One of Ipsen’s flagship oncology assets Cabometyx (cabozantinib) will not be gaining an indication in prostate cancer outside the US or Japan after a Phase III trial failed to meet one of its primary endpoints.
Ipsen’s CONTACT-02 trial (NCT04446117), investigating Cabometyx in combination with Roche’s Tecentriq (atezolizumab) in metastatic castration-resistant prostate cancer (mCRPC), did not meet statistical significance in overall survival (OS) improvement at 24 months, as per a 15 September press release.
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The French biopharma said that based on these results and the “challenging regulatory environment”, it would not be pursuing regulatory submissions for the combination therapy in mCRPC.
Ipsen has commercialisation and development rights for the drug in countries outside the US and Japan following a 2016 deal with Cabometyx’s original developer Exelixis. While Exelixis kept hold of US rights, it granted Japanese duties to Takeda in 2017.
Ipsen has overseen approvals in renal cell carcinoma, thyroid carcinoma, and hepatocellular carcinoma indications for Cabometyx in territories outside the US and Japan. The company says that these indications are in over 60 countries, including in the EU.
The tyrosine kinase inhibitor (TKI) brought in $579m for Ipsen last year, with peak sales projected to reach $826m in 2028, according to GlobalData’s Pharma Intelligence Center.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
The CONTACT-02 trial aimed to add a prostate cancer arrow to Cabometyx’s oncology quiver, comparing the combo therapy to a second novel hormonal therapy (NHT) in men previously treated with one NHT and measurable soft-tissue disease.
Prostate cancer is the second most common cancer in men and the fourth most common cancer overall globally. Prostate cancer is considered mCRPC when it has spread beyond the prostate and androgen-suppression therapies, a common treatment for the disease, do not work.
The global study, which enrolled 575 patients, got off to a good start when it met its other primary endpoint of progression-free survival last year. Those receiving the combo went 6.3 months without disease progression versus 4.2 months in the control group.
There were no new safety signals identified from the study’s data either – the combo’s safety being consistent with the known profiles of the individual medicines. The miss on the OS endpoint means though that Cabometyx’s race in prostate cancer is run for Ipsen.
Ipsen said it remains confident in the use of Cabometyx as a monotherapy and with immunotherapy combinations across approved indications, as well as the drug’s ongoing future potential.
Despite the missed endpoint, Exelixis stated in its press release that improvement in OS was still seen in multiple clinical subgroups. The company added that it will press ahead with a supplemental new drug application to the US Food and Drug Administration (FDA) for the combo therapy in mCRPC, with the submission occurring later this year.
Exelixis’s chief medical officer Amy Peterson said: “The results from the CONTACT-02 trial suggest that there are patients who could benefit from Cabometyx in combination with Tecentriq and that this regimen could be a valuable addition to the treatment landscape for patients with advanced prostate cancer.”
