Zanzalintinib's second-wave push
Although Exelixis has faced toxicity problems with its Cabometyx follow-on zanzalintinib, it's pressing ahead with an ambitious expansion plan for this asset. By the end of the year Exelixis hopes to have secured US approval in third-line colorectal cancer. It's also awaiting pivotal data in first-line renal cell carcinoma, where zanzalintinib is being tested alongside Opdivo. And recently the company launched what it describes as a second wave of pivotal development. Stellar-311 tests zanzalintinib against Afinitor in neuroendocrine tumours. Litespark-033 is evaluating the drug in combination with Merck & Co's Welireg against Cabometyx in renal cancer patients who have previously received PD-(L)1 inhibitors. And Exelixis wants to start three more trials this year: in colorectal cancer Stellar-316 will assess zanzalintinib in MRD-positive patients who have no radiographic evidence of disease; Stellar-201, a phase 2 study, will evaluate zanzalintinib monotherapy in grade I-III meningioma patients who have relapsed or progressed following surgery or radiation; the third trial will be another combination with Welireg, but all Exelixis said during its fourth-quarter earnings was that further information on this would be provided in the coming months.
Zanzalintinib's pivotal trials
| Study | Indication | Regimen | Status |
|---|---|---|---|
| Stellar-303 | 3rd-line colorectal cancer | + Tecentriq, vs Stivarga | FDA filing accepted; PDUFA date 3 Dec 2026; final OS data in non-liver mets pts due mid-2026 |
| Stellar-304 | 1st-line renal cancer | + Opdivo, vs Sutent | Data due mid-2026 |
| Stellar-311* | 1st-line neuroendocrine tumours | Vs Afinitor | Primary completion date Jun 2029 |
| Litespark-033 | Post adjuvant PD-(L)1 renal cancer | + Welireg, vs Cabometyx | Primary completion Feb 2032 |
| Stellar-201** | Meningioma | Monotherapy | To start in mid 2026 |
| Stellar-316 | Adjuvant colorectal cancer | Monotherapy | To start in mid 2026 |
| NA | Renal cancer | + Welireg | Additional info expected in 2026 |
Note: *phase 2/3 trial; **phase 2 trial. Source: OncologyPipeline.
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