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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 IndicationRegimenStatus
Stellar-3033rd-line colorectal cancer+ Tecentriq, vs StivargaFDA filing accepted; PDUFA date 3 Dec 2026; final OS data in non-liver mets pts due mid-2026 
Stellar-3041st-line renal cancer+ Opdivo, vs SutentData due mid-2026
Stellar-311*1st-line neuroendocrine tumoursVs AfinitorPrimary completion date Jun 2029
Litespark-033Post adjuvant PD-(L)1 renal cancer+ Welireg, vs CabometyxPrimary completion Feb 2032
Stellar-201**MeningiomaMonotherapyTo start in mid 2026
Stellar-316Adjuvant colorectal cancerMonotherapyTo start in mid 2026
NARenal cancer+ WeliregAdditional info expected in 2026

Note: *phase 2/3 trial; **phase 2 trial. Source: OncologyPipeline.