KEY TAKEAWAYS
- The LATIFY phase III study aimed to evaluate the efficacy and safety of ceralasertib + durvalumab vs. docetaxel in advanced NSCLC pts.
- The primary endpoint is to assess OS. Secondary endpoints include evaluating PFS, PK, ORR, DCR, and safety.
- The study’s result will determine whether ceralasertib + durvalumab is an effective and safe treatment option for NSCLC pts.
Patients(pts) with metastatic non-small cell lung cancer (mNSCLC) who have progressed on immunotherapy or chemotherapy have limited treatment options. Ceralasertib and durvalumab are two drugs that may help to sensitize tumors to immunotherapy by targeting different pathways.
Combining ceralasertib and durvalumab may boost the immune system to fight cancer. In the ongoing phase 2 HUDSON study, ceralasertib + durvalumab showed promising efficacy with a median progression-free survival (PFS) of 6.0 months (80% CI, 4.6–7.5) and a median overall survival (OS) of 15.9 months (80% CI, 14.1–20.3). Researchers aimed to evaluate the efficacy and safety of ceralasertib + durvalumab vs. docetaxel in pts with advanced NSCLC.
This study’s key inclusion criteria require pts must be 18 years of age or older and have an ECOG performance status of 0 or 1, documented EGFR and ALK wild-type status, and adequate organ and bone marrow function. Stable brain metastases are allowed. Eligible pts should be suitable for second- or third-line therapy and have previously received both anti-PD-(L)1 therapy and a platinum-containing doublet regimen for locally advanced or mNSCLC, either separately or in combination, with no other prior therapies. Exclusion criteria consist of mixed small-cell lung and NSCLC histology, unresolved toxicities of Grade ≥2 (NCI CTCAE v5.0) from prior therapy, active or prior autoimmune or inflammatory disorders, more than one line of previous anti-PD-(L)1 therapy (alone or in combination), and more than one line of platinum-based chemotherapy in a metastatic setting. Pts are randomly assigned in a 1:1 ratio to receive either oral ceralasertib 240 mg twice daily on Days 1–7 with IV durvalumab 1,500 mg on Day 8 within a 28-day cycle or IV docetaxel 75 mg/m2 on Day 1 within a 21-day cycle.
The primary endpoint is to assess OS. Secondary endpoints include evaluating PFS, overall response rate (ORR), disease control rate (DCR), duration of response, time to second progression or death, OS at 12 months, time to deterioration of health-related quality of life (QoL), and physical function, and the pharmacokinetics (PK) of ceralasertib. The study will enroll 580 pts from 21 countries, including the Americas, Europe, and Asia Pacific.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.TPS9161?af=R
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05450692
Benjamin Besse, Gilberto Castro, Enriqueta Felip, Katerina A. Politi, Toshiaki Takahashi, Jie Wang, Emma Dean, Melissa Deans, Helen Broadhurst, Piruntha Thiyagarajah, and Patrick M. Forde. DOI: 10.1200/JCO.2023.41.16_suppl.TPS9161 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) TPS9161-TPS9161.
