Exelixis’ second-quarter earnings report revealed a primary endpoint statistical significance failure, a potential market launch into a new indication and an ADC cut.
Despite Cabometyx plus Roche’s Tecentriq missing a primary endpoint in a prostate cancer trial, Exelixis said it will still submit a supplemental NDA later this year. The company is also preparing for a Cabometyx launch in neuroendocrine tumors (NETs) next year.
The Phase 3 CONTACT-02 trial recruited 507 people with metastatic castration-resistant prostate cancer (mCRPC) and soft tissue disease who have progressed after one prior hormonal therapy. Although Cabometyx plus Tecentriq showed a favorable trend in the overall survival primary endpoint, it did not hit statistical significance, according to the company’s second-quarter earnings release.
The outlook for Cabometyx in prostate cancer is “more uncertain” given the lack of OS benefit, TD Cowen analysts said.
The California biotech previously unveiled data from the Phase 3 trial’s other primary endpoint of progression-free survival in January. These showed that Cabometyx plus Tecentriq achieved a median 6.3-month improvement in PFS versus 4.2 months for hormonal therapy (p=0.0007), according to a separate release.
Meanwhile, the FDA has accepted a separate sNDA for Cabometyx in advanced NETs with a PDUFA date set for April 3 next year. Jefferies analysts said that the potential approval in NETs should boost topline growth with minimal spend for Exelixis because there’s already an overlap between providers who prescribe Cabometyx and those who treat NETs.
The MET inhibitor pulled $433.3 million in Q2 revenues in the US, with Exelixis earning a further $41.2 million in royalties and a $150 million commercial milestone payout from its Cabometyx partner Ipsen. Exelixis has exclusive rights to develop and commercialize Cabometyx in the US but has out-licensed it in other markets.
Cabometyx first won FDA approval for advanced renal cell carcinoma back in 2016, with subsequent label expansions to hepatocellular carcinoma and certain forms of thyroid cancer.
Elsewhere in Exelixis’ pipeline, it said it is dropping the tissue factor-targeting ADC, dubbed XB002, as part of broader portfolio prioritization. The company said data so far show the treatment is unlikely to improve upon other candidates with the same mechanism that is in development. Exelixis will disclose results from the Phase 1 trial of XB002 in solid tumors at a later date.
Editor’s note: This article was updated to correct that Cabometyx was in combination with Tecentriq and not Keytruda.