Key Clinical Summary: 

• Design/Population: The phase 3 LATIFY trial randomized 594 patients with advanced NSCLC who progressed after anti–PD-L1 therapy and platinum-based chemotherapy. Patients received either ceralasertib plus durvalumab or docetaxel.
• Key Outcomes: The combination did not improve overall survival, progression-free survival, or objective response rate compared with docetaxel. Grade ≥3 adverse events were less frequent with the combination, although overall toxicity rates were similar.
• Clinical Relevance: These findings do not support the use of ATR inhibition combined with immunotherapy in this setting. Docetaxel remains a standard option after progression on prior immunotherapy and chemotherapy.

Final results from the phase 3 LATIFY trial demonstrated that ceralasertib plus durvalumab did not improve survival outcomes compared with docetaxel among previously treated patients with advanced non-small cell lung cancer (NSCLC).

These results were presented at the European Lung Cancer Congress in Copenhagen, Denmark, by Benjamin Besse, MD, PhD, Gustave Roussy Institute, Villejuif, France.

In this open-label study, 594 patients who experienced disease progression after treatment with an anti–PD-L1 inhibitor and platinum-based chemotherapy were randomized 1:1 to receive 240 mg of twice daily ceralasertib on days 1 through 7 plus 1500 mg of durvalumab on day 8 in 28-day cycles (n = 299) or 75 mg/m² docetaxel on day 1 in 21-day cycles (n = 295), until disease progression or unacceptable toxicity. The primary end point was overall survival (OS). Key secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety.

At analysis, median OS was 11.1 months in the ceralasertib plus durvalumab arm and 10 months in the docetaxel arm, with 12-month OS rates of 46.3% and 43.6%, respectively. Median PFS was 4.1 months in both treatment arms, with 6-month PFS rates of 35.3% in the ceralasertib plus durvalumab arm and 33.5% in the docetaxel arm. The ORR was 7.7% in the ceralasertib plus durvalumab arm and 17.3% in the docetaxel arm. The median duration of exposure was 4.5 months with ceralasertib, 3.8 months with durvalumab, and 3months with docetaxel. 

Treatment-related adverse events of any grade were reported in 86.2% of patients in the ceralasertib plus durvalumab arm and 85.8% of patients in the docetaxel arm. Grade ≥3 treatment-related adverse events occurred in 26.9% and 43.8% of patients, respectively. All-cause adverse events led to treatment discontinuation in 7.7% of patients in the ceralasertib plus durvalumab arm and 11.3% of patients in the docetaxel arm.

“[Ceralasertib plus durvalumab] did not demonstrate a statistically significant improvement in OS vs docetaxel,” concluded Dr Besse. “[Ceralasertib plus durvalumab] had manageable toxicity and [adverse events] were consistent with the known safety profiles of each agent.”

Source:  

Besse B, et al. Ceralasertib (C) + durvalumab (D) in patients (pts) with locally advanced (LA) or metastatic (m) NSCLC who progressed on or after anti-PD-(L)1 and platinum-based chemotherapy (CT): Results from LATIFY. Presented at European Lung Cancer Congress. March 28 - 28, 2026. Copenhagen, Denmark. LBA1.