AstraZeneca has submitted the first marketing application in Europe for its immunotherapy Imfinzi, seeking approval for the drug’s use to treat a subset of patients with lung cancer.
The submission requests approval of Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) 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 “is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting,” Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca, said earlier this year.
The drug, a human monoclonal antibody directed against PD-L1, has 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.
Meanwhile, Imfinzi has also received accelerated approval in the US 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.
It is also being investigated for the adjuvant treatment of patients with NSCLC in the CCTG (Canadian Cancer Trials Group) trial ADJUVANT (BR31), while, in the MYSTIC, NEPTUNE, and PEARL Phase III trials, Imfinzi is being studied for first-line treatment as monotherapy and/or in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody, for the treatment of metastatic NSCLC. The POSEIDON trial is investigating the immunotherapy with and without tremelimumab in combination with chemotherapy in the same population.