Ipsen provides update on CONTACT-02 Phase III study in metastatic castration-resistant prostate cancer following final analysis of overall survival Page 1

• Study examines Cabometyx (Cabozantinib) in combination with atezolizumab showed a positive trend towards improving one of the primary endpoints of overall survival, but did not reach statistical significance
• Ipsen will not submit marketing applications for the combination therapy in countries where we have commercialization rights (outside the United States and Japan).
• We remain confident in the proven profile of Cabometyx as monotherapy and in combination with immunotherapy in all approved and potential future indications.

PARIS, FRANCE, September 15, 2024 – Ipsen (Euronext: IPN; ADR: IPSEY) today announced detailed final overall survival (OS) data from the Phase III CONTACT-02 study evaluating the combination of Cabometyx (cabozantinib) and atezolizumab in metastatic castration-resistant prostate cancer (mCRPC). The study evaluated the combination regimen compared to a second novel hormone therapy (NHT) in men previously treated with an NHT and with measurable soft tissue disease. At a median follow-up of 24.0 months, these data demonstrated a numerical but not statistically significant improvement in OS for the combination compared to a second NHT (hazard ratio: 0.89; 95% confidence interval: 0.72-1.10; P=0.296). As previously announced, the study met the other primary endpoint of progression-free survival (PFS), demonstrating a statistically significant benefit in PFS.¹ The safety of the combination appeared consistent with the known safety profiles of the individual drugs, and no new safety signals were identified.

Based on the results of the final OS analysis and the expected challenging regulatory environment in the countries where Ipsen has commercialization rights (outside the United States and Japan), Ipsen will not pursue regulatory filings for this combination therapy in mCRPC.

We remain confident in Cabometyx’s proven profile as monotherapy and in combination with immunotherapy across all approved indications and its continued future potential.

Ipsen would like to thank the patients, their families and medical teams for participating in this clinical trial.

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About Cabometyx

Cabometyx (cabozantinib) is a small molecule that inhibits multiple receptor tyrosine kinases, including VEGFRs, MET, RET and the TAM family (TYRO3, MER, AXL).² These receptor tyrosine kinases are involved in both normal cell function and pathological processes such as oncogenesis, metastasis, tumor angiogenesis (the growth of new blood vessels that tumors require to grow), drug resistance, modulation of immune activity, and maintenance of the tumor microenvironment.^2,3,4,5