Roche Holdings AG (OTC:RHHBY), Exelixis Inc (NASDAQ: EXEL), and Ipsen (OTC: 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.
