June 1, 2019 / 12:06 PM / 3 months ago

Novartis hopes Kisqali data will help narrow gap to blockbuster rival

ZURICH (Reuters) - Novartis has released data showing sharply improved overall survival rates for its breast cancer drug Kisqali, which the Swiss drugmaker hopes will help it chip away at the dominance of Pfizer’s blockbuster Ibrance.

FILE PHOTO: The logo of Swiss drugmaker Novartis is seen at its headquarters in Basel, Jan. 25, 2017. REUTERS/Arnd Wiegmann/File Photo

Novartis’s Kisqali had $235 million in sales in 2018, well behind the $4.1 billion for Ibrance, as Pfizer’s first-to-market drug captured the lion’s share of women with metastatic HR+/HER2- cancer.

The U.S. Food and Drug Administration approved Ibrance in February 2015, two years before Kisqali.

The data released on Saturday showed about 70 percent of pre-menopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer were alive 42 months after getting a cocktail of Kisqali and endocrine therapy.

That compares with 46 percent who received only endocrine therapy, which at the time of the study was the standard of care.

Doctors helping lead Novartis’s Kisqali study, called Monaleesa-7, said the statistically significant benefit it showed was good news for patients facing a challenging disease.

“To achieve overall survival improvement in an incurable disease, like metastatic breast cancer, is truly an outstanding advancement,” said Dr. Sara Hurvitz, head of breast cancer clinical trials at the University of California Los Angeles.

According to a Refinitiv poll, analysts expect Kisqali - priced at about $130,000 per year - to reap about $1.2 billion annually by 2024.

SURVIVAL ANALYSIS

The Swiss company is hoping its new survival analysis, released at the 2019 American Society of Clinical Oncology annual meeting in Chicago, will convince more doctors to consider Kisqali.

“Most physicians would practice evidence-based medicine, and in that case, having statistical significance certainly would have some persuasion in how they would actually move forward,” John Tsai, Novartis’ head global drug developer, said on a call.

Analysis of separate clinical trials is ongoing to determine potential overall survival benefit of taking Ibrance together with endocrine therapy, as well as of endocrine therapy with a similar drug, Eli Lilly’s Verzenio, that had $255 million in sales last year.

Kisqali, Ibrance and Verzenio have not been compared with each other in trials.

In addition to losing the race to market for Ibrance, Novartis’s Kisqali has faced some safety-linked hurdles.

Its label includes warnings for a possible heart condition, called QT prolongation, and liver toxicity that require monitoring that Pfizer’s medicine has avoided.

Kisqali, a CDK4/6 inhibitor that aims to halt hyperactive cellular machinery that drives tumour growth, is approved as an initial treatment for women with HR+/HER2- advanced or metastatic breast cancer, regardless of whether they have gone through menopause.

Ibrance and Lilly’s Verzenio have somewhat narrower first-line FDA labels, covering initial therapy for HR+/HER2- breast cancer in women after menopause.

Reporting by John Miller; Editing by David Holmes

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