Roche wins first-line breast cancer contract for oral PI3K blocker, forecasting peak sales of $2.3 billion

The FDA on Thursday approved RochePfizer’s Inavolisib – now marketed as Itovebi – is intended for the first-line treatment of certain breast cancer patients in combination with Pfizer’s Ibrance and AstraZeneca’s Faslodex.

The Itovebi combination is specifically indicated for adult patients with endocrine-resistant, PIK3CA-mutant, HR-positive and HER2-negative locally advanced or metastatic breast cancer. approval on Thursday comes more than a month in advance the original target date for the treatment regimen, which was supposed to be November 27th.

Roche CMO Levi Garraway said in a statement that Itovebi’s approval will provide “an important new first-line option” for patients with HR-positive breast cancer that carries the PIK3CA mutation. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options remain limited, making today’s approval even more significant,” Garraway added.

The approval of Itovebi was supported by data from the Phase III INAVO120 trial, a randomized, double-blind, placebo-controlled trial that evaluated the combination regimen compared to Ibrance and Faslodex in combination with placebo. In December 2023, Roche published results of INAVO120, advertises a 57% reduction the risk of disease progression or death in patients treated with Itovebi compared to placebo comparators. The pharmaceutical company stated at the time that this effect was statistically significant with a p-value of less than 0.0001.

Overall survival data were still immature at the primary analysis, but the numbers showed a “clear positive trend” in favor of the Itovebi arm.

In terms of safety, INAVO120 noted that the Itovebi combination is well tolerated with side effects consistent with the toxicity profiles of each therapy. The dropout rate in the Itovebi arm was 6.8%, compared to 0.6% in the placebo comparison group.

Garraway said at the time that these data indicated the Itovebi regimen’s potential to “become a new standard of care for this patient population,” noting that inavolisib – through work on the PI3K pathway – “is the way in which Breast cancer treatment could change “in patients whose tumors have PIK3CA mutations.”

Developed for oral use, Itovebi is a small molecule blocker of the PI3K protein, which plays a key role in cell growth, proliferation, differentiation and survival. According to his labelThe mechanism of action of Itovebi allows the suppression of tumor growth and, when combined with Ibrance and Faslodex, can produce a much stronger anti-cancer effect compared to each treatment alone or in combination with each other.

With Thursday’s approval, Roche enters the PI3K arena, potentially posing a challenge to Novartis, its oral drug Piqray (Alpelisib) was approved by the FDA in 2019 for the same indication. In 2023, Piqray made $505 million of income.

Teresa Graham, CEO of Roche Pharmaceuticals, puts Itovebi’s maximum sales potential at $2.3 billion.