Novartis has tested its drug Kisqali in a Phase III trial to treat patients with HR+/HER2- advanced breast cancer, as detailed in a press release. The findings determined a prolongation of the overall survival rate when Kisqali was administered together with Fulvestrant in postmenopausal women suffering from HR+/HER2- advanced or metastatic breast cancer.
Novartis explained that the MONALEESA-3 study is already the second Phase III clinical trial in which the key secondary endpoint of overall survival has been achieved. The Basel-based pharma group will now present the findings to the relevant regulatory authorities. Kisqali has already been authorized for use in various indications in more than 75 countries around the world.
Furthermore, Roche – also headquartered in Basel – reported positive study data too. The drug Tecentriq was used in the Phase III study to treat patients with advanced bladder cancer. The platinum-based chemotherapy reduced the risk of previously untreated advanced bladder cancer worsening or leading to death when administered in combination with Tecentriq. In the press release, Sandra Horning, M.D., Chief Medical Officer at Roche, explains that the IMvigor130 study was the first positive Phase III trial of a cancer immunotherapy combination in previously untreated advanced bladder cancer. She stated that this represents confirmation of Roche’s approach of combining immunotherapy with chemotherapy or other treatments.
Roche will now also present its findings from this study to the regulatory authorities – in this instance the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).