Project information | Ipatasertib with abiraterone and prednisone for hormone-relapsed metastatic prostate cancer [ID3889] | Guidance

Roche will no longer be pursuing a Marketing Authorisation Application in this indication at this time. The phase 3 trial (IPATential150) met its primary endpoint of rPFS in the PTEN-low/loss population however the magnitude of benefit was not considered sufficient for filing. Additional OS analysis was performed (IA2), which has not yet met statistical significance. Final OS analysis is anticipated mid-2023 but it is unlikely that the final analysis data will be any different from that observed at IA2. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.

Status	Suspended
Technology type	Medicine
Decision	Selected
Process	TA
ID number	3889

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Timeline

Key events during the development of the guidance:

Date	Update
10 November 2023	Following on from information provided to NICE by the company in September 2022, the appraisal of Ipatasertib with abiraterone and prednisone for hormone-relapsed metastatic prostate cancer [ID3889] was suspended from NICE’s work programme. The company will no longer be pursuing a Marketing Authorisation Application in the UK in this indication at this time. Therefore, NICE has decided to discontinue this topic.
15 September 2022	Suspended. Roche will no longer be pursuing a Marketing Authorisation Application in this indication at this time. The phase 3 trial (IPATential150) met its primary endpoint of rPFS in the PTEN-low/loss population however the magnitude of benefit was not considered sufficient for filing. Additional OS analysis was performed (IA2), which has not yet met statistical significance. Final OS analysis is anticipated mid-2023 but it is unlikely that the final analysis data will be any different from that observed at IA2. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.

Date

Update

10 November 2023

Following on from information provided to NICE by the company in September 2022, the appraisal of Ipatasertib with abiraterone and prednisone for hormone-relapsed metastatic prostate cancer [ID3889] was suspended from NICE’s work programme. The company will no longer be pursuing a Marketing Authorisation Application in the UK in this indication at this time. Therefore, NICE has decided to discontinue this topic.

15 September 2022

Suspended. Roche will no longer be pursuing a Marketing Authorisation Application in this indication at this time. The phase 3 trial (IPATential150) met its primary endpoint of rPFS in the PTEN-low/loss population however the magnitude of benefit was not considered sufficient for filing. Additional OS analysis was performed (IA2), which has not yet met statistical significance. Final OS analysis is anticipated mid-2023 but it is unlikely that the final analysis data will be any different from that observed at IA2. Therefore, NICE has decided to suspend this appraisal from its current work programme. As this appraisal has been referred NICE will continue to monitor any development and will update interested parties as and when the situation changes.

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