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) extended.
but the study did not reach another common primary endpoint for extending rPFS, so overall it was mixed.
IPATential 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 adult male patients with asymptomatic or mild symptoms and previously untreated mCRPC. The common primary endpoints of the
study included rPFS throughout the study population, as well as rPFS in subpopulations that assessed their PTEN gene deficiency through immunohistochemical chemistry.
the 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 earlier.
secondary endpoints include overall survival, safety, pain progression time, cytotoxic chemotherapy start time, and functional deterioration time.
Noted that while the initial data are encouraging, the overall survival benefits and other secondary endpoint data are premature.
the trial will continue until the next analysis, and the data will be shared with health authorities.
prostate cancer is one of the most common types of cancer in men.
More than 190,000 prostate cancer patients in the United States are expected to have, according to the American Cancer Society.
Although most male patients can recover through topical therapy, relapse or newly diagnosed disease metastasis will significantly increase morbidity and mortality.
in terms of treatment, the main treatment for advanced prostate cancer includes androgen deprivation therapy (ADT), which lowers androgen levels in the body to near de-trending levels.
Although 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 mCRPC.
loss 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 stage increase, early biochemical recurrence, metastasis, and and non-dependency progression of androgens.
Ipatasertib 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, which is a key driver for the growth and proliferation of prostate cancer cells.
research on adrug treatment for AKT has been less optimistic, with GlaxoSmithKline halting the development of GSK690693 for safety reasons, and Merck MK-2206 showing poor efficacy.
the failure of these AKT inhibitors makes 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 candidate drug clinical development program focuses on tumors with PI3K/AKT pathway activation.
in addition to prostate cancer, three major studies are being conducted in several types of breast cancer, involving triple-negative breast cancer and hormone receptor-positive, human epidermal growth factor receptor-2-negative breast cancer.
expect results in the second half of 2020.
because PTEN deficiency occurs in about half of mCRPC patients, subgroups are large enough that ipatibtaser still has a commercial chance of survival.
seller consensus from EvaluatePharma, ipatasertib's revenue is expected to be $1.3 billion by 2026.
it is understood that Roche plans 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.
Reference Source: Genentech's IPA Tential 150 Study Evaluating Ipataser in Combination With With Abirateone and Prednisone/Prednisolone Met One of its Co-Primary Endpoints.