Biotech Values

[DewDiligence]

AZN modifies design of I-O trial in first-line NSCLC:

https://www.astrazeneca.com/media-centre/press-releases/2017/astrazeneca-expands-1st-line-lung-cancer-immuno-oncology-programme-opportunities-17012017.html

AstraZeneca today provides an update on its Immuno-Oncology (IO) late-stage clinical development programme in 1st-line non-small cell lung cancer (NSCLC), including a refinement of the Phase III MYSTIC trial.

The MYSTIC trial was initially designed to assess the benefit of durvalumab monotherapy and durvalumab and tremelimumab (durva + treme) combination therapy versus standard-of-care (SoC) chemotherapy, focused on progression-free survival (PFS).

The MYSTIC trial will now assess PFS and overall survival (OS) endpoints in patients with PDL1-expressing tumours for both durvalumab monotherapy and the combination of durva + treme, as well as in ‘all comers’ for the combination of durva + treme, versus SoC chemotherapy.

While the focus remains on exploring the benefit of durva + treme as combination therapy, the Company has updated the endpoints of the MYSTIC trial to include OS and PFS in durvalumab monotherapy. This is based on recent internal and external data, including durvalumab’s strong efficacy in monotherapy presented at recent medical meetings, as well as significant opportunities in the competitive landscape.

The estimated primary completion date has been updated to reflect both an increase in patient recruitment (as reported in February 2016 with the inclusion of OS as a co-primary endpoint) and the event-based nature of the trial. As a result, the Company anticipates MYSTIC PFS data in mid-2017 and final OS data at the latest in 2018. MYSTIC also includes several undisclosed interim analyses for OS.

The impetus for the change was presumably the outcome of MRK’s Keytruda trials in first-line NSCLC.