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ASCO conference: Novartis' Kisqali combo improves breast cancer survival

Novartis AG said Kisqali combination therapy showed superior effectiveness in preventing a type of breast cancer from becoming worse in a phase 3 trial.

The study, named Monaleesa-3, evaluated Kisqali and fulvestrant against fulvestrant alone in 726 postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative, or HR+/HER2-, advanced breast cancer. The study is the third phase 3 trial of Kisqali in advanced or metastatic breast cancer.

AstraZeneca PLC markets fulvestrant as Faslodex, which is already approved in the U.S. to treat breast cancer.

In the trial, patients treated with Kisqali and Faslodex lived a median 20.5 months without their cancer worsening — a metric called progression-free survival, or PFS compared to 12.8 months in patients treated with Faslodex alone.

For participants in the Kisqali-Faslodex group who had not received prior treatment, median PFS was not reached, although nearly 70% of them were estimated to remain progression-free at the median follow-up of 16.5 months. Similar patients in the Faslodex group had a median PFS of 18.3 months. The study enrolled 367 previously untreated patients.

Meanwhile, the median PFS for previously treated patients who received the combination treatment was 14.6 months, compared to 9.1 months in the Faslodex group.

Novartis said no new safety signals were observed, and that adverse events were generally consistent with previous trials.

The company is in talks with the U.S. Food and Drug Administration regarding approval for its supplemental new drug application for Kisqali-Faslodex combination therapy. The FDA has granted Kisqali, or ribociclib, breakthrough therapy status in breast cancer.

The 2018 American Society of Clinical Oncology meeting is expected to bring together more than 32,000 professionals from all over the world, with more than 2,500 study abstracts to be presented on site and an additional 3,350 abstracts to be published online.