Detailed results from the phase III CASPIAN trial were presented at IASLC 2019 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain.
Durvalumab ( Imfinzi ) has significantly improved overall survival ( OS ) in patients with previously-untreated extensive-stage small cell lung cancer ( SCLC ).
Durvalumab in combination with four cycles of standard-of-care ( SoC ) chemotherapy ( Etoposide with either Cisplatin or Carboplatin ) has demonstrated a statistically-significant and clinically-meaningful improvement in overall survival versus standard-of-care consisting of up to six cycles of chemotherapy and optional prophylactic cranial irradiation ( PCI ).
The risk of death was reduced by 27% ( equal to a hazard ratio of 0.73 ), with median overall survival of 13.0 months for Durvalumab plus chemotherapy versus 10.3 months for standard-of-care.
Results have shown a prolonged overall survival benefit with an estimated 33.9% of patients alive at 18 months following treatment with Durvalumab plus chemotherapy versus 24.7% of patients following standard-of-care.
Across all efficacy endpoints, benefits were observed in patients treated with Durvalumab plus chemotherapy versus standard of care.
Results have shown a significantly higher progression-free survival ( PFS ) rate at 12 months ( 17.5% vs. 4.7% ), a 10.3% increase in confirmed objective response rate ( ORR ) ( 67.9% vs. 57.6% ), and improved duration of response ( DOR ) at 12 months ( 22.7% vs. 6.3% ).
The safety and tolerability of Durvalumab in combination with standard-of-care Etoposide and Platinum-based chemotherapy was consistent with previous trials.
Results have shown that 61.5% of patients experienced a grade 3 or 4 adverse effects with Durvalumab plus standard-of-care ( all causes ) versus 62.4% with standard-of-care, and patients discontinuing treatment due to adverse effects were similar between arms ( 9.4% vs. 9.4% ).
The CASPIAN trial is a randomised, open-label, multi-centre, global, trial in the 1st-line treatment of patients with extensive-stage small cell lung cancer.
The trial has compared Durvalumab in combination with Etoposide and either Cisplatin or Carboplatin chemotherapy, or Durvalumab, Tremelimumab and chemotherapy versus chemotherapy alone.
In the experimental arms, patients were treated with up to four cycles of chemotherapy. In comparison, the control arm allowed up to six cycles of chemotherapy and optional PCI.
The primary endpoint is overall survival.
Lung cancer is the leading cause of cancer death among both men and women and accounts for about one-fifth of all cancer deaths.
Lung cancer is broadly split into NSCLC and SCLC, with about 15% classified as SCLC.
About three quarters of SCLC patients are diagnosed with extensive-stage disease, in which the cancer has spread widely through the lung or to other parts of the body. Prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.
Durvalumab is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. ( Xagena )
Source: AstraZeneca, 2019