Akeso’s HARMONi-6 overall survival data for ivonescimab hits ASCO’s plenary session Sunday, May 31 — and the compliance question behind every seat in that room is simpler than it looks: how much of Keytruda’s multi-billion-dollar NSCLC franchise is actually at risk?
The Phase 3 trial pits ivonescimab plus chemotherapy against tislelizumab (BeOne’s Tevimbra) plus chemotherapy in first-line squamous NSCLC. Progression-free survival already came in at 11.14 months versus 6.9 months for the comparator. BMO Capital Markets, in a Friday note, called its bull-case hazard ratio at 0.65–0.72. A hazard ratio that low, on overall survival, in a head-to-head against an anti-PD-1 agent, is the kind of signal that resets commercial models.
Summit has already filed an FDA application for ivonescimab in a later line of NSCLC treatment. A strong HARMONi-6 OS readout would push the regulatory argument toward first-line, a population segment worth more.
The money tells the story: AbbVie paid RemeGen $650 million upfront in January, with up to $4.95 billion in milestones, for its own PD-1/VEGF bispecific, RC148. BioNTech and BMS structured a deal worth up to $11 billion for pumitamig, whose Phase 2/3 ROSETTA Lung-02 data also appears at ASCO Saturday. These aren’t speculative bets — they’re competitive hedges against whichever asset wins this race.
Merck’s position is the read-across worth watching. The company deprioritized its own PD-1/VEGF candidate, MK-2010, and put its chips on the TROP2-directed ADC sacituzumab tirumotecan, licensed from Kelun-Biotech for up to $9.3 billion. BMO asked the question directly: “Did Merck prioritize the right asset in looking for what’s next in solid tumor oncology?” It’ll have more data to answer that by end of weekend. Keytruda loses patent exclusivity in 2029, which means any successor asset needs to demonstrate meaningfully differentiated efficacy before a generic version undercuts the market on price.
Worth reading the HARMONi-6 abstract before Monday’s open.
Rebecca Lauren