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AstraZeneca Provides Update On MYSTIC Trial Timeline

(AstraZeneca) Mar 12, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced an updated timeline for the final analysis of the Phase III MYSTIC trial of Imfinzi (durvalumab) as monotherapy and in combination with tremelimumab, versus platinum-based standard-of-care (SoC) chemotherapy in previously-untreated patients with metastatic (Stage IV) 1st-line non-small cell lung cancer (NSCLC).

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H. Jack West, MD (Posted: March 12, 2018)

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We will review these data in comparison to the CheckMate-227 trial results expected to be presented in the next several weeks (which will include positive findings for PFS based on tumor mutational burden, but OS results are reportedly still immature, so we can't expect to see OS data), as well as the rapidly growing collection of data on chemo combined with PD-(L)1 inhibitors, most notably KEYNOTE-189. This trial is also expected to be presented soon (at AACR, I understand) and focuses on the regimen of carbo/pemetrexed/pembrolizumab that already has the major advantages of being FDA approved (based on the phase II KEYNOTE-021g trial) and being the chemo backbone most favored by US-based oncologists for non-squamous NSCLC.

There are certainly opportunities to enter the first line advanced NSCLC setting, especially for squamous NSCLC, but nivolumab/ipilimumab will be the first immunotherapy combination to be broadly discussed and show positive data. The durvalumab/tremelimumab regimen will become a relevant regimen if it demonstrates a significant survival benefit, provided that toxicity isn't prohibitive.

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