Summit Therapeutics is gearing up for ivonescimab’s high-stakes FDA decision without its chief commercial officer (CCO) following a quiet shake-up of its launch division.
Beyond the CCO vacancy since August, Summit also eliminated other commercial and marketing leaders responsible for building the launch plan of ivonescimab, Fierce has learned.
After initially denying any layoffs and following multiple inquiries regarding the scope of the cuts, Summit eventually said, “we have not had any broad-based layoffs or reductions in force.”
“As with any organization, less than five employees have been separated from the commercial organization in recent months in the ordinary course of business,” the Summit Therapeutics media team added in an email.
Summit did confirm that Robert LaCaze, its former CCO hired in March 2025, is no longer with the company, leaving all commercial operations reporting to chief operating officer and chief financial officer, Manmeet Soni.
According to a person close to the company, Summit let go of “long-term players in commercial.” These spanned market access to commercial operations and were “the people who did the initial launch planning and moved those plans into maturity,” the person told Fierce.
The departures hit Summit just as the biotech approaches its first FDA decision for ivonescimab, its Akeso-partnered PD-1xVEGF bispecific, by Nov. 14. The company did not respond to Fierce’s question about the size of its commercial team and launch preparations.
During Summit's second-quarter earnings call in July, shortly before the departure of LaCaze and several commercial team members, Soni said the company was “extensively preparing” for ivonescimab's commercial launch.
“We have already hired all the leadership team with extensive experience with both biotechs and pharma who have multiple launch experiences,” Soni said. “We have market access team in place. We have marketing folks in place. Obviously, when you're talking about the field force, that generally comes a few weeks before the PDUFA date, but yes, we have all the planning and all the work under play.”
Whether the FDA will approve ivonescimab in Summit's application for previously-treated, EGFR-mutated non-small cell lung cancer remains highly uncertain.
Summit’s FDA application was risky after the global HARMONi trial missed its overall survival endpoint, as the agency explicitly requested a statistically significant OS to support a filing. Summit has blamed the failure on immature follow-up in the study's Western population.
According to a new June 2026 data cut-off, the OS hazard ratio in the Western subgroup of 165 patients improved to 0.76, compared to 0.84 at a September 2025 cut-off and 0.98 at the trial’s primary analysis in April 2025.
As questions swirl around ivonescimab's approvability, Summit's senior leadership proposed foregoing an internal launch meeting, which is commonly set up among biopharma companies to prepare their employees for market readiness, according to the person close to the company.
“What they're doing doesn't make sense for patients. It doesn't make sense for shareholders,” the anonymous source told Fierce. “It doesn't make sense for their own pocketbooks.”
In late September, AstraZeneca made a $2 billion bet in Summit Therapeutics to accelerate the development of ivonescimab in combination with the British pharma's antibody-drug conjugates (ADC).
The newly minted partners will start by testing ivonescimab—which is already approved in China for multiple non-small cell lung cancer indications—with AstraZeneca’s CLDN18.2-directed ADC in gastrointestinal cancers.