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ASCO-GU preview: showdown for Exelixis

Among the abstract titles from ASCO’s upcoming Genitourinary Cancers Symposium, all of which are now available, one that stands out concerns the Contact-02 trial of Exelixis/Ipsen’s Cabometyx in second-line prostate cancer. That study was toplined as positive for progression-free survival last August, marking a rare success for the Cabometyx franchise beyond its blockbuster kidney cancer setting. Truist analysts say seeking approval in prostate cancer is a top 2024 priority for Exelixis, though the FDA is seeking a “mature survival signal” – something that might prove tricky given Contact-02’s design. ASCO-GU takes place in San Francisco on 25-27 January, coming swiftly after ASCO-GI, which itself follows this week’s JP Morgan healthcare conference. A separate ASCO-GU abstract features Harpoon’s anti-DLL3 T-cell engager HPN328, and could provide backing for Merck & Co’s $680m acquisition of this company. Meanwhile, notable late-breakers include the Checkmate-67T trial that could back first approval of a subcutaneous formulation of Opdivo, and overall survival data from the Keynote-564 study whose disease-free survival benefit backs Keytruda’s approved use in adjuvant kidney cancer.

 

Selected ASCO-GU presentations

TrialCompanyProject/settingAbstractNote
Checkmate-67TBristol Myers SquibbOpdivo SC vs Opdivo IVLBA360Toplined positive for non-inferiority, Oct 2023
Checkmate-914Bristol Myers SquibbOpdivo +/- Yervoy in adjuvant kidney cancerLBA358Part B (Opdivo monotherapy) results; part A (combo) failed on DFS vs placebo, Sep 2022
Contact-02Exelixis/IpsenCabometyx + Tecentriq in 2nd-line (post NHT*) mCRPC18Toplined positive for PFS vs 2nd NHT*, Aug 2023
NCT04471727HarpoonHPN328 in neuroendocrine prostate cancer121Had data at ESMO 2023; company sold to Merck & Co
Keynote-564Merck & CoKeytruda in adj renal cell carcinomaLBA359OS data (approved on DFS)
Keynote-123Merck & CoKeytruda in adjuvant MIBCLBA531Toplined positive for DFS vs observation, Oct 2023
AnticipateAsieris PharmaceuticalAPL-1202 (MetAP2 inhibitor) + tislelizumab in neoadjuvant MIBC632Toplined positive for pCR vs tislelizumab, Sep 2023

Note: *NHT=novel hormonal therapy, ie, Xtandi, Zytiga or similar. Source: ASCO.