AstraZeneca 'enhances options' in immuno-oncology trials for NSCLC

AstraZeneca has rejigged the target of clinical trials for its immuno-oncology treatment for non-small cell lung cancer after "strong efficacy" of its durvalumab drug shown in recent internal and external data as well as "significant opportunities in the competitive landscape".

The FTSE 100 drug giant expects to reveal initial pivotal data from its Mystic trial data in mid-2017 and final data at the latest in 2018, as well as monitoring progress via several undisclosed interim analyses along the way.

Chief medical officer Sean Bohen said the amendments to Mystic and expansion of other connected trials were "all designed to enhance our options" in first-line NSCLC for a combination of immuno-oncology treatments as well as for monotherapy.

Phase three of the Mystic trial, which was initially designed to assess progression-free survival of durvalumab both on its own and in combination with tremelimumab versus standard-of-care chemotherapy for first-line NSCLC, will now also assess overall survival.

The trial will assess patients with PDL1-expressing tumours for both durvalumab monotherapy and the combination therapy, as well as in all-comers for the combination versus standard-of-care chemotherapy.

Astra has also begun to expanded its ongoing phase III Neptune trial in China with local patients to support regulatory submission of durvalumab in combination with tremelimumab for first-line NSCLC patients without delaying the anticipated overall global survival data readout in 2018.

The company said it has also begun the new phase III Pearl trial of durvalumab monotherapy versus standard chemotherapy in first-line NSCLC patients whose tumours express the PD-L1 protein.

Pearl is focused on Asian countries, primarily China, due to the high prevalence of NSCLC in the region.