CDSCO Panel Approves Roche’s Protocol Amendment Proposal To Study Inavolisib in combination with Phesgo
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche’s protocol amendment proposal for the clinical trial protocol titled “A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer.”
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Inavolisib is an orally available inhibitor of phosphatidylinositol 3-kinase (PI3K), with potential antineoplastic activity. Inavolisib is a selective PI3K-p110α (PIK3CA) inhibitor, which may offer antineoplastic functionality. Therefore, it may serve as a new addition to combination therapy with conventional cancer treatment, such as chemotherapy.
Phesgo is a fixed-dose combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous (SC; under the skin) injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer.
The mechanisms of action of Perjeta and Herceptin are believed to complement each other, as both bind to the HER2 receptor, but to different locations. The combination of Perjeta and Herceptin is thought to provide a more comprehensive, dual blockade of HER signalling pathways, thus preventing tumour cell growth and survival. The hyaluronidase in Phesgo temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin, enabling Phesgo to be rapidly dispersed and absorbed over a greater area.
Phesgo offers faster administration of Perjeta and Herceptin under the skin in just minutes, compared to hours with standard IV administration. Phesgo can be administered by a healthcare professional in a treatment centre or at a patient’s home.
At the recent SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the protocol amendment version 2.0 dated 30.01.2024 protocol no. WO44263 presented by the drug major Roche.
