Efficacy and safety data from two Phase I trials evaluating durvalumab in combination with tremelimumab in 2nd-line immunotherapy-naïve patients with either non-squamous advanced non-small cell lung cancer (NSCLC) (Study 006) or metastatic urothelial carcinoma (mUC) (Study 10) has been presented at the American Association for Cancer Research (AACR) Annual Meeting 2018.

Dr Guru Sonpavde spoke with ecancer about using this combination to treat mUC at the ASCO GU conference in February.

The Study 006 long-term follow-up results showed clinical activity in both PD-L1 ≥25% and <25% groups.

Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, PD-L1 cut-off: ≥25% of tumour cells with membrane staining.

The combination of durvalumab and tremelimumab demonstrated a manageable safety profile in patients with advanced NSCLC.

The most common treatment-related adverse events (AEs) were fatigue (19%), pruritus (17%), diarrhoea (15%), reduced appetite (14%) and rash (14%).

14 patients (7%) experienced a treatment-related AE that led to treatment discontinuation, and 23% experienced a Grade 3/4 treatment-related AE.

There was one treatment-related death (multifactorial hypoxia).

In Study 10, the combination of durvalumab plus tremelimumab showed clinical activity in previously treated mUC, regardless of PD-L1 status.

Tumour and immune-cell PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay, PD-L1 cut-off: ≥25% of tumour and immune cells with membrane staining.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said “The mature data sets from these Phase I trials help further characterise the overall survival of durvalumab plus tremelimumab combination in 2nd-line non-squamous non-small cell lung cancer and 2nd-line metastatic urothelial carcinoma. We look forward to exploring whether OS is distinguished from durvalumab monotherapy in our Phase III MYSTIC and DANUBE trials, expected to read out later this year and next year, respectively.”

Source: Globe Newswire