Ipatasertib is a new drug in development for patients with advanced prostate cancer which has spread outside the prostate.

What is ipatasertib and who might benefit?

Ipatasertib is a new drug in development which, in the future, may be used in patients with prostate cancer in whom the cancer has spread beyond the prostate and who have already been treated with hormone therapy drugs.

Who is developing ipatasertib?

This drug is being developed by Genentech/Roche. Genentech is a US-based biotechnology company whose achievements over the past 40 years include Herceptin, the first targeted antibody treatment for cancer which has been (very) effective in breast cancer. In 2009 Genentech merged with the pharmaceutical company Roche and the two combined their pharmaceutical operations in the United States.

What have Genentech discovered so far?

Previous research has shown that in metastatic castrate resistant prostate cancer (mCRPC), a form of advanced prostate cancer that has spread beyond the prostate, the genetic makeupof the cancers varies considerably from patient to patient. Roughly 40-50% of cancers in mCRPC lack a critical protein called PTEN which would normally act as a brake on cancer growth. Patients whose cancers do not have PTEN do not obtain the same benefit from hormone therapies. Initial laboratory studies have suggested that adding ipatasertib to hormone therapy drugs could make these drugs work better.

How exactly does ipatasertib work?

Ipatasertib belongs to a group of drugs called ‘Akt inhibitors’. They are so named because they stop a protein called Akt from working.  Akt is known to regulate how cancer cells grow. Akt is a key part of a network of proteins called the PI3K/Akt pathway, which is overactive in many cancers and which can sometimes become switched on thus helping  cancer cells survive in mCRPC. Ipatasertib can block cancer growth by blocking Akt.

At what stage of development is ipatasertib?

Ipatasertib has been shown to be safe in phase 1 clinical trials. It is now being tested to see if it is safe when it is used along with an immunotherapy drug (Atezolizumab) and a type of chemotherapy (Docetaxel) in patients with advanced prostate cancer who have previously received hormone therapy.

Ipertasertib is also currently being evaluated in a separate phase 3 clinical trial in which it is being used in conjunction with the hormone therapy drug abiraterone (Zytiga). This trial is ongoing but preliminary results are already available. These results suggested that when ipatasertib was combined with the hormone therapy drugabiraterone (Zytiga), it could delay prostate cancer from progressing in men whose  cancers are lacking the PTEN protein. However, further study is required to confirm these findings.

This phase 3 clinical trial will end in late 2023 and if these trials have a positive outcome and if regulatory approval in the UK is successful we estimate that ipatasertib could be available to patients in 2026-27, however there remain many hurdles to be overcome.

Where can I find more information?

Further information about ipatasetrib can be found on Genentech’s website here.

To find out more about how clinical trials work, including the various stages, costs and typical timelines, please click here.

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