Broad Therapy Record: Successful FDA Approval for Roche-Itovebi Combination

The U.S. regulatory authority FDA has granted approval for the use of Roche's Itovebi (Inavolisib) in combination with Pfizer's Ibrance (Palbociclib) and AstraZeneca's Faslodex (Fulvestrant) as a first-line treatment for specific breast cancer conditions. This combination therapy is authorized for patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, and HER2-negative locally advanced or metastatic breast cancer—however, only after the recurrence of the disease following adjuvant endocrine therapy. Itovebi's main competition is Novartis' Piqray (Alpelisib), which was already approved by the FDA in 2019. Despite Piqray's head start, GlobalData predicts that Itovebi's sales will surpass those of Piqray in the coming years. It is expected that Itovebi will generate over $1 billion by 2030, while Piqray is projected to reach approximately $480 million in the same timeframe. The basis for the FDA approval is the INAVO120 study, a placebo-controlled Phase III trial involving 325 breast cancer patients. According to Roche, the progression-free survival (PFS) with the Itovebi combination therapy averaged 15 months, compared to a PFS of 7.3 months in the placebo group receiving Ibrance and Faslodex. While the overall survival rate data were not yet complete, they still showed a "clear positive trend" in favor of the Itovebi combination. Secondary endpoints, such as objective response rate (ORR), duration of response (DoR), and clinical benefit, demonstrated improvements, although Roche did not provide detailed information on these. The most common serious side effects included hematological abnormalities like neutropenia, thrombocytopenia, and anemia, hyperglycemia, and stomatitis. The discontinuation rate was 6.8% in the Itovebi group compared to 0.6% in the placebo group. Roche plans to expand the application field of Itovebi in breast cancer. An ongoing Phase III study (INAVO121) is comparing the use of Itovebi with Piqray in combination with Faslodex in HR-positive/HER2-negative breast cancer after prior therapy with a CDK4/6 inhibitor. Another Phase III INAVO122 project is examining Itovebi combined with Phesgo as a maintenance therapy following induction therapy in untreated HER2-positive advanced breast cancer.