#ESMO22: Relay Therapeutics joins the winner's circle this weekend as updated cancer data win applause

08 Sep 2022
endpts.com
Accelerated ApprovalIPO
PARIS — Relay Therapeutics had steadily raised the bar ahead of ESMO for RLY-4008, its bile duct cancer drug for a narrow group of patients with FGFR2-altered cholangiocarcinomaFGFR2-altered cholangiocarcinoma. And now it’s arriving in Paris with an improved performance that appears to pave a direct path to a quick approval.
The bottom line from its ESMO abstract:
Potent efficacy was observed across all doses, particularly at the RP2D (70mg QD) with an ORR of 88%. One pt treated at the RP2D had a near-complete response and subsequent tumor resection with curative intent. DOR is not yet mature, with majority of responses ongoing. Across all doses (N=195), the most common treatment-related AEs (TRAEs) were low-grade stomatitis (48%), PPE (46%), and dry mouth (31%). No grade 4/5 TRAEs were observed.
Relay builds out case for anti-FGFR drug, shooting for first accelerated approval on 'motion-based' drug discovery platform
That’s more than double the rate of response tracked for the pan-FGFR inhibitors now in use, notes Stifel’s Bradley Canino:
The cORR of 82% is an increase from the previous data cut in June 2022, where 62% (8 of 13) FGFRi-naïve dose-escalation patients responded across all daily doses (20-70mg QD). In that cut, which was diluted by lower, less potent doses, there were 4 patients on 70mg, and all (100%) achieved a cPR. Competitively, The RLY-4008 efficacy is double or higher than the pan-FGFR inhibitor results of ~30-40% ORRs. The RLY-4008 profile strongly supports an accelerated approval opportunity in FGFRi-naïve FGFR2 fusion+ CCA, which will be supported by the ongoing n=100 expansion cohort from which several of the patients reported in the abstract are included.
Cowen’s Yaron Werber sums it up this way:
These data are solid, validate the platform, and are clearly differentiated.
Relay went public $RLAY under CEO Sanjiv Patel after a celebratory $400 million round two years ago. And the IPO — highlighting its motion-based discovery platform — hit big at a time of general euphoria for all things biotech. Its share price has dropped 22% over the past year, but that’s a major improvement over the average debacle in this market, and it’s been trending green now with more upbeat data to take to the FDA.
At the time it went public, Relay still played its R&D cards fairly close to its vest. But the confirmatory results researchers are rolling out this weekend leave them in a high-profile position, poised to take advantage of an FDA pathway that opens doors for drugs like this.
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