ASCO25: Roche’s Itovebi combo reduces threat of demise in breast most cancers by 33%
Roche’s blockbuster imaginative and prescient for phosphoinositide 3-kinase (PI3K inhibitor) Itovebi (inavolisib) has been dealt a lift after the drug demonstrated additional optimistic total survival (OS) knowledge in a typical subtype of breast most cancers.
Together with Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and anti-oestrogen drug Faslodex (fulvestrant), Itovebi lowered the chance of demise by 33% in sufferers with PIK3CA-mutated, HR-positive, HER2-negative domestically superior or metastatic breast most cancers that has grown throughout or after hormone remedy remedy.
The brand new OS outcomes got here from the Part III INAVO120 examine (NCT05646862) evaluating the triple remedy in comparison with Ibrance and Faslodex alone. Roche revealed an summary containing the info forward of a presentation on the American Society of Scientific Oncology (ASCO) 2025 assembly happening from 30 Might to three June in Chicago, Illinois.
Itovebi received US Meals and Drug Administration (FDA) approval on this breast most cancers indication based mostly on INAVO120’s knowledge late final yr, though full evaluation of the OS has solely been accomplished by Roche now.
The examine, which enrolled 325 sufferers, noticed Roche’s Itovebi mixture led to a median OS of 34 months in comparison with 27 months for individuals who took a placebo together with Ibrance and Faslodex. The median follow-up was slightly below three years.
The outcomes consolidate earlier knowledge that confirmed including Itovebi to the remedy routine greater than doubled progression-free survival (PFS) to fifteen months. With the total evaluation now obtainable, Roche has up to date this to 17.2 months, in comparison with the 7.3 months within the comparator arm.
Coupled with the OS knowledge, the outcomes are a landmark second within the P13KCA panorama. No different pharma firm has developed a candidate that reaches the 33% Itovebi has achieved. For instance, rival PI3K inhibitor Piqray developed by Novartis, failed to provide a statistically vital distinction in OS in breast most cancers sufferers with a PIK3CA mutation. Piqray is FDA-approved as a second-line remedy possibility, whereas Itovebi is a first-line remedy.
HR-positive, HER2-negative breast most cancers is the most typical subtype of breast most cancers. About 40% of those sufferers have a mutation within the PIK3CA gene.
PI3K inhibitors have lengthy been troubled by security issues. Roche’s Itovebi isn’t any completely different, with 90.7% of sufferers experiencing Grade 3 or 4 antagonistic occasions (AEs). Nonetheless, a excessive price was additionally seen within the placebo/Ibrance/Faslodex arm – 84.7%. Hyperglycaemia was an AE singled out within the evaluation, being notably prevalent within the Itovebi group at 63.4%, versus 13.5% within the different arm.
Backed by earlier survival knowledge, Roche has excessive hopes for Itovebi, forecasting peak gross sales of $2.3bn. Evaluation by GlobalData, which matches as much as 2031, has forecast peak gross sales of $1.4bn.
GlobalData is the mother or father firm of Pharmaceutical Know-how and Scientific Trials Enviornment.
“The INAVO120 trial has recognized a focused remedy routine that meaningfully improves survival in sufferers with untreated PIK3CA-mutated hormone receptor-positive metastatic breast most cancers – a giant step ahead for these sufferers,” stated Jane Lowe Meisel, co-director of Breast Medical Oncology on the Winship Most cancers Institute of Emory College Faculty of Drugs, and an ASCO Skilled in breast most cancers.
“This examine illustrates the significance of genomic testing on the time of prognosis of hormone receptor-positive metastatic breast most cancers in order that sufferers with PIK3CA mutations who qualify for this method will be readily recognized.”
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