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A year ago, data from the Lorelei trial on the taselisib aspirator, Roche's PI3K inhibitor, finally failed and the project was abandoned. Today, at Esmo, Novartis has unveiled the full results of the Solar-1 trial of its rival alpelisib, described as a revolutionary practice by physicians.
The data were for second-line breast cancer positive for HR, Her2, a disease with a relatively good prognosis. Nevertheless, Dr. Fabrice André of the Gustave Roussy Institute described alpelisib as a "true targeted therapy".
The reason for this optimism was that while Solar-1 recruited all candidates, an effect was observed only in subjects with the PIK3CA mutation that is the target of PI3K inhibitors. Anticipating such an effect, the doctors decided to use as a primary evaluation criterion of Solar-1 a specific progression-free survival in patients mutated with PIK3CA.
This showed that alpelisib offered a 5.3-month control advantage, resulting in a 35% reduction in the risk of progression, with a statistically significant p-value of 0.00065. "There was no effect in patients without PIK3CA mutations," said Dr. Andre at this morning's press conference.
Only 232 of the 572 patients enrolled in Solar-1 were carriers of the mutation. The decision regarding the statistical analysis therefore raises questions as to the ethics of treating so many non-mutant patients with supposedly ineffective treatment.
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