Company: AZN
Filing Date: 2025-12-22
Form Type: 6-K
Source: 0001654954-25-014164
Chunk: 1

Company: ASTRAZENECA PLC
Filing Date: 2025-12-22
Form: 6-K
Chunk 1
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 the LATIFY trial was to reinvigorate the immune response of patients with lung cancer whose tumours stopped responding to available therapies by combining ATR inhibition with immunotherapy. While we are disappointed by this result, we remain committed to pioneering new medicines to address the urgent need to improve outcomes for patients with lung cancer through our industry-leading portfolio."

The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting.

#### Notes

#### NSCLC
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 1 Lung cancer is broadly split into small cell lung cancer (SCLC) or NSCLC, the latter accounting for about 80-85% of cases. 2-3 Patients are most commonly diagnosed with metastatic disease, when the tumour has spread outside the lung. 4 Approximately 12% of people with metastatic NSCLC will still be alive five years after diagnosis. 5

#### LATIFY
LATIFY is a randomised, open-label, multi-centre, global Phase III trial of ceralasertib plus Imfinzi in patients with locally advanced or metastatic NSCLC without AGAs, and whose disease has progressed on or after prior anti-PD-(L)1 therapy and platinum-based chemotherapy. Patients were randomised 1:1 to receive ceralasertib 240mg twice daily oral tablets for seven days in combination with a 1,500mg fixed dose of Imfinzi on day eight every four weeks or docetaxel every three weeks until disease progression, unacceptable toxicity, withdrawal of consent or a discontinuation criterion was met.

The trial enrolled 594 patients across more than 20 countries. The primary endpoint is OS and secondary endpoints include progression-free survival, objective response rate, duration of response, time to response, disease control rate and patient reported outcomes.

#### Ceralasertib
Ceralasertib is an oral, potent and selective inhibitor of the ATR kinase, which is crucial for DNA damage responses and cell survival. Ceralasertib acts on the tumour microenvironment, moving it from a suppressed immune state into an activated state when combined with immunotherapy.

#### Imfinzi
Imfinzi (durvalumab) is a human monoclon