- AstraZeneca has restarted enrollment in a Phase 3 study of its experimental checkpoint inhibitor durvalumab and plans to resume recruitment in another, now that the Food and Drug Administration has lifted a partial clinical hold on trials of the drug in head and neck cancer.
- Routine safety monitoring of the studies had turned up adverse events related to bleeding, prompting AstraZeneca to pause enrollment and triggering the partial hold in late October.
- The (relatively) quick reversal of the hold is good news for AstraZeneca. Durvalumab is one of its most important R&D assets, one which the British pharma is counting on to help its efforts in oncology.
AstraZeneca will resume both the KESTREL and EAGLE trials without any amendments to either study protocol. For now, new patient enrollment has been restarted at only some of the KESTREL study sites but Astrazeneca will "progressively" resume recruitment for all head and neck cancer trials in the coming days and weeks.
Bleeding, the complication which triggered the hold, is a common adverse event in patients with head and neck squamous cell carcinoma due to the location of tumors and nature of prior treatments, AstraZeneca said in its statement.
Durvalumab is currently being tested against a wide range of cancers across a slew of early-, mid-, and late-stage trials. AstraZeneca hopes to catch immuno-oncology leaders Bristol-Myers Squibb, Merck and Roche, which all have already approved checkpoint inhibitors on the market.
The pharma expects to read out initial data from a pivotal study of durvalumab and tremelimumab in first-line non-small cell lung cancer — one of the most lucrative indications — sometime in the first half of 2017. Overall survival results are not expected until 2018, but AstraZeneca plans to file based on progression-free survival results later that year.
While AstraZeneca has seen good growth from its new cancer drugs Tagrisso (osimertinib) and Lynparza (olaparib), succeeding with durvalumab is crucial to building its oncology franchise and to have a chance of achieving CEO Pascal Soriot's lofty revenue goal for 2023.