With the regulatory approval for advanced breast cancer, Roche’s inavolisib is a potential challenger to Novartis’ PI3K inhibitor Piqray, which last year generated $505 million in revenue.
The FDA on Thursday approved Roche’s inavolisib—now to be marketed as Itovebi—for the first-line treatment of certain breast cancer patients in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex.
The Itovebi combo is specifically indicated for adult patients endocrine-resistant, PIK3CA-mutated, HR-positive and HER2-negative locally advanced or metastatic breast cancer. Thursday’s approval comes more than a month ahead of the original target action date for the treatment regimen, which was supposed to be on Nov. 27.
Levi Garraway, Roche CMO, in a statement said that Itovebi’s approval will offer “an important new first-line option” for patients with HR-positive breast cancer harboring the PIK3CA mutation. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes today’s approval all the more significant,” Garraway added.
Itovebi’s approval was backed by data from the Phase III INAVO120 study, a randomized, double-blinded and placebo-controlled trial that evaluated the combo regimen versus Ibrance and Faslodex combined with placebo. In December 2023, Roche released results from INAVO120, touting a 57% reduction in the risk of disease progression or death in patients treated with Itovebi versus placebo comparators. This effect was statistically significant, with a p-value less than 0.0001, the pharma noted at the time.
Overall survival data were still immature by the primary analysis, but figures showed a “clear positive trend” in favor of the Itovebi arm.
In terms of safety, INAVO120 found the Itovebi combo to be well-tolerated, with adverse events that were consistent with the toxicity profiles of the individual therapies. Dropout rate in the Itovebi arm was 6.8%, compared to 0.6% in placebo comparators.
Garraway at the time said that these data point to the potential of the Itovebi regimen “to become a new standard of care in this patient population,” noting that inavolisib—by working on the PI3K pathway—“could transform the way breast cancer is treated in patients whose tumors harbor PIK3CA mutations.”
Designed to be taken orally, Itovebi is a small molecule blocker of the PI3K protein, which functions primarily in cell growth, proliferation, differentiation and survival. According to its label, Itovebi’s mechanism of action allows it to suppress tumor growth and, when used in combination with Ibrance and Faslodex, can produce a much stronger anti-cancer effect compared with each treatment alone or in doublets with each other.
With Thursday’s approval, Roche enters the PI3K arena in potential challenge to Novartis, whose oral drug Piqray (alpelisib) was approved by the FDA in 2019 for the same indication. In 2023, Piqray made $505 million in revenue.
Teresa Graham, CEO Roche Pharmaceuticals, has pegged Itovebi’s peak sales potential at $2.3 billion.
