Chugai To Develop Promising PI3K Inhibitor For Breast Cancer In Japan

Chugai Pharmaceutical Co., Ltd. announced the signing of a license agreement with F. Hoffmann-La Roche Ltd (Roche) [Head Office: Basel, Switzerland. Thomas Schinecker] for the PI3K alpha inhibitor inavolisib. This drug is being developed to treat advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation, in combination with palbociclib and fulvestrant. Under this agreement, Chugai has secured exclusive development and marketing rights for inavolisib in Japan. In return, Roche will receive an upfront fee and milestone payments.

Chugai’s President and CEO, Dr. Osamu Okuda, said that “PIK3CA mutations are detected in approximately 40%1 of patients with hormone receptor (HR)-positive breast cancer. Patients with PIK3CA mutated HR-positive, HER2 negative advanced BC have a poorer prognosis and thus there remains a significant unmet need for this patient group. Inavolisib, which has shown positive data in global clinical trials, is expected to be a new treatment option for patients with breast cancer. Chugai will work closely with Roche to conduct domestic development in order to bring inavolisib to patients with breast cancer as soon as possible.”

Genentech, part of the Roche Group, discovered inavolisib, which is now in global Phase III trials for locally advanced or metastatic HR-positive/HER2-negative breast cancer with PIK3CA mutations (INAVO120 and INAVO121) and for PIK3CA mutated HER2-positive breast cancer (INAVO122). The INAVO120 trial showed that the inavolisib-based regimen, combined with palbociclib and fulvestrant, more than doubled progression-free survival, reducing the risk of disease progression or death by 57% compared to palbociclib and fulvestrant alone (15.0 months vs. 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p<0.0001). The regimen was well tolerated with a manageable safety profile.

Following the positive INAVO120 results, inavolisib received Breakthrough Therapy Designation for HR-positive, HER2-negative locally advanced or metastatic breast cancer with PIK3CA mutations in the first-line setting, as well as Priority Review by the U.S. FDA, with a PDUFA date of November 27, 2024. Chugai will leverage Roche Group's research and development resources to discover innovative new drugs and address unmet medical needs.