk of progression or death (HR=0.51, p<0.0001). That is comparatively better than the interim readout that led to the approval of the competing Keytruda-Inlyta combo, which in the Phase III KEYNOTE-426 trial in the same patient setting had a 31% risk reduction on PFS vs. Sutent (see “Keytruda, Inlyta Combo Improves OS by 47%, PFS by 31% in First-Line RCC”)...