AstraZeneca has released new lung cancer clinical trial data relating to TagrissoTM▼ (osimertinib), and ImfinziTM▼ (durvalumab).
Detailed results from the Phase III ADAURA trial showed AstraZeneca’s Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
In the primary endpoint of DFS in patients with Stage II and IIIA disease, adjuvant treatment (after surgery) with osimertinib reduced the risk of disease recurrence or death by 83% (based on a hazard ratio [HR] of 0.17; 95% confidence interval [CI] 0.12,0.23; p<0.0001). DFS results in the overall trial population, Stage IB through IIIA, a key secondary endpoint, demonstrated a reduction in the risk of disease recurrence or death of 79% (based on a HR of 0.21; 95% CI 0.16, 0.28; p<0.0001).
Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting. The data were presented at the 2020 American Society of Clinical Oncology (ASCO20) Virtual Scientific Program.
The CASPIAN trial met the primary endpoint of OS in June 2019, reducing the risk of death by 27% (equal to hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.59-0.91; p=0.0047).
After a median follow up of more than two years, the latest results for durvalumab plus chemotherapy showed sustained efficacy, maintaining a 25% reduction in the risk of death versus chemotherapy alone (based on a HR of 0.75; 95% CI 0.62-0.91; nominal p=0.0032). Updated median OS was 12.9 months in the experimental arm versus 10.5 months for chemotherapy. In a post-hoc analysis, an estimated 22.2% of patients treated with durvalumab plus chemotherapy were alive at 24 months versus 14.4% for chemotherapy.
For durvalumab plus chemotherapy, 11% of patients were alive and progression-free at 24 months versus 2.9% for chemotherapy (post-hoc). Durvalumab plus chemotherapy maintained a high confirmed objective response rate (ORR) (67.9% versus 58%) and in a post-hoc analysis, duration of response (DoR) for durvalumab plus chemotherapy at 24 months was 13.5% versus 3.9% for chemotherapy. At 24 months, 12% of patients in the durvalumab plus chemotherapy arm remained on durvalumab treatment.