Mixed joys and sorrows! Roche's ipatasertib stage 3 prostate cancer reaches a primary end point

Roche's Genetek recently announced that phase 3 clinical research IPATential 150 has reached a common primary endpoint, compared with the current standard of care (Abitron and Pernison/Banisonron) plus placebo, the ipataser joint care standard program makes the cancer-suppressing gene PTEN missing metastatic demetmatod prostate cancer (mCRPC) patients with radiation non-progression survival (rCRS) extendedBut the study did not reach another common primary endpoint for extending rPFS, so overall it was mixedIPATential 150 is a double-blind, placebo-controlled, randomized phase 3 clinical study of 1101 male patients in the group, evaluating the efficacy and safety of iptasertib in combination with the Standard Care Program in patients with asymptomatic or mild symptoms, previously untreated mCRPC adult male patientsThe common endpointofay of the study included rPFS throughout the study population, and rPFS in subgroups that assessed their PTEN gene deficiency through immunohistochemical evaluationThe PFS in the study is defined as the time from the random group date to the first time the disease progresses or dies of any cause, whichever is earlierSecondary endpoints include overall survival, safety, pain progression time, cytotoxic chemotherapy start time, and function deterioration time, Genetek, noted that while the initial data are encouraging, the overall survival benefits and other secondary endpoint data are prematureThe trial will continue until the next analysis, and the data will be shared with health authoritiesprostate cancer is one of the most common types of cancer in menThere are an estimated 190,000 prostate cancer patients in the United States, according to the American Cancer SocietyAlthough most male patients can recover through topical therapy, recurrence or newly diagnosed disease metastasis will significantly increase morbidity and mortalityIn terms of treatment, the main treatment symplithement for advanced prostate cancer includes androgen deprivation therapy (ADT), which lowers androgen levels in the body to near de-potential levelsAlthough most patients with metastatic prostate cancer initially respond to ADT, other effective treatments are still needed as drug resistance develops and the disease develops to mCRPCloss of tumor-suppressing protein PTEN in about 40%-60% of mCRPC patients, which leads to overactivation of the PI3K/AKT pathway and is associated with many adverse outcomes, such as tumor classification and staging, early biochemical recurrence, metastasis, and the progression of androgen synthasiIpatasertib is an oral, highly specific research drug designed to target and bind to all three subtypes of AKT (i.e., protein kinase B), which block the PI3K/AKT signaling pathway, a key driver for the growth and proliferation of prostate cancer cellsresearch on drug therapy for AKT has been less optimistic, glaxoSmithKline stopped the development of GSK690693 for safety reasons, and Merck MK-2206 has shown poor efficacyThe failure of these AKT inhibitors has made ipatasertib the frontrunner in the field, and Roche's biggest competitor is AstraZeneca's small molecule, Capivasertib Ipatasertib was discovered by Genentech and Array BioPharma, which was acquired by Pfizer in July 2019 Currently, the clinical development program of the candidate drug focuses on tumors with PI3K/AKT pathway activation In addition to prostate cancer, three major studies are under way in several types of breast cancer, involving triple-negative breast cancer and hormone receptor-positive, human epidermal growth factor receptor-2-negative breast cancer Results are expected in the second half of 2020 Since PTEN deficiency occurs in about half of mCRPC patients, subgroups are large enough that ipatasertib can still have a commercial chance of survival The seller's consensus from EvaluatePharma shows that ipatasertib's revenue is expected to be $1.3 billion by 2026 Roche is understood to have planned to submit an application for the drug to treat prostate and breast cancer this year However, without further support for the overall population benefit, there must be a need to change the standard of treatment so that prostate cancer patients treated with ipatasertib must undergo PTEN testing, so the situation of ipatasertib is still not entirely optimistic .