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
| Trial | Company | Project/setting | Abstract | Note |
|---|---|---|---|---|
| Checkmate-67T | Bristol Myers Squibb | Opdivo SC vs Opdivo IV | LBA360 | Toplined positive for non-inferiority, Oct 2023 |
| Checkmate-914 | Bristol Myers Squibb | Opdivo +/- Yervoy in adjuvant kidney cancer | LBA358 | Part B (Opdivo monotherapy) results; part A (combo) failed on DFS vs placebo, Sep 2022 |
| Contact-02 | Exelixis/Ipsen | Cabometyx + Tecentriq in 2nd-line (post NHT*) mCRPC | 18 | Toplined positive for PFS vs 2nd NHT*, Aug 2023 |
| NCT04471727 | Harpoon | HPN328 in neuroendocrine prostate cancer | 121 | Had data at ESMO 2023; company sold to Merck & Co |
| Keynote-564 | Merck & Co | Keytruda in adj renal cell carcinoma | LBA359 | OS data (approved on DFS) |
| Keynote-123 | Merck & Co | Keytruda in adjuvant MIBC | LBA531 | Toplined positive for DFS vs observation, Oct 2023 |
| Anticipate | Asieris Pharmaceutical | APL-1202 (MetAP2 inhibitor) + tislelizumab in neoadjuvant MIBC | 632 | Toplined positive for pCR vs tislelizumab, Sep 2023 |
Note: *NHT=novel hormonal therapy, ie, Xtandi, Zytiga or similar. Source: ASCO.
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