It’s been a busy morning at AstraZeneca PLC (LON:AZN). The UK drug giant this morning announced that it has refined its MYSTIC trial, has submitted an application to expand its NEPTUNE study, and has initiated a new phase III PEARL trial in Asia.
The MYSTIC trial – arguably the ‘big one’ for Astra – is designed to assess the benefit of durvalumab monotherapy as well as a durvalumab and tremelimumab (durva and treme) combination therapy versus chemotherapy in non-small-cell lung cancers (NSCLC).
It was initially focused on progression-free survival – the length of time during and after treatment that a patient lives with the disease but it doesn’t get worse, but it has now been updated to assess overall survival – how long a patient lives after treatment – as well.
The durva/ treme combination therapy is still seen as the key part of the trial, but the monotherapy endpoints have also been updated based on “strong” internal and external data, Astra said.
The company said it expects PFS data from MYSTIC in mid-2017, with OS data due out by 2018 “at the latest”.
Elsewhere, the ongoing phase III NEPTUNE trial is to be expanded with local patients to support the regulatory submission of durva and treme combination therapy in China for first-line NSCLC patients.
This won’t delay the readout of results though, which is expected in 2018.
Astra also said it has begun the phase III PEARL study of durva monotherapy against chemotherapy in treating first-line NSCLC patients.
This particular study is focused solely on Asian countries, given the comparatively high prevalence of NSCLC patients in the region.
“The MYSTIC trial amendments, the NEPTUNE trial expansion and initiation of the new PEARL trial are all designed to enhance our options in 1st-line NSCLC for IO (immune-oncology)-IO combination as well as for IO monotherapy,” explained chief medical officer Sean Bohen.
“We continue to follow the science through both internal and external sources for the benefit of patients and look forward to sharing our first pivotal data in mid-2017.”
High hopes for durva and MYSTIC
Durvalumab is the drug the company – and investors – have the highest hopes for and is intended to be used in combination with other drugs to fight cancer.
The MYSTIC study in particular is thought of as a potential company maker or breaker by the markets following ‘robust’ data from previous trials.
Most of the City agrees that this key study is riskier than the typical phase III, and is estimated to have less than a 50% chance of success.
If it is successful though, analysts reckon the trial could be one of the major growth drivers for Astra in the coming years.
Shares were up 20p to £45.95.