Bangbungcau evaluating inavolisib-based combinations sampeuatah

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Business Description

These include the INAVO121 trial (NCT05646862), which is evaluating the agent in combination with fulvestrant vs alpelisib (Piqray) plus fulvestrant in hormone receptor–positive, HER2-negative breast cancer following progression on a CDK4/6 inhibitor and endocrine therapy; the INAVO122 study (NCT05894239) investigating inavolisib plus a subcutaneous fixed dose of pertuzumab (Perjeta) and trastuzumab (Herceptin) as maintenance therapy in HER2-positive disease; and the INAVO123 study (NCT06790693) evaluating first-line inavolisib plus a CDK4/6 inhibitor and letrozole in endocrine-sensitive, PIK3CA-mutated hormone receptor–positive, HER2-negative breast cancer.

Additional studies of inavolisib in breast cancer and other tumor types are planned, with the aim of extending the agent’s benefit to more people with PIK3CA-mutated cancers.

Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) has received FDA approval for the treatment of unresectable or metastatic, hormone receptor–positive breast cancer with HER2-low (IHC 1+ or 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) expression, as determined by an FDA-approved test, in patients who have experienced disease progression on 1 or more prior lines of endocrine therapy in the metastatic setting.1

This regulatory decision was supported by findings from the phase 3 DESTINY-Breast06 trial (NCT04494425), in which treatment with T-DXd generated a 36% reduction in the risk of disease progression or death compared with chemotherapy (HR, 0.64; 95% CI, 0.54-0.76; P < .0001) in the overall population of patients with chemotherapy-naive HER2-low -ultralow metastatic breast cancer.1,2 The median progression-free survival (PFS) was 13.2 months (95% CI, 12.0-15.2) with T-DXd vs 8.1 months (95% CI, 7.0-9.0) with chemotherapy. Additionally, the confirmed overall response rate (ORR) was 62.6% with T-DXd compared with 34.4% with chemotherapy.

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