Roche Faces Major Challenge: Can New Drug Itovebi Stand Out in the CHF 2 Billion Market?

As Roche faces increasing market competition in its breast cancer treatments, the company is eager for its new drug to breathe new life into its once-stellar portfolio and generate up to 2 billion Swiss francs in additional revenue. The drug, called inavolisib, has been approved by the U.S. Food and Drug Administration (FDA) and is designated to treat HR-positive, HER2-negative breast cancer patients with PIK3CA mutations who have developed resistance to adjuvant endocrine therapy. As an oral drug, inavolisib will be used in combination with Pfizer's Ibrance and Astrazeneca's Faslodex in hopes of achieving better therapeutic outcomes.

Roche plans to market inavolisib under the brand name Itovebi, which will compete directly with Novartis' PI3K inhibitor Piqray and Astrazeneca's AKT inhibitor Truqap. Despite the fierce competition in the market, Roche executive Teresa Graham remains confident about Itovebi's market prospects, predicting peak sales of 2 billion Swiss francs ($2.3 billion).

During an investor call in April, Graham presented this sales forecast, explaining that PIK3CA mutations occur in about 40 percent of HR-positive breast cancer patients and that she believes inavolisib is a more effective drug than Piqray. Charlie Fuchs, MD, head of global product development for oncology and hematology at Roche subsidiary Genentech, noted in an interview with Fierce Pharma that while the existence of the PIK3CA mutation has been known for decades, But surprisingly, it has been difficult to treat because many of the drugs that have been developed have limited efficacy and are poorly tolerated.

Dr. Fuchs emphasized that Itovebi has the best potential in its class from both a efficacy and safety perspective. The drug has strong data to support its efficacy. In the Phase 3 INAVO120 trial, adding Itovebi to the regimen of Ibrance and Faslodex significantly reduced the risk of disease progression or death by 57 percent. Patients in the Itovebi group had disease without progression for an average of 15 months, compared with 7.3 months in the control group. The study specifically enrolled patients with tumors with PIK3CA mutations that rapidly progressed after postoperative endocrine therapy and were thought to be resistant to endocrine therapy.