Early-stage trial shows strong prospects for AstraZeneca's durvalumab and tremelimumab combo therapy in NSCLC

Anglo-Swedish pharma major AstraZeneca (LSE: AZN) and USA-based biotech R&D subsidiary MedImmune have announced publication in The Lancet Oncology of a Phase Ib study (study 006), showing antitumor activity of combination treatment with durvalumab and tremelimumab, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), irrespective of PD-L1 status. However, AstraZeneca’s shares fell nearly 2% in early morning trading today to £40.30.

In a cohort of 26 patients treated with durvalumab 10-20mg/kg plus tremelimumab 1mg/kg, and followed for ≥24 weeks, the confirmed objective response rate (ORR) was 23% (95% confidence interval 9-44%). Comparable ORRs were seen in patients from this cohort with PD-L1 positive and negative tumors (22% and 29%, respectively). Durvalumab was administered intravenously every four weeks (q4w) for 13 doses or every 2 weeks (q2w) for 26 doses, and tremelimumab was administered q4w for six doses followed by every 12 weeks (q12w) for three doses.

Data on all 56 patients treated with durvalumab 10-20mg/kg q2w or q4w plus tremelimumab 1mg/kg showed a manageable safety profile for an advanced NSCLC population. 30% of patients had ≥1 related Grade 3/4 adverse events (AE) and 16% discontinued treatment due to a related adverse event.