AstraZeneca announced that its Imfinzi (durvalumab) has significantly improved overall survival (OS) in patients with previously-untreated extensive-stage small cell lung cancer (SCLC) in the phase III Caspian study.
Imfinzi, along with four cycles of standard-of-care (SoC) chemotherapy, showed a statistically-significant and clinically-meaningful improvement in OS against SoC including up to six cycles of chemotherapy and optional prophylactic cranial irradiation (PCI).
Imfinzi is a human monoclonal antibody, which binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. It enables to counter the tumour’s immune-evading tactics and releasing the inhibition of immune responses.
Benefits have been noticed in patients treated with Imfinzi plus chemotherapy versus 10.3 months for SoC across all efficacy endpoints.
Caspian is a randomised, open-label, multi-centre, global and phase III study in the first-line treatment of patients with extensive-stage SCLC.
The Caspian study compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy versus chemotherapy alone.
The patients have been treated with up to four cycles of chemotherapy in the experimental arms. AstraZeneca intends to continue the study to the final analysis of OS for the combination of Imfinzi, tremelimumab and chemotherapy.
With OS as the primary endpoint, the study is being carried out in over 200 centres across 22 countries, including the US, Europe, South America, Asia and the Middle East.
Imfinzi was already approved for previously-treated patients with advanced bladder cancer in ten countries, including the US.
In addition, Imfinzi is being tested as a monotherapy and in combination with tremelimumab under a broad development programme.
AstraZeneca oncology R&D executive vice president José Baselga said: “We are encouraged to see more than a third of small cell lung cancer patients treated with Imfinzi plus chemotherapy alive at the 18-month landmark, which is remarkable given the aggressive nature of the disease.
“It is also noteworthy that these results may enable physicians to choose Imfinzi in combination with either cisplatin or carboplatin chemotherapy backbones.”