For information, the company have announced that the Phase III KEYLYNK-008 Trial did not meet its co-primary endpoints in demonstrating an improvement in overall survival (OS) or progression-free survival (PFS) at the second interim analysis, and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time.
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 | STA Standard |
| ID number | 4006 |
Email enquiries
- If you have any queries please email scheduling@nice.org.uk
Timeline
Key events during the development of the guidance:
| Date | Update |
|---|---|
| 02 January 2024 | Suspended. For information, the company have announced that the Phase III KEYLYNK-008 Trial did not meet its co-primary endpoints in demonstrating an improvement in overall survival (OS) or progression-free survival (PFS) at the second interim analysis, and therefore they will no longer be pursuing a Marketing Authorisation Application in this indication at this time. 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. |
| 16 November 2023 - 30 November 2023 | Consultation on suggested remit, draft scope and provisional stakeholder list of consultees and commentators: 4006 |
| 30 November 2023 | The National Institute for Health and Care Excellence (NICE) has been asked to conduct an appraisal of pembrolizumab with olaparib for maintenance treatment of advanced squamous non-small-cell lung cancer ID4006. We have recently invited stakeholders to respond to a written consultation on the draft scope for this appraisal. Following an update from the company that market the drug, NICE will not be progressing with the scoping exercise at this stage. The consultation on the draft scope will now close. Please accept our apologies for any inconvenience. |
| 16 November 2023 | In progress. Scoping commencing |
| 10 October 2023 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early February 2024 when we will write to you about how you can get involved. |
| 31 July 2023 | Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, we now anticipate that the appraisal will begin during early March 2024 when we will write to you about how you can get involved. |
| 27 March 2023 | Following the changes to remove technical engagement as standard from appraisal timelines, the timelines for the appraisal of Pembrolizumab with olaparib for maintenance treatment of advanced squamous non-small-cell lung cancer have been revised. It is anticipated that the appraisal will begin in late-August 2023 when we will write to you about how you can get involved. |
For further information on our processes and methods, please see our CHTE processes and methods manual