Third Time Lucky: Exelixis' Cabozantinib Combo Therapy Aces Pivotal Study In Prostate Cancer Patients

Roche Holdings AG RHHBYExelixis Inc EXEL, and Ipsen IPSEY say Phase 3 CONTACT-02 pivotal trial evaluating Cabometyx (cabozantinib) in combination with Tecentriq (atezolizumab) has met one of the primary endpoints.

The study demonstrated a statistically significant improvement in progression-free survival (PFS) at the primary analysis. 

CONTACT-02 is evaluating cabozantinib combined with atezolizumab compared with a second novel hormonal therapy in patients with metastatic castration-resistant prostate cancer (mCRPC) and measurable soft tissue disease previously treated with one novel hormonal therapy.

Tecentriq plus Cabometyx failed two, namely CONTACT-01 in non-small cell lung cancer and CONTACT-03 in renal cell carcinoma.

In the CONTACT-03 study, Tecentriq plus Cabometyx failed to meet its primary endpoint of overall survival at the final analysis compared to chemotherapy

The CONTACT-01 study did not meet its primary endpoint of overall survival at the final analysis

The companies say they will present the results at a later medical meeting and discuss them with regulatory authorities.

William Blair analysts Andy Hsieh and Alexandra Ramsey say they cautiously approached the top-line results given the challenges associated with treating mCRPC and multiple setbacks involving checkpoint inhibitor combinations. 

However, the results have pleasantly exceeded our expectations and the broader market's expectations.

Assuming a treatment duration of 5 months, the estimated total U.S. market value is approximately $1.9 billion, based on a net monthly cost of $17,000. They say that unless there's a considerable and meaningful reduction in disease progression or mortality, the FDA will likely demand a statistically significant survival benefit before approving, with a hazard ratio between 0.50 and 0.60.

The analysts maintain the Outperform rating on the stock.

Price Action: EXEL shares are up 1.23% at $21.36 on the last check Monday.

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareTrading IdeasGeneralExpert Ideas
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!