Roche Korea announced on July 30 that it has received approval of the breast cancer treatment Itovebi (inavolisib) from the Ministry of Food and Drug Safety.

Itovebi, recently approved, can be used for the treatment of PIK3CA mutation-positive, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients.

Itovebi is indicated to be used in combination with palbociclib and fulvestrant therapy in adult patients with locally advanced or metastatic HR+, HER2-, and PIK3CA gene mutation-positive breast cancer that has recurred within 12 months during or after adjuvant endocrine therapy.

For patients with a history of CDK4/6 inhibitor treatment as adjuvant therapy, it must be more than 12 months since the end of the CDK4/6 inhibitor treatment. For premenopausal and male patients, LHRH agonists are co-administered.

Hormone receptor-positive breast cancer is the most common type, accounting for approximately 60% of all breast cancers, and about 40% of these are estimated to have a PIK3CA gene mutation.

Activation of the PIK3CA mutation results in the dysregulation of the PI3K signaling pathway. Thus, existing treatments alone are often insufficient, resulting in a poor prognosis.

The current approval is based on the Phase 3 INAVO120 study, which confirmed the clinical utility and safety of Itovebi.

In 161 patients with locally advanced or metastatic HR+, HER2-, and PIK3CA mutation-positive breast cancer whose disease progressed within 12 months during or after adjuvant endocrine therapy, and who had no prior systemic treatment, Itovebi in combination with palbociclib and fulvestrant therapy showed a significant overall survival (OS) benefit compared to the control group (n=164) receiving placebo in combination with palbociclib and fulvestrant.

Additionally, a median follow-up of 34.2 months, the median overall survival (OS) for the Itovebi treatment group was 34 months (95% CI, 28.4-44.8), and the risk of patient death was reduced by 33%.

In contrast, the median overall survival for the control group (at a median follow-up of 32.3 months) was 27 months.

Professor Seock-ah Im of Seoul National University Hospital's Department of Hemato Oncology, who led the INAVO120 study, explained, "The PIK3CA mutation promotes tumor growth and rapidly progresses the disease, which can lead to a poor prognosis, thus creating a significant unmet need for new treatments in this area." She added, "Itovebi has not only confirmed more than double the extension of progression-free survival (PFS) compared to existing standard therapies in patients with PIK3CA mutations, but it is also the only PI3K inhibitor to confirm overall survival extension."

Ezat Azem, CEO of Roche Korea, said, "We are pleased to provide a new first-line treatment option for domestic PIK3CA gene mutation breast cancer patients, for whom treatment options have been limited," and added, "As a leader in breast cancer treatment, we will continue to contribute to the advancement of the breast cancer treatment environment in Korea."

Meanwhile, Itovebi is Roche's first targeted therapy in the hormone receptor-positive field, following its leading position in HER2+ breast cancer treatment with Herceptin, Kadcyla, Perjeta, and Phesgo.

Itovebi received Breakthrough Therapy designation from the U.S. FDA in May 2024 and FDA approval in October of the same year.