Novartis AG’s drug Kisqali reduced the risk of tumors recurring by 25% in a study that will help determine how patients with the most common form of breast cancer are treated.
(Bloomberg) — Novartis AG’s drug Kisqali reduced the risk of tumors recurring by 25% in a study that will help determine how patients with the most common form of breast cancer are treated.
Nine out of 10 people who got Kisqali as well as hormonal therapy after surgery were disease-free after three years, compared with 87% of those given just hormonal therapy, according to trial results presented on Friday at the American Society of Clinical Oncology’s annual meeting.
The 5,100-person study, called NATALEE, revived investors’ hopes for Novartis’s drug pipeline after the Swiss company earlier this year said the results would be positive. But Kisqali is not the only treatment of its kind for early breast cancer, and analysts have said that success will depend on how it stacks up against Eli Lilly & Co.’s Verzenio.
The Novartis drug will offer an option for patients who might benefit less from Verzenio or struggle with side effects, said Rita Nanda, director of the breast medical oncology program at the University of Chicago. “It would be nice to have that option for patients.” Nanda wasn’t involved in the study.
The shares dropped following the release of the data before trading 1.3% up in Zurich.
Sales Boost?
Patients with early breast cancer could add an additional $3 billion in annual revenue for Kisqali, Novartis said. The drug generated $1.2 billion in sales last year. The company expects to have a dossier ready for regulatory submission by the end of the year, Jeff Legos, head of oncology and hematology development at Novartis, said in a briefing with reporters.
Still, the results fall short of what some analysts had said would be needed to make Kisqali as competitive as possible. A base-case scenario would have been risk reduction of 30% to 35%, Peter Welford, an analyst at Jefferies, said in a note to investors before the study details were released. “At first glance,” efficacy appears to fall below that level, Welford said in an update on Friday. However, he said the benefit across different groups of patients is encouraging.
Lilly’s competing drug reduced the risk of cancer coming back by 35% after four years of follow-up. It requires two years of therapy, a year shorter than the Novartis medicine.
The longer treatment duration was intentional to disable as many lingering cancer cells as possible, Legos said in an interview. He argued that Kisqali could benefit the full spectrum of patients included in the study, in part because of a low rate of gastro-intestinal side effects such as uncontrollable diarrhea.
“What’s important for these patients is to, one, be able to take their therapy, two, be able to stay on their therapy, and three, be able to continue without any disruption to their ongoing daily lives,” Legos said. “That’s what Kisqali could afford these patients.”
The Novartis trial also included a broader population of patients than Lilly’s study, in particular those whose cancer hadn’t spread to their lymph nodes. The benefit in that subset of lower-risk patients appeared to be consistent, though the results weren’t statistically significant because the patient group was small, Legos said.
Researchers will keep following trial participants to see how the difference develops over time and whether the combination can extend patients’ lives.
(Updates with regulatory timing in the sixth paragraph, analyst comment in the seventh)
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