AstraZeneca announced Tuesday that the FDA lifted a partial clinical hold on the enrolment of new patients with head and neck squamous cell carcinoma (HNSCC) in studies of durvalumab as a monotherapy and combinations of the PD-L1 inhibitor with tremelimumab and other drugs.
The partial clinical hold came into effect last month after bleeding events were seen in studies of durvalumab in patients with HNSCC. The drugmaker noted at the time that it had voluntarily halted enrolment of new patients with HNSCC while an analysis was undertaken of adverse events associated with bleeding as observed during routine safety monitoring of the Phase III KESTREL and EAGLE trials.
AstraZeneca said Tuesday that the FDA lifted the partial clinical hold after reviewing the analysis of bleeding events. The company added that "bleeding is a known complication in treatments of head and neck cancers primarily due to the nature of the underlying disease, the proximity of tumours to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation."
The drugmaker indicated that the KESTREL study has already re-opened for new patient enrolment, while the EAGLE trial is expected to resume recruitment shortly, without amendments to either protocol. For related analysis, see ViewPoints: AstraZeneca’s wobble points spotlight on safety of I/O combinations.
Earlier this month, AstraZeneca disclosed that it will not seek approval of durvalumab in head and neck cancer based on Phase II study results. The company cited "recent changes in the...competitive landscape," including the FDA approval of Merck & Co.'s anti-PD-1 therapy Keytruda (pembrolizumab) in August for the treatment of patients with recurrent or metastatic HNSCC.
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