Olema set for an operatic debut at last

The pivotal Opera-02 study of Olema's palazestrant in first-line breast cancer can proceed at last, after the company today secured $250m in a placement from select private investors. The study, combining the so-called CERAN/SERD (complete ER antagonist and selective ER degrader) project palazestrant with Novartis's Kisqali, had first been mooted back in October 2022, and had once been expected to start last year, but was always dependent on additional financing. Now that funding is secured Opera-02 will start in mid-2025, Olema says. This is progress at last, but it's notable that Olema has fallen behind other major SERD players in going into front-line disease. Palazestrant has already been studied in combination with Kisqali in later-line breast cancer, and this link has long fuelled investor hopes that the Swiss company will end up buying Olema to secure Kisqali, which is becoming the CDK4/6 inhibitor of choice. Though Opera-02 will be run under a clinical trial agreement with Novartis, as far as a more permanent tie-up goes the Swiss firm has secured only rights of first negotiation over licensing palazestrant, suggesting that it's in no hurry to pull the acquisition trigger.

Oral SERDs in phase 3 development for 1st-line ER-positive/HER2-negative breast cancer

Source: OncologyPipeline.