US regulators have accepted an application by AstraZeneca and MedImmune to expand the scope of Imfinzi (durvalumab) to include patients with a certain form of lung cancer.
The US Food and Drug Administration will give a priority review to the submission, which seeks approval to market the drug for locally advanced (Stage III) unresectable non-small cell lung cancer (NSCLC) in patients whose disease has not progressed following platinum-based chemoradiation therapy.
According to AZ, patients with this earlier stage of lung disease need better treatment options and outcomes, given that the current standard of care is active monitoring following concurrent chemoradiation.
The application centres on positive data from the Phase III PACIFIC trial, which showed statistically-significant and clinically-meaningful improvements in progression-free survival (PFS) in patients taking the drug versus placebo.
Imfinzi, a human monoclonal antibody directed against PD-L1, has already been awarded breakthrough status in the US for the same indication, signalling that regulators believe it has the potential to offer a benefit at this earlier stage in the treatment pathway.
The drug also has an accelerated approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.
Promising data for savolitinib
Meanwhile, AZ and Hutchison China MediTech presented preliminary safety and clinical activity data of savolitinib when given in combination with either Tagrisso (osimertinib) or Iressa (gefitinib) in two Phase Ib/II proof-of-concept trials conducted in patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC with MET-amplification who had progressed following first-line treatment with an EGFR inhibitor.
In both trials, the addition of savolitinib, an investigational selective inhibitor of mesenchymal epithelial transition factor receptor tyrosine kinase, to Tagrisso or Iressa demonstrated preliminary anti-tumour activity, according to presented at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Yokohama, Japan.