Novartis Kisqali 6-Year Follow-Up: 19% Reduction in Death Risk for Early Breast Cancer
nashnova research
Six-year data from Novartis's NATALEE trial show Kisqali plus hormonal therapy cuts death risk by 19% versus hormones alone — and the benefit keeps widening more than three years after patients stopped taking the drug, a milestone in proving the treatment extends lives.
What does the 19% number actually mean?
Patients on Kisqali plus hormonal therapy had a six-year survival rate of 91.9%, versus 89.7% for hormones alone — a 19% reduction in the risk of death.
This means → for roughly every 100 patients, about 2 additional women were alive at the six-year mark because they received Kisqali.
The data were presented by lead NATALEE investigator Dennis Slamon at the ESMO annual meeting — one of the world's largest oncology conferences — in Madrid.
Why is the benefit still growing three years after patients stopped the drug?
The gap in invasive-disease-free survival — the share of patients with no cancer recurrence or new cancer — widened from 4.1 percentage points at five years to 5.3 percentage points at six years.
In plain terms = patients had been off the drug for over three years on average, yet the gap between treated and untreated groups was getting larger, not smaller.
This reflects a possible long-term shift in the trajectory of cancer recurrence, not just suppression while the drug is in the body.
Could the real benefit be even larger than the data suggest?
Slamon noted that some patients in the control group later received Kisqali or a similar CDK4/6 inhibitor — a class of targeted drugs that block cancer-cell division.
This means → the control group's survival rate was artificially lifted, so the true gap between the two arms may be wider than the reported numbers show.
In plain terms = the "no-drug" comparison group wasn't purely drug-free, which diluted the measured benefit of the treatment.
Which patients benefit, and what comes next?
The trial included patients at relatively lower risk of recurrence — including women whose cancer had not spread to the lymph nodes — and data showed this group benefited too.
This means → Kisqali's potential patient pool is broader than previously expected, extending beyond high-risk cases.
The next market focus: whether physicians' actual prescribing behavior shifts meaningfully after this six-year readout — that will determine the pace of Kisqali's commercial uptake.
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