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AZ pushes back data read-out from MYSTIC lung cancer trial

The delay could further undermine confidence in a positive outcome

AstraZeneca building

AstraZeneca has delayed reporting the overall survival data from its much-anticipated MYSTIC trial of its immuno-oncology combination by what could be a few months.

The timeline for reporting the data has now been pushed into the second half of this year, having previously been scheduled to be ready before the end of June, the company said this morning in a brief statement.

The MYSTIC overall survival result is a key data read-out for AZ’s PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 inhibitor tremelimumab in non-small cell lung cancer (NSCLC), as the combination failed to have an impact on the first endpoint in the study - progression-free survival (PFS) - which was reported last July.

MYSTIC pits Imfinzi - with and without tremelimumab - against standard chemotherapy as a first-line treatment for patients with locally-advanced or metastatic NSCLC.

AZ shares fell sharply after the PFS data from the study was reported last year, which scuppered its hopes of a push into the lucrative first-line NSCLC setting and raised questions about the validity of combining PD-1/PD-L1 and CTLA4 inhibitors in these patients.

At the time, AZ insisted that it was premature to write off its combination until the overall survival data had come in, but the delay could further undermine confidence in a positive outcome given the PFS miss. It’s worth noting however that MYSTIC has an event-driven protocol, which is known to make the estimation of timelines challenging for immuno-oncology studies, in part because a proportion of patients can remain alive or disease-free even after long-term follow-up.

Meanwhile, a similar approach has been trialled by Bristol-Myers Squibb with Its PD-1 inhibitor Opdivo (nivolumab) and CTLA4 blocker Yervoy (ipilimumab). BMS had its own big setback in first-line NSCLC and effectively had to cede that portion of the market to rival Merck & Co’s Keytruda (pembrolizumab) but - last month - reported that its pairing extended PFS in the CheckMate-227 trial in patients with high tumour mutation burden (TMB) compared to chemo.

TMB differs from the usual PD-L1 expression biomarker used in trials of PD-1/PD-L1 inhibitors and has been proposed as a superior option for immuno-oncology drugs, as a high reading indicates more markers on the cancer cell surface that make them vulnerable to this type of therapy.

Since MYSTIC’s first data read-out BMS has also reported positive overall survival results for Opdivo and Yervoy in kidney cancer - also after negative PFS data - which further backs the validity of the combination.

AZ has also found another route to unlock the big lung cancer market with Imfinzi, claiming approval last month for the drug as a maintenance therapy for NSCLC patients with inoperable stage III disease, ie that has not spread widely around the body after platinum chemotherapy or radiotherapy.

Article by
Phil Taylor

12th March 2018

From: Research

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